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A Multilevel Analysis of Platform-Switching

Flapless Implants Placed at Tissue Level:


4-year Prospective Cohort Study
Carlo Prati, MD, DDS, PhD1/Fausto Zamparini, DDS, MEndo, PhD2/Chiara Pirani, DDS, MEndo, PhD1/
Lucio Montebugnoli, MD, DDS3/Luigi Canullo, MD, DDS4/Maria Giovanna Gandolfi, DBiol, MBiol, PhD2

Purpose: To evaluate the factors affecting peri-implant marginal bone level of single platform-switched
implants with a smooth neck placed at gingival level (tissue level) using a flapless technique. Materials and
Methods: Consecutive healthy patients requiring dental implant rehabilitations were enrolled in this study.
Titanium implants with a zirconium-oxide–blasted surface and a platform-switch neck tulip configuration were
used. Loading was performed 3 months after insertion with a provisional resin crown and after approximately
15 days with a definitive ceramic crown. Peri-implant marginal bone level (MBL) was measured on periapical
radiographs at 1, 3, 6, 12, 24, 36, and 48 months by a blinded assessor. The following parameters were
evaluated: location (maxillary/mandibular), position (anterior/posterior), sex (male/female), smoke (yes/no),
implant placement timing (immediate, early, delayed), gingival thickness (thin/thick), endodontically treated
adjacent teeth (yes/no), and diameter (3.8/4.25/5.0 mm). Multilevel analyses exploring factors associated
with MBL at 36 and 48 months were performed. Results: A total of 76 patients (42 women, 34 men; mean
age: 55.6 ± 10.7 years) received 128 implant rehabilitations. The survival rate was 98.4%. MBL displayed
an initial increase during the first months from insertion (preload period). Cumulative mean MBL at T48 was
0.99 ± 0.68, which was not statistically significant from the values at T24 to T36 (P > .05). Mandibular location,
delayed implants, and presence of adjacent endodontically treated teeth showed higher bone loss at 36
months (P < .05). Interestingly, at 48 months, only implant placement timing showed statistically significant
differences. Delayed implants showed increased bone loss compared with both early and immediate groups
(P < .05). Multilevel analysis confirmed the statistical significance of implant location (P = .031; 95% CI: 0.031
to 0.659), endodontically treated adjacent teeth (P = .001; 95% CI: –1.228 to 0.859), and implant placement
(P = .045; 95% CI: 0.003 to 0.337) as factors affecting MBL at 36 months. All the investigated parameters, with
the only exception being the implant placement group (P = .020; 95% CI: 0.334 to 1.432), were not statistically
significant at 48 months (P > .05). Conclusion: Platform-switched implants placed nonsubmerged with a
flapless approach showed a reduced bone loss progression in the first 4 years, as MBL remained stable at
longer times (36 and 48 months). Implants placed with early and immediate timing showed reduced bone loss
compared with delayed implants. Int J Oral Maxillofac Implants 2020;35:330–341. doi: 10.11607/jomi.7541

Keywords: best clinical practice, dental implants, flapless surgery, MBL, platform-switch

A lthough submerged dental implants show high


1Endodontic Clinical Section, School of Dentistry, Department
of Biomedical and Neuromotor Sciences, University of and predicable long-term success,1,2 a grow-
Bologna, Bologna, Italy. ing interest in less-invasive protocols has been re-
2Endodontic Clinical Section, School of Dentistry, Department

of Biomedical and Neuromotor Sciences, University of


ported in the literature. 3 Placement of implants in a
Bologna, Bologna, Italy; Laboratory of Biomaterials and Oral nonsubmerged tissue-level approach has been pro-
Pathology, School of Dentistry, Department of Biomedical and posed in different studies as a predictable technique
Neuromotor Sciences, University of Bologna, Bologna, Italy. with similar risks compared with the traditional sub-
3Oral Sciences Section, School of Dentistry, Department of
merged technique4–6 and high long-term survival.7
Biomedical and Neuromotor Sciences, University of Bologna,
Bologna, Italy.
Nonsubmerged healing is usually achieved placing
4Private Practice, Rome, Italy. a bone-level implant and immediately positioning
a healing screw, which remain exposed to the oral
Correspondence to: Prof Carlo Prati, Via San Vitale 59, 40125 environment.8
Bologna, Italy. Fax +39-051-225208. Email: carlo.prati@unibo.it The platform-switching concept was reported
by Lazzara and Porter in 2006.9 Through the repo-
Submitted December 22, 2018; accepted October 9, 2019.
sitioning of a cylindrical implant-abutment junc-
©2020 by Quintessence Publishing Co Inc. tion far from the crestal bone, platform switching

