Received: 10 November 2021 Revised: 3 July 2022 Accepted: 29 July 2022

DOI: 10.1111/jcpe.13714

ORIGINAL ARTICLE

Clinical and radiographic outcomes of customized allogeneic

bone block versus autogenous bone block for ridge
augmentation: 6 Month results of a randomized controlled
clinical trial

Maoxia Wang1 | Yazhen Li2 | Zhenya Su3 | Anchun Mo3

1
West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China
2
State Key Laboratory of Oral Diseases and National Clinical Research Center for Oral Diseases and Department of Orthodontics, West China Hospital of
Stomatology, Sichuan University, Chengdu, China
3
State Key Laboratory of Oral Diseases and National Clinical Research Center for Oral Diseases and Department of Oral Implantology, West China Hospital of
Stomatology, Sichuan University, Chengdu, China

Correspondence
Anchun Mo, State Key Laboratory of Oral
Diseases and National Clinical Research
Center for Oral, Diseases and Department of
Oral Implantology, West China Hospital of
Stomatology, Sichuan University, No. 14., 3rd
Sec, Ren Min Nan Road, Chengdu 610041,
China.
Email: moanchun@163.com
Funding information
Sichuan Health Research Project, Grant/Award
Number: 19ZD008; the Clinical Research
Project of West China Hospital of
Stomatology, Sichuan University, Grant/Award
Number: LCYJ2020-YF-2
Abstract
Aim: To evaluate the efficacy of customized allogeneic bone block (CABB) for ridge
augmentation compared with autogenous bone block.
Materials and Methods: Patients (N = 24) in need of ridge augmentation were ran-
domly assigned to one of two treatment modalities: CABBs (CABB group) and autog-
enous bone blocks (ABB group). The primary outcome of the present study was the
horizontal bone gain at 1 mm below the alveolar ridge crest (HBG1). Secondary out-
comes were the bone gain at other levels, bone resorption rate, ridge width, operative
time, postoperative pain score, and histological results. The data obtained from the
current study were analysed using a generalized linear mixed effects model, two-
sample t-test, or a Mann–Whitney U-test.
Results: Twenty-four patients completed a 6-month follow-up. One patient in the
CABB group exhibited block exposure. The CABB group had significantly more hori-
zontal bone gain (HBG1) and less horizontal bone resorption (HBRR1) at 1 mm below
the alveolar ridge crest when compared with those in the ABB group (HBG1: CABB
group [4.29 ± 1.48 mm] and ABB group [1.12 ± 3.25 mm]; HBRR0: CABB group
[42.15 ± 14.03%] and ABB group [92.52 ± 55.78%], p < .05). In addition, a longer
operative time was reported in the ABB group compared with the CABB group
(p < .05). The histological observation indicated a new bone formation in both groups.
Conclusions: The use of CABBs resulted in more horizontal bone gain and less hori-
zontal bone resorption at 1 mm below the alveolar ridge crest at 6 months post-
surgery compared with ABBs while reducing the operative time in the treatment of
ridge augmentation.

KEYWORDS
alveolar ridge augmentation, autogenous bone block, customized allogeneic bone block, graft
remodelling, randomized controlled clinical trial

22 © 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. wileyonlinelibrary.com/journal/jcpe J Clin Periodontol. 2023;50:22–35.
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WANG ET AL. 23

Clinical Relevance
Scientific rationale for study: Autogenous bone grafting is the most well-documented treatment
for ridge augmentation. However, the donor site morbidity, long surgery time, high technique
sensitivity, and low acceptance by the patients have limited the clinical application of autoge-
nous bone blocks (ABBs) in ridge augmentation. Therefore, in the present study, customized
allogeneic bone blocks (CABBs) were proposed as an alternative treatment option for bone
regeneration.
Principal findings: The use of CABBs resulted in more horizontal bone gain and less bone resorp-
tion at 1 mm below the alveolar ridge crest at 6 months post-surgery compared with ABBs while
reducing the operative time in the treatment of ridge augmentation.
Practical implications: CABBs provide a promising alternative treatment option for bone
regeneration.

1 | I N T RO DU CT I O N components of the donor's bone, allogeneic bone blocks can also be

Currently, dental implants are widely applied as a preferred treatment
for missing teeth (Buser et al., 2017). However, insufficient bone vol-
ume following tooth removal can compromise the three-dimensional
position of implants and impair the aesthetic outcome of implant ther-
apy (Buser et al., 2004; Tan et al., 2012; Benic & Hammerle, 2014).
Thus, multiple techniques have been developed for alveolar ridge
reconstruction, such as autogenous bone block (ABB) grafting, ridge
splitting, distraction osteogenesis, and guided bone regeneration
(Chiapasco et al., 2006; Froum et al., 2008; Retzepi & Donos, 2010;
Bassetti et al., 2016). ABB grafting is a well-documented treatment
for large bone defects (Jensen & Terheyden, 2009; Benic &
Hammerle, 2014). Substantial long-term clinical evidence has docu-
mented the high survival and success rates of implants after ridge aug-
mentation using ABBs (Nyström et al., 2009; Cordaro et al., 2011;
Chappuis et al., 2017; Verdugo et al., 2017). Previous studies have
reported the horizontal bone gain of 2.7–4.3 mm and vertical bone
gain of 2.1–6.5 mm at sites augmented with ABBs, with horizontal
bone resorption rate of 21%–28% and vertical bone resorption rate of
22%–44% (Cordaro et al., 2002, 2010; Morad & Khojasteh, 2013; Al-
Nawas & Schiegnitz, 2014; Park et al., 2017; Elnayef et al., 2018;
Hameed et al., 2019; Urban et al., 2019). However, donor site morbid-
ity, such as fracture, hematoma, altered nerve sensation, infection,
and pain, are the major drawbacks of ABBs. The rate of complication
with the autograft harvested from intra- or extra-oral sites has been
reported to be 27.8%–63.6% (Scheerlinck et al., 2013). In addition,
long surgery time, high technique sensitivity, and low patients' accep-
tance also limit the clinical application of ABBs (McAllister &
Haghighat, 2007; Nkenke & Neukam, 2014).
Given the deficiencies of autogenous grafts, allogeneic, xenoge-
neic, and synthetic bone blocks have been suggested as potential
alternatives for ridge augmentation (Peleg et al., 2010; Giuliani
et al., 2016; Benic et al., 2019). Among them, allogeneic bone blocks
are the best-documented alternative to ABBs. Allograft can be classi-
fied as fresh-frozen bone allograft, freeze-dried bone allograft, and
demineralized freeze-dried bone allografts according to the proces-
sing technique (Benic & Hammerle, 2014). Depending on the
divided into cortical bone blocks, cancellous bone blocks, and corti-
cocancellous bone blocks (Nissan et al., 2008; Spin-Neto
et al., 2015). Since allograft was first used in orthopaedics in 1880, it
has been gradually applied in alveolar defect regeneration because
of its advantages of good osteoconductivity, absence of donor site
morbidity, unlimited availability, and decreased surgery time
(de Boer, 1988; Laino et al., 2014; Chavda & Levin, 2018). In a
12-month retrospective study, Kloss et al. (2018) reported that the
efficacy of allogeneic bone blocks was similar to ABBs in the treat-
ment of circumscribed bone defects. Besides, several systematic
reviews have reported that allogeneic bone blocks could achieve a
weighted mean horizontal bone gain of 4.79 mm and vertical bone
gain of 2 mm, with a bone resorption rate of 10%–52% (Monje
et al., 2014; Urban et al., 2019). Meanwhile, mounting histological
evidence has documented the formation of new bone and blood ves-
sels in allogeneic bone blocks during the bone-healing period (Spin-
Neto et al., 2015; Blume, Donkiewicz, et al., 2019; Chaushu
et al., 2019). However, the complication rate of allogenic bone
blocks, ranging from 0% to 60%, varied widely among the previous
studies (Draenert et al., 2016; Urban et al., 2019).
Despite the above-mentioned advantages of allogeneic bone
blocks, the precise shaping and positioning of bone blocks are still
time-consuming and depend on the surgeons' experience. Incorpora-
tion of digital technology has opened new treatment avenues for
bone regeneration. The computer-aided design/computer-aided
manufacturing (CAD/CAM) process has enabled the manufacture of
customized bone blocks more simply and efficiently. Recently, a
5-year follow-up case report showed the stable bone regeneration
outcomes of customized allogeneic bone blocks (CABBs) (Kloss
et al., 2020). Although CAD/CAM manufactured CABBs seem to be a
promising method in ridge augmentation, most published reports
about CABBs showed insufficient evidence quality (Schlee &
Rothamel, 2013; Blume et al., 2018; Blume, Back, et al., 2019; Blume,
Donkiewicz, et al., 2019; Kloss et al., 2020). To the authors' knowl-
edge, there were no randomized controlled trials that compared the
efficacy of CABBs with ABBs. The clinical outcome of CABBs in ridge
augmentation is required for future research.

24
Therefore, the aim of this clinical trial was to evaluate the efficacy
of CABB for ridge augmentation compared with ABB. The null
hypothesis was that there is no difference in clinical and radiographic
measurements between these treatment modalities.
2 | MATERIALS AND METHODS
This study followed the CONSORT guidelines for reporting parallel
group randomized trials (Schulz et al., 2010).
2.1 | Trial design
This study was a randomized, controlled, single-blind (outcome asses-
sor) monocentric study with two parallel groups over 6 months. The
study was approved by the ethical committee of West China Hospital
of Stomatology, Sichuan University (WCHSIRB-D-2019-068) and reg-
istered in the Chinese Clinical Trial Registry (www.chictr.org.cn,
ChiCTR2000032642). The study was conducted at the Department of
implant dentistry, West China Hospital of Stomatology, Sichuan Uni-
versity, China. The study was carried out based on the guidelines of
the Declaration of Helsinki. Participants were included from May
2020 to October 2020. All the participants gave written informed
consent before recruitment into the trial.
2.2 | Eligibility criteria
The inclusion criteria for this study were as follow:
• male or female patients aged 18–60 years (including 18 and
60 years);
• more than 3 months after tooth extraction;
• ridge width at 1 mm below the alveolar ridge crest ≤4 mm and ver-
tical bone loss ≤4 mm (based on the pre-operative cone-beam
computed tomography [CBCT] images);
• number of missing teeth in the defect area ≤4;
• good general health;
• good oral hygiene and control of inflammation in the whole denti-
tion (full-mouth plaque score < 25%; bleeding on probing score,
BOP% < 10%);
• subjects are fully aware of the benefits and risks of the trial and
are willing to participate in the trial and sign the informed consent.
The exclusion criteria for this study were as follows:
• patients with any contraindications to oral surgery, such as heart
function disease of grade II and above, uncontrolled diabetes
(HbA1c > 7%), and abnormal coagulation function;
• untreated periodontitis (probing pocket depths ≥ 4 mm with BOP,
BOP% > 10%);
• systemic infection or local acute infection of the surgical site;
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WANG ET AL.
• use of drugs that may affect the healing of hard and soft tissues,
such as long-term use of adrenal corticosteroids or
bisphosphonates;
• heavy smokers (smoking more than 20 cigarettes/day);
• history of radiation therapy;
• known allergic to the materials used in the product;
• women in pregnancy or lactation.
2.3 | Randomization
After enrolment (MW), the participants were randomly allocated to
CABB group or ABB group, in a 1:1 allocation ratio. Randomization
was conducted using a computer-generated permuted block randomi-
zation sequence with block sizes of 4. There was no stratification, and
allocation was concealed by sealed, identical, sequentially numbered,
opaque envelopes. Random sequence generation and allocation con-
cealment were performed by an independent staff member who was
not involved in the trial. After every four enrolled participants, four
sealed envelopes were opened in their numerical order. The partici-
pants and the researchers involved in the treatment delivery were
aware of the treatment allocation, while the outcome assessor
(YL) and data analyst (ZS) were blinded to the treatment allocation.
2.4 | Intervention
At 3 months before surgery, smokers were required to quit smoking
until the delivery of the final prosthesis. All the ridge augmentation
procedures were performed by the same experienced surgeon (AM).
On the day of surgery, the participants received 2000 mg
amoxicillin—a prophylactic oral antibiotic—1 h before surgery. One of
the following ridge augmentation procedures was performed.
2.4.1 | CABB group
In this group, bone blocks were digitally designed based on the Digital
Image Communications in Medicine (DICOM) data sets of pre-
operative CBCT scans using Mimics software (version 20.0, Material-
ise, Leuven, Belgium). The technique aims at reconstructing an ideal
alveolar contour and ensuring enough bone for implant placement.
Then the design files were sent to the company (Osteolink Biomaterial
Co., Ltd., Wuhan, China) where CABBs were milled from pre-cut corti-
cocancellous freeze-dried allogeneic bone blocks (the pre-cut alloge-
neic bone block was taken from the iliac crest and its dimension was
20  15  12 cm) using a computer numerical control milling process.
After cleaning, packaging, and sterilization, the CABBs were sent to
the surgeon. A mid-crestal incision was performed with one or two
vertical releasing incisions following local anaesthesia. The mucoper-
iosteal flap was carefully elevated, followed by a periosteal releasing
incision to ensure tension-free primary closure. Cortical perforation
was prepared in the recipient sites. After being rehydrated with sterile
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WANG ET AL. 25

F I G U R E 1 (a, b) Customized
allogeneic bone blocks were
virtually designed based on the
pre-operative cone-beam
computed tomography (CBCT).
(c) Bone defect could be
observed. (d, e) Bone blocks were
fixated on the defect area. (f)
Occlusal view of the augmented
hard tissue at 6 months.
(g) Radiographic view of pre-
operative CBCT. (h) Radiographic
view of CBCT immediately after
wound closure. (i) Radiographic
view of CBCT at 6 months

F I G U R E 2 (a) Autogenous
bone block was harvested from
the external oblique line of the
mandible. (b) Bone defect could
be observed. (c) Bone block was
fixated on the defect area.
(d) Labial view of the augmented
hard tissue at 6 months.
(e) Radiographic view of pre-
operative cone-beam computed
tomography (CBCT). (f)
Radiographic view of CBCT
immediately after wound closure.
(g) Radiographic view of CBCT at
6 months

0.9% saline solution, CABBs were placed on the recipient bed and fix-
ated by titanium pins (8 mm long, 1.5 mm diameter, MatrixMIDFACE,
Depuy Synthes, Warsaw, IN) (Figure 1).
2.4.2 | ABB group
In this group, ABBs were harvested from the external oblique line of
the mandible. At the donor site, an intrasulcular incision and two verti-
cal incisions were performed in the molar area. The mucoperiosteal
flap was then raised to expose the external oblique line of the mandi-
ble. ABBs were retrieved by making osteotomy lines with a
piezosurgery device (Woodpecker, Guilin Woodpecker Medical Instru-
ment Co, Guangxi, China). After completion of osteotomy, the inci-
sions in the donor sites were closed with interrupted sutures (Vicryl,
Ethicon, Somerville, NJ). The surgical procedure for the recipient sites
was similar to that for the CABB group. After flap elevation and corti-
cal perforation, ABBs were adapted to the recipient bed and fixed
with titanium pins (Figure 2).
After the fixation of the CABBs or ABBs, the void surrounding
the bone blocks was filled with particulate bone substitutes (bone
allograft, Osteolink Biomaterial Co., Ltd.). The bone grafts were cov-
ered with a collagen membrane (Bio-Gide, Geistlich Pharma AG, Wol-
husen, Switzerland), while the soft tissue closure was achieved with a

26
horizontal mattress and single interrupted sutures (Prolene, Ethicon).
The participants took amoxicillin antibiotic (500 mg three times a day
for 3 days) and analgesic (diclofenac sodium 50 mg two times a day
for 3 days) and were instructed to rinse with 0.12% chlorhexidine
twice daily for 2 weeks. The sutures were removed at 2 weeks post-
operative. The patients were recalled for follow-up visits 2 weeks,
3 months, and 6 months post-surgery. Complications such as wound
dehiscence and infection were recorded.
2.5 | Outcome evaluation
2.5.1 | Clinical evaluation
During the surgery, the time to obtain and fix the CABBs or ABBs was
recorded and defined as block-related operative time. In the CABB
group, the block-related operative time refers to the time between open-
ing the package of the blocks and fixating the bone blocks. In the ABB
group, the block-related operative time refers to the time of harvesting
blocks from the donor site, trimming the blocks, and fixating the blocks.
Patients were recalled for follow-up visits 2 weeks, 3 months, and
6 months post-surgery. Complications such as bone block exposure
and infection were recorded. Post-operative pain was recorded with a
numerical rating scale (NRS) at suture removal, while NRS was rated
on a score from 0 (“no pain”) to 10 (“worst possible pain”)
(Williamson & Hoggart, 2005). In addition, complications such as
wound dehiscence and infection were recorded.
2.5.2 | Radiographic evaluation
CBCT scans were taken before surgery (T0), immediately after wound
closure (T1), and 6 months after surgery (T2) under the same projec-
tion condition (3DAccuitomo 170, J. Morita Mfg. Corp., Kyoto, Japan).
The images were acquired under the following protocol: acceleration
voltage, 90 kV; beam currency, 5 mA; acquisition time: 17.5 s; FOV
diameter, 140 mm; FOV height, 100 mm; and voxel size, 0.25 mm.
Before surgery, a digital diagnostic wax-up that simulated the
virtual teeth was made based on the pre-operative intraoral scan,
and the long axis of the virtual teeth was the reference line for the
measurements. The standard tessellation language (STL) file of digital
wax-up was imported to an implant planning software (Simplant Pro
17.01, Dentsply Sirona, Lancaster, PA) and superimposed above the
3D model generated from the DICOM files of the pre-operative
CBCT images. At 6 months, the DICOM files of the CBCT images at
T1 and T2 were reconstructed as 3D models and exported as STL
files using the implant planning software. During the 3D reconstruc-
tion process, the threshold value was carefully selected until the con-
tour of the 3D models was identical to the outline of the alveolar
ridge. Thereafter, the STL files of CBCT scans at T1 and T2 were
superimposed on the 3D model of the CBCT scan at T0 based on
anatomical structures, such as the anterior nasal spine and the naso-
palatine foramen. The superimposition process was in accordance
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WANG ET AL.
with a previously described method (Jiang et al., 2018). In addition,
the bucco-oral cross-sectional image perpendicular to the long axis
of the virtual tooth was selected for radiographic measurements
(Figure 3).
The following indices were measured or calculated:
• Ridge width (RW): At each time point (T0, T1, and T2), RW was mea-
sured at five levels (1, 2, 3, 4, and 5 mm apical to the alveolar ridge
crest: RW1–RW5).
• Horizontal bone gain (HBG): At each level (RW1–RW5), the differ-
ence between RW at T2 and RW at T0 was calculated and
expressed as HBG1–HBG5.
• Horizontal bone resorption (HBR): At each level (RW1–RW5), the dif-
ference between RW at T2 and RW at T1 was calculated and
expressed as HBR1–HBR5.
• Horizontal bone resorption rate (HBRR): At each level (RW1–RW5),
HBRR was calculated according to the following formula:
HBRR = (RW at T1 RW at T2)/(RW at T1 RW at T0) and
expressed as HBRR1–HBRR5.
• Vertical bone gain (VBG): The distance between the alveolar ridge
crest at T2 and T0.
• Vertical graft gain (VGG): The distance between the alveolar ridge
crest at T1 and T0。.
• Vertical bone resorption (VBR): The distance between the alveolar
ridge crest at T2 and T1。.
• Vertical bone resorption rate (VBRR): VBRR was calculated according
to the following formula: VBRR = VBR/(VGG).
An experienced, calibrated, and blinded assessor (LY) performed
all measurements, which were repeated twice and then averaged. In
cases of multiple sites per patient, only one site was randomly
selected by the assessor (LY) for measurement, while a drawing lots
method was used for randomization. Ten randomly selected sites
were re-evaluated to assess the intra-observer reliability after a
1-month interval. Intra-class correlation coefficient (ICC) was used to
determine the intra-observer reliability, and an ICC value between .92
and .98 indicated a good agreement on the measurement.
2.5.3 | Histological observation
At 6 months after surgery, re-entry was performed for implant instal-
lation. A cylindrical biopsy specimen was harvested perpendicularly to
the lateral aspect of the bone blocks using a trephine bur. The biopsy
specimen was then taken for haematoxylin and eosin (H&E) staining,
which was used for a general histologic analysis.
2.6 | Outcome variables
The primary outcome was HBG1. Secondary outcomes were HBG2-5,
RW1-5 at each time point, HBRR1-5, VBG, VBRR, block-related oper-
ative time, post-operative pain score, and histological results.
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WANG ET AL. 27

F I G U R E 3 (a, b) Digital diagnostic wax-up of the virtual teeth was made based on the pre-operative intraoral scan. (c) Standard tessellation
language (STL) file of digital wax-up was superimposed above the 3D model generated from the Digital Image Communications in Medicine
(DICOM) files of the pre-operative cone-beam computed tomography (CBCT) images. (d) DICOM files of the post-operative CBCT scans at T1
(red) and T2 (white) were converted to STL files respectively and superimposed on the pre-operative CBCT (yellow). (e) Bucco-oral cross-sectional
image perpendicular to the long axis of the virtual tooth was selected for radiographic measurements. Yellow line: The outline of the hard tissue
before surgery (T0); red line: The outline of the hard tissue after wound closure (T1); white line: The outline of the hard tissue at 6 months (T2).
The distance between the alveolar ridge crest at T1 and the alveolar ridge crest at T0 was measured as vertical graft gain. The distance between
the alveolar ridge crest at T2 and the alveolar ridge crest at T0 was measured as vertical bone gain. (f) Ridge width (RW) was measured at 1, 2,
3, 4 m, and 5 mm (RW1–RW5) apical to the alveolar ridge crest at each time point (e.g., the distance between points “A” and “B” was RW1 at T0).

2.7 | Sample size calculation • Allocation ratio: 1:1.

In this study, HBG1 was considered as the primary outcome. The
objective of the analysis was to test whether there were significant
differences in the HBG1 between the two groups. Thus, the following
hypotheses were adopted: H0—there was no difference in the HBG1
between the CABB group and the ABB group; H1—there was a differ-
ence in the HBG1 between the CABB group and the ABB group.
The following variables were used in the sample size calculation:
• Drop-out rate: 10%.
PASS software (PASS 15, NCSS, LLC., Kaysville, UT) was used
for sample size calculation. Considering a 10% drop-out rate, a
sample size of 24 participants (12 participants per group) was
required to achieve 80% power to reject the null hypothesis of
equal means with a significance level of .05 using a two-sided two-
sample t-test.

• Clinical relevant difference (δ): set at 2 mm (Schwarz et al., 2018).

• Assessing SD: According to the study by Kloss et al. (2018), the SD 2.8 | Statistical analysis
of the allogeneic bone block group and ABB group was 1.4 and
1.6 mm, respectively. Statistical analyses were performed using SPSS 20.0 software (IBM
• Type I error: α = .05. Company, Armonk, NY). The data were summarized by descriptive sta-
• Type II error: β = .20. tistics, while quantitative data were reported as means ± SD. Shapiro–
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28 WANG ET AL.

F I G U R E 4 Flow diagram.
ABB, autogenous bone block;
CABB, customized allogeneic
bone block

TABLE 1 Descriptive statistics for

CABB ABB p Values
each group
Male/female 6/6 4/8 .680
Mean age ± SD 38.67 ± 15.20 29.83 ± 8.61 .098
Site .478
Incisive 10 12
Premolar 1 0
Molar 1 0
Smoke/no smoke 2/10 1/11 1.000
Mean missing teeth at defect ± SD 2.58 ± 1.00 2.25 ± 1.22 .514
With/Without vertical bone defect 7/5 5/7 .684
Bone block width 15.72 ± 7.79 12.76 ± 5.90 .306

Abbreviations: ABB, autogenous bone block; CABB, customized allogeneic bone block.

TABLE 2 Results of bone gain for each group (mean ± SD [lower 95% CI, upper 95% CI], mm)

CABB ABB Mean difference p Values

HBG1 4.29 ± 1.48 (3.34, 5.23) 1.12 ± 3.25 ( 0.95, 3.19) 3.16 ± 1.03 (1.02, 5.31) .008a
HBG2 3.94 ± 1.50 (2.98, 4.89) 2.25 ± 2.80 (0.46, 4.03) 1.69 ± 0.92 ( 0.21, 3.59) .079
HBG3 4.30 ± 1.07 (3.61, 4.98) 2.68 ± 2.23 (1.26, 4.10) 1.62 ± 0.71 (0.13, 3.10) .034a
HBG4 4.13 ± 1.13 (3.42, 4.85) 3.12 ± 2.19 (1.73, 4.51) 1.01 ± 0.71 ( 0.49, 2.52) .173
HBG5 3.86 ± 1.53 (2.89, 4.83) 3.28 ± 1.42 (2.38, 4.18) 0.58 ± 0.60 ( 0.67, 1.83) .346
VBG 1.38 ± 1.54 (0.40, 2.36) 0.54 ± 1.83 ( 0.62, 1.71) 0.84 ± 0.69 ( 0.59, 2.27) .238

Abbreviations: ABB, autogenous bone block; CABB, customized allogeneic bone block; CI, confidence interval; HBGx, horizontal bone gain at x mm apical
to the alveolar ridge crest; VBG, vertical bone gain.
a
Statistically significant.
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WANG ET AL. 29

Wilk test was used to test normality. Longitudinal data were analysed

Values
.001a
.004a
.002a
.013a
.002a
with a generalized linear mixed effects model. RW1–5 were considered

p
as the dependent variable. Groups, time (T0–T2), and groups * time

3.52 ± 3.23 (1.47, 5.58)

5.76 ± 2.41 (4.22, 7.29)
7.05 ± 1.42 (6.15, 7.96)
7.96 ± 1.42 (7.06, 8.86)
8.33 ± 1.05 (7.66, 9.00)
interaction were considered as fixed factors, while patient effects were
modelled as random effects. The variance components type covariance
structure was determined to provide the best covariance model fit

Mean ± SD (lower 95% CI, upper 95% CI)

based on the Akaike information criterion and Bayesian information cri-
terion. Planned contrasts were used to compare the two groups at each

Abbreviations: ABB, autogenous bone block; CABB, customized allogeneic bone block; CI, confidence interval; RWx, the ridge width measured x mm apical to the alveolar ridge crest.
ABB

time point. p Values were adjusted for multiple comparisons using the
Bonferroni method. For statistical comparisons of the other data, a
6 Months after surgery (T2)

9.45 ± 1.27 (8.64, 10.25)

10.00 ± 1.28 (9.19, 10.82)
6.76 ± 1.11 (6.05, 7.47)
8.06 ± 0.99 (7.43, 8.69)
8.88 ± 1.09 (8.19, 9.57) two-sample t-test was used for data with a normal distribution, while a
Mann–Whitney U-test was used for data with non-normal distribution.
The statistical test level was set as .05.
CABB

3 | RE SU LT S

3.1 | Patients
Values
.007a
.021a
a

.038a
a
.015

.017
p

The flow of the participants throughout the study is presented in

9.42 ± 1.45 (8.49, 10.34)
9.80 ± 1.26 (9.00, 10.60)
9.89 ± 1.05 (9.22, 10.55)
8.24 ± 1.63 (7.21, 9.28)
8.94 ± 1.54 (7.96, 9.92)

Figure 4. A total of 24 participants were included in this study (12 in

the CABB group and 12 in the ABB control group). Three participants
in the CABB group received bone grafting with two blocks due to
their large bone defects, while other participants received only one
Mean ± SD (lower 95% CI, upper 95% CI)

block. No patients dropped out during the follow-up period. Patient

Results of the ridge width at each time point (mean ± SD [lower 95% CI, upper 95% CI], mm)

ABB

demographics and the characteristics of the augmented sites for each

Immediately after surgery (T1)

group are shown in Table 1. There were no statistically significant dif-

11.25 ± 1.73 (10.15, 12.35)

ferences existed between the two groups.

9.73 ± 0.94 (9.13, 10.33)
10.35 ± 1.32 (9.51, 11.18)
10.88 ± 1.57 (9.88, 11.88)
11.06 ± 1.69 (9.98, 12.13)

3.2 | Primary outcome

Data on the HBG1 are shown in Table 2. Mean HBG1 was 4.29
CABB

± 1.48 mm in the CABB group and 1.12 ± 3.25 mm in the ABB group
(p = .008). The mean difference between the two groups at HBG1
Values

was 3.16 mm (95% CI 1.02–5.31 mm).

.811
.257
.736
.492
.099
p

2.40 ± 0.64 (1.99, 2.81)

3.51 ± 1.01 (2.87, 4.15)
4.37 ± 1.44 (3.45, 5.29)
4.84 ± 1.44 (3.92, 5.75)
5.05 ± 1.19 (4.29, 5.81)

3.3 | Secondary outcomes

Mean ± SD (lower 95% CI, upper 95% CI)

3.3.1 | Clinical outcomes

ABB

Our data showed that the block-related operative time in the ABB
group (mean ± SD: 78.50 ± 7.50 min) was significantly longer than the
2.48 ± 0.78 (1.98, 2.97)
4.13 ± 1.40 (3.24, 5.02)
4.58 ± 1.26 (3.78, 5.38)
5.31 ± 1.70 (4.23, 6.39)
6.15 ± 1.68 (5.08, 7.22)

time in the CABB group (mean ± SD: 8.75 ± 4.49 min; p < .001). The
Before surgery (T0)

mean difference between the two groups at the block-related opera-

tive time was 69.75 min (95% CI 74.96 to 64.53 min). In addi-
Statistically significant.

tion, the post-operative pain score in the ABB group was 5.83 ± 1.59,
while that in the CABB group was 5.42 ± 1.93 (p = .596).
CABB

On the other hand, the soft tissue healing was uneventful in

TABLE 3

23 patients without any signs of infection or graft exposure. However,

RW1
RW2
RW3
RW4
RW5

bone block exposure was observed in one patient in the CABB group
at 3 months. The patient received bone grafting with two bone blocks,
a
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30 WANG ET AL.

TABLE 4 Results of bone resorption for each group (mean ± SD [lower 95% CI, upper 95% CI], %)

CABB ABB Mean difference p Values

HBR1 2.97 ± 0.78 (2.48, 3.46) 4.72 ± 2.16 (3.35, 6.09) 1.75 ± 0.66 ( 3.17, 0.33) .015a
HBR2 2.28 ± 1.14 (1.56, 3.01) 3.19 ± 2.02 (1.90, 4.47) 0.91 ± 0.67 ( 2.30, 0.51) .191
HBR3 2.00 ± 1.08 (1.32, 2.69) 2.37 ± 1.50 (1.41, 3.32) 0.36 ± 0.53 ( 1.47, 0.75) .506
HBR4 1.61 ± 1.07 (0.93, 2.29) 1.84 ± 1.53 (0.87, 2.82) 0.23 ± 0.54 ( 1.35, 0.89) .673
HBR5 1.24 ± 1.09 (0.55, 1.93) 1.56 ± 1.02 (0.91, 2.20) 0.32 ± 0.43 ( 1.21, 0.57) .467
VBR 1.77 ± 0.95 (1.17, 2.37) 2.19 ± 0.90 (1.62, 2.76) 0.42 ± 0.38 ( 1.20, 0.36) .278

Abbreviations: ABB, autogenous bone block; CABB, customized allogeneic bone block; CI, confidence interval; HBRx, horizontal bone resorption at x mm
apical to the alveolar ridge crest; VBR, vertical bone resorption.
a
Statistically significant.

TABLE 5 Results of bone resorption rate for each group (mean ± SD [lower 95% CI, upper 95% CI], %)

CABB ABB Mean difference p Values

HBRR1 42.15 ± 14.03 (33.23, 51.06) 92.52 ± 55.78 (57.08, 127.96) 50.37 ± 16.60 ( 86.42, 14.32) .010a
HBRR2 36.81 ± 16.32 (26.44, 47.18) 65.40 ± 47.59 (35.16, 95.63) 28.59 ± 14.52 ( 58.70, 1.53) .068
HBRR3 31.18 ± 14.78 (21.79, 40.57) 50.44 ± 32.76 (29.63, 71.26) 19.26 ± 10.38 ( 40.78, 2.26) .077
HBRR4 26.78 ± 16.40 (16.36, 37.20) 39.37 ± 29.86 (20.40, 58.35) 12.59 ± 9.84 ( 32.99, 7.81) .214
HBRR5 23.30 ± 23.87 (8.13, 38.47) 32.02 ± 19.60 (19.57, 44.47) 8.72 ± 8.92 ( 27.21, 9.77) .339
VBRR 65.76 ± 42.42 (38.81, 92.71) 108.12 ± 77.25 (59.04, 157.20) 42.36 ± 25.44 ( 96.01, 11.29) .114

Abbreviations: ABB, autogenous bone block; CABB, customized allogeneic bone block; CI, confidence interval; HBRRx, horizontal bone resorption rate at x
mm apical to the alveolar ridge crest; VBRR, vertical bone resorption rate.
a
Statistically significant.

F I G U R E 5 Histological view of the augmented hard tissue at 6 months (haematoxylin and eosin). (a, b) Representative histologic sample of
the cortical bone layer of allogeneic bone blocks. Only a small amount of vital bone (VB) was surrounded by the non-vital bone (NVB). (c, d)
Representative histologic sample of the cancellous bone layer of allogeneic bone blocks. New bone (VB) was in direct contact with residual
allografts (NVB), while new blood vessels could be observed. (e, f) Representative histologic sample of the autogenous bone blocks. New bone
(VB) could be observed in the inner portion of the graft (NVB).

and the anterior bone block was found to be exposed and thus
removed immediately. The soft tissue healed completely and there
were no signs of infection or exposure in the posterior bone block
during the 6-month follow-up period. The remaining bone block was
used for radiographic evaluation.
3.3.2 | Radiographic outcomes
The results of the RW at each time point are shown in Table 3.
No statistically significant difference existed in RW1–5 at T0 between
the groups (p > .05). At T1 and T2, the CABB group showed

WANG ET AL.
significantly greater ridge width at RW1–5 compared with the ABB
group (p < .05).
In addition, bone gain, bone resorption, and bone resorption rate
are summarized in Tables 2, 4, and 5. The CABB group showed signifi-
cantly greater bone gain at HBG3 (p = .034), while no significant differ-
ence was detected between the two groups at HBG2,4,5 (p > .05). In
terms of bone resorption, the mean HBR1 was 2.97 ± 0.78 mm in the
CABB group and 4.72 ± 2.16 mm in the ABB group, and the difference
between the groups was statistically significant (p = .015). Comparable
outcomes were also noted in bone resorption rate: the HBRR1
amounted to 42.15% (SD: 14.03%) in the CABB group and 92.52%
(SD: 55.78%) in the ABB group (p = .010). Moreover, the mean VGG
was 3.15 ± 1.23 mm in the CABB group and 2.73 ± 1.28 mm in the
ABB group (p = .414), while mean VBG was 1.38 ± 1.54 in the CABB
group and 0.54 ± 1.83 mm in the ABB group (p = .238).
3.3.3 | Histological observation
Representative histological sections of the augmented hard tissue at
6 months from each group are shown in Figure 5. The augmented
hard tissue was classified as non-vital bone characterized by the
presence of empty bone lacuna and vital bone characterized by the
presence of osteocytes. In the CABB group, non-vital bone formed
the major portion of the cortical bone layer of allogeneic bone
blocks, while only a small amount of vital bone was surrounded by
the non-vital bone. In the cancellous bone layer of the allogeneic
bone blocks, there was formation of a large number of new bone and
blood vessels around the bone meshwork of the allograft. The histo-
logic appearance of the ABB groups showed similar results with the
cortical bone layer of allogeneic bone blocks. In addition, the H&E
staining demonstrated the formation of a small amount of new bone
in the transplanted bone. No signs of inflammation were observed in
both groups.
4 | DISCUSSION
The null hypothesis of the study was rejected. The present study
showed that (a) CABBs led to more HBG and less HBR at 1 mm below
the alveolar ridge crest compared with ABBs; (b) ridge augmentation
with CABBs was associated with shorter operating time compared
with ABBs.
Nowadays, the use of digital technology is changing the applica-
tion of conventional bone augmentation procedures. Various digital
bone augmentation techniques, such as pre-bent titanium mesh,
3D-printing or CAD-CAM-produced titanium mesh, and customized
bone block, could help in virtually designing the augmented hard tis-
sue based on the future prosthetic outcome, achieve a more precise
ridge augmentation, and significantly reduce the surgical time (Sagheb
et al., 2017; Al-Ardah et al., 2018; Blume et al., 2018; Ciocca
et al., 2018; Li et al., 2021). While the experience and surgical skills of
the dentist can also assist to implement successful ridge
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31
augmentation, the decrease in the surgical time was a prominent
advantage associated with digital bone augmentation techniques. As
the ridge augmentation procedure was complex, the block-related
operative time was used in this study to avoid the effects of other
steps on the surgical time. Our study demonstrated that the CABBs
shortened the surgical time. Besides, the block-related operative time
in the CABB group was significantly shorter compared with that in the
ABB group (8.75 ± 4.49 min in the CABB group vs. 78.50 ± 7.50 min
in the ABB group). This may be ascribed to the fact that there was no
need to harvest and trim bone blocks in the CABB group.
The application of block-form bone grafts is often associated
with soft tissue complications, leading to poor outcomes of bone
augmentation procedures. Chaushu et al. (2019) reported a high soft
tissue complication rate, including soft tissue perforation (12.5%),
incision line opening (80%), and block exposure (25%), following the
application of cancellous allogeneic bone blocks for reconstruction
of the anterior atrophic mandible. Another clinical study on autoge-
nous onlay grafting technique showed flap dehiscence and graft
exposure in five of eight patients within the first post-operative
month (El et al., 2019). By contrast, several studies reported a very
low soft tissue complication rate with the use of ABBs or allogeneic
bone blocks (Kloss et al., 2018; Thoma et al., 2018). In the present
study, graft exposure was observed in only one patient in the CABB
group at 3 months post-surgery, while apical periodontitis in the
adjacent teeth was found at the first month and might be a potential
cause of graft exposure. In addition, there was no soft tissue compli-
cation in other patients in both groups. The achievement of good
soft tissue management might be a critical factor in the prevention
of soft tissue complications. Surgeons with sufficient experience in
bone augmentation may contribute to the reduction of the incidence
of complications (Urban et al., 2021).
Although donor site morbidity was a major drawback of ABBs, no
donor site complication, except local swelling, was observed in the
ABB group. This may be due to the selection of the external oblique
line of the mandible as the donor site, which was remote from vital
anatomical structures. A previous systematic review demonstrated
that the mandible ramus was associated with the lowest donor site
complication rates compared with other sites (Scheerlinck
et al., 2013). In this study, patients in both groups had a similar level
of post-operative pain scores. Our results were consistent with previ-
ous findings found in a randomized controlled clinical trial that com-
pared xenogeneic block with ABBs (Thoma et al., 2018). This could be
due to the low donor site morbidity in the ABB group and the use of
post-operative analgesics.
Recently, the allogeneic bone blocks have been gradually utilized
in ridge augmentation. Several studies have reported that the success
rates of the blocks are in the range of 94.7%–100% (Nissan
et al., 2008; Barone et al., 2009; Carinci et al., 2010; Dahlin &
Johansson, 2011; Pereira et al., 2015). A recent systematic review
demonstrated that the implant survival rates in allogeneic bone blocks
(96.23 ± 5.27%) were similar to those of ABBs (97.66 ± 2.68%)
(Donkiewicz et al., 2021). A study conducted concerning bone gain
and resorption using allogeneic bone blocks by Kloss et al. (2018)

32
reported a mean HBG of 5.2 ± 1.4 mm and a mean VBG of 0.2
± 1.2 mm. Elsewhere, a previous systematic review reported that the
mean HBG of allogeneic bone blocks from 119 sites was 4.79 mm,
whereas the bone resorption rates ranged from 10 ± 10% to 52
± 25.97% (Monje et al., 2014). Notably, the results of allogeneic bone
blocks obtained in this study were in consonance with the reported
findings of several previous studies. In the present study, RW1–5 at
baseline was similar in the two groups (CABB and ABB), indicating a
good between-group comparability. Nevertheless, the CABB group
showed significantly more horizontal bone gain and less bone resorp-
tion at 1 mm below the alveolar ridge crest compared with that of the
ABB group (HBG1: CABB group [4.29 ± 1.48 mm] and ABB group
[1.12 ± 3.25 mm]; HBRR1: CABB group [42.15 ± 14.03%] and ABB
group [92.52 ± 55.78%]). The differences between the two groups,
where the corticocancellous allogeneic bone blocks and cortical ABBs
were compared in the present study, could have been contributed by
the difference in the microarchitecture of the grafts.
Vascularization is considered an important process that supports
bone remodelling and repair (Das & Botchwey, 2011). It has been
reported that the sponge-like structure of cancellous bone can allow
faster vascularization and more active bone remodelling compared
with cortical bone (Wilson et al., 1985; Enneking & Mindell, 1991).
Furthermore, this had been shown through histological evidence. A
previous study compared the histological outcomes of different bone
blocks (Spin-Neto et al., 2015), and the histomorphometric analyses in
the study showed a mean of 3.9%, 83.7%, and 12.3% for vital bone,
non-vital bone, and soft tissue, respectively, in augmented cortical
allogeneic bone blocks. Elsewhere, Chaushu et al. (2019) reported a
mean of 42%, 17%, and 41% for vital bone, non-vital bone, and soft
tissue, respectively, in augmented cancellous allogeneic bone blocks.
Histomorphometric analyses in another randomized controlled trial
showed a mean of 14%, 80%, 5%, and 1% for vital bone, non-vital
bone, soft tissue, and blood vessels, respectively, in the augmented
autogenous cortical bone (Hartlev et al., 2020). Notably, the histologi-
cal findings of this study were also consistent with the described
results in the previous studies.
It was evident that the cancellous bone was more vulnerable to
bone resorption in the early healing period, which could be due to
high active bone-remodelling process. A randomized clinical trial
showed a higher bone resorption rate with cancellous allogeneic
block grafts (29.2 ± 2.6%) compared with corticocancellous alloge-
neic block grafts (19.3 ± 2.3%) (Tresguerres et al., 2019). On the
other hand, the highly dense cortical bone could also have led to
more bone resorption in the late healing period. A separate study
conducted by Cha et al explored the impact of perforating the autog-
enous block bone on the bone-remodelling process in an animal
model (Cha et al., 2012). The findings of the study showed that the
non-perforated autogenous blocks maintained their original struc-
ture with higher osteoclastic activity during the late healing period,
whereas the new bone formation was observed over the entire per-
forated autogenous blocks. In a 10-year prospective clinical study,
the autogenous blocks from the ramus, which have a thicker cortical
bone, showed more resorption than the blocks from the chin
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WANG ET AL.
(Chappuis et al., 2017). Therefore, it is evident that the corticocan-
cellous bone blocks can take advantage of both cortical bone and
cancellous bone. Furthermore, the cancellous layer could provide a
scaffold for the formation of new blood vessels and bone, whereas
the cortical layer could serve as a barrier to resist external pressure
and prevent bone resorption in the early healing period.
Concerning the research methods, some limitations have to be
addressed. The first limitation was that the study was single-blinded
and not triple-blinded. Due to the nature of the intervention and the
presence of donor sites in the ABB group, the surgeon and partici-
pants cannot be blinded to the treatment allocation. Therefore, most
outcomes of this study were evaluated by objective outcome indica-
tors to minimize bias. Further, standardization and training for the
outcome assessor were performed before the start of the study to
minimize the measurement error, and there was no ICC value, for
the measurements was less than 0.90 in the current study, which
indicates excellent reliability and repeatability. Moreover, the out-
come assessor was blinded to minimize the risk of detection bias. As
mentioned above, the difference in the microstructure of CABBs and
ABBs might have an impact on the new bone formation process, and
it should be considered as a limitation of this study. Another possible
weakness of this study was that all radiographic measurements were
performed only in a 2D cross-sectional image. However, the findings
of the current study could provide useful guidance for clinical prac-
tice because most clinicians are familiar with 2D results. Finally, the
present study had a short follow-up period of only 6 months and a
small sample size. As the sample size calculation was based on the
primary outcome, the study is probably underpowered for inference
on any measurements other than the primary outcome. Therefore,
the results of the present study must be interpreted conservatively,
and future long-term, large-sample randomized controlled clinical tri-
als should be conducted to support and confirm the results of the
present study.
5 | CONC LU SION
Within the limitations of this study, it can be concluded that the use
of CABBs could result in more HBG and less HBR at 1 mm below the
alveolar ridge crest at 6 months post-surgery compared with ABBs
while reducing the operative time.
AUTHOR CONTRIBU TIONS
Maoxia Wang was involved in conceptualization, methodology, and
writing—original draft preparation. Yazhen Li was involved in soft-
ware, investigation, and data curation. Zhenya Su was involved in data
curation. Anchun Mo was involved in conceptualization, writing—
review and editing, supervision, and project administration. All authors
have read and agreed to the published version of the manuscript.
AC KNOW LEDG EME NT S
This research was funded by the Sichuan Health Research Project
(grant number: 19ZD008) and the Clinical Research Project of West

WANG ET AL.
China Hospital of Stomatology, Sichuan University (grant number:
LCYJ2020-YF-2).
CONF LICT OF IN TE RE ST
The authors declare no conflict of interest.
DATA AVAI LAB ILITY S TATEMENT
The data that support the findings of this study are available on
request from the corresponding author. The data are not publicly
available due to privacy or ethical restrictions.
E TH I CS S T A TE M E N T
The study was conducted according to the guidelines of the Declara-
tion of Helsinki, and approved by the ethical committee of West
China Hospital of Stomatology, Sichuan University (protocol code
WCHSIRB-D-2019-068 and 20 March 2019).
INFORMED CONSENT
Informed consent was obtained from all subjects involved in the
study.
ORCID
Maoxia Wang https://orcid.org/0000-0002-6288-3086
Anchun Mo https://orcid.org/0000-0002-3946-2486
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How to cite this article: Wang, M., Li, Y., Su, Z., & Mo, A.
(2023). Clinical and radiographic outcomes of customized
allogeneic bone block versus autogenous bone block for ridge
augmentation: 6 Month results of a randomized controlled
clinical trial. Journal of Clinical Periodontology, 50(1), 22–35.
https://doi.org/10.1111/jcpe.13714