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Prati et al

demonstrated reduced bone loss values.9,10 Implants MATERIALS AND METHODS


with this configuration are usually positioned at bone
level (submerged), with the neck at crestal bone height Study Setting and Patient Selection
(equicrestally) or under (subcrestally).5,8,11,12 The study design was a single-blind human longitu-
Platform-switched implants with a moderate tulip- dinal prospective cohort study comparing the clinical
shaped neck were tested in a recent study12 in an and radiographic outcomes after 4 years for the treat-
equicrestal position with a transmucosal healing screw ment of patients who had lost one or more teeth due
with reduced marginal bone loss at 24 months. to endodontic, root fracture, and deep-carious lesions.
Histologic findings, however, revealed that when The study was conducted in one University End-
tapered platform-switched implants are positioned odontic Clinical Department and in two private den-
subcrestally, greater bone remodeling occurs, as the tal offices between January 2011 and June 2018 by
removal of a great portion of the coronal bone during the same clinical team. Recruitment of patients was
site preparation compromises blood supply of the re- performed from October 2009 to June 2014. Once in-
maining cortical bone.13,14 cluded in the study, patients were treated from Janu-
In this context, factors such as implant-abutment ary 2010 to July 2014.
connection, micromobility, and associated tissue in- All patients included in this investigation were
flammation play an important role in relation to the treated according to the principles established by the
crestal bone remodeling.15 Declaration of Helsinki as modified in 2013.26
Moreover, the placement of a smooth/unroughened Before enrollment, written and verbal information
tulip-shaped–neck implant in a subcrestal position was given by the clinical staff, and each patient gave
was found to not support crestal bone16 and may also a written consent according to the aforementioned
be associated with initial bone loss.17 principles. An additional signed informed consent was
A low-invasive approach could be the placement of obtained from all patients stating that they accepted
a flapless platform-switched implant with a moderate the treatment plan and agreed to cover the costs and
tulip-shaped neck in a supracrestal position.18 follow the maintenance hygiene program. This report
Marginal bone level (MBL) differences represent an was written according to the Consolidated Standards
important analysis that may provide information on of Reporting trials guidelines for reporting clinical
peri-implant bone health/disease.19 Indeed, the ra- trials (STROBE)27 and respecting the guidelines pub-
diographic assessment of MBL at different endpoints lished by Dodson in 2007.28
gives important information regarding the hard and The patients were considered eligible or noneligible
soft tissue modification that occurs in the early heal- for inclusion in the clinical protocol based on the fol-
ing phases (preload period)20,21 or after the definitive lowing criteria:
restoration (postload period).22
Numerous other conditions, as well as preoperative, Inclusion criteria:
intraoperative, and postoperative parameters may • 18 to 75 years of age at the time of implant
affect the peri-implant marginal bone morphology/ placement
environment and clinical-radiographic aspects. • Partially dentate requiring dental implants
Different statistical methodologies, such as mul- • Possibility of being included in a hygiene recall
tilevel analysis23 or linear logistic regressions,24,25 program and implant control for at least 4 years
have been proposed and used to evaluate and cor-
relate strategic-technical (ie, surgical) decisions with Exclusion criteria:
many factors associated with MBL, such as bone qual- • Medical and/or general contraindications for the
ity, implant diameter, implant surface, and type of surgical procedures (ASA score ≥ 3)
prosthesis.24 • Poor oral hygiene and lack of motivation
The aim of this consecutive, nonrandomized • Active clinical periodontal disease in the dentition
prospective cohort study was to investigate fac- expressed by probing pocket depth > 4 mm and
tors that may affect MBL around implants placed bleeding on probing
nonsubmerged. • Smoking more than 20 cigarettes per day29
The primary outcome measures were implant MBL • Uncontrolled diabetes mellitus
variation at 1 and 3 months (preload time) and at 6, 12, • Systemic or local diseases that could compromise
24, 36, and 48 months. postoperative healing and osseointegration
The secondary outcome measures were the success • Alcohol and/or drug abuse
and survival rates of implant rehabilitations after 48 • Pregnancy or lactating
months. • Malocclusion and other occlusal disorder (bruxism)
• Bisphosphonate therapy

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Prati et al

Clinical evaluations of periapical status were made administration continued for 5 to 6 days after
by three experienced operators included as authors surgery.
(C.P., Ch.P., F.Z.). All surgical procedures were conducted under
local anesthesia with mepivacaine chlorhydrate
Treatment Procedures 30 mg/mL (Carboplyina, Dentsply Italia). No computer-
The choice of implant placement timing was per- aided guide was used.
formed following the recommendations proposed by Implants were placed in order to obtain a nonsub-
the Third ITI Consensus Conference. This classification merged tissue-level healing, with the entire rough
was performed aiming to reflect the alveolar hard and surface located in the bone tissue and the smooth
soft tissue modifications occurring from the moment neck surface immersed in gingival tissue (supracrestal
of tooth extraction (Type 1) to the complete matura- placement).
tion of the tissues (Type 4).30 The final insertion torque was measured using the
Three different implant placement timings were W&H Implantmed motor (W&H Dentalwerk Bürmoos)
performed: and recorded. The values ranged between 20 and
70 N/cm2. An adequate primary stability was obtained
• Immediate postextraction implant (Type 1 for in all implants.
ITI)30: when the implant was placed into a fresh The thickness of the mucosa was carefully mea-
extraction socket immediately after extraction of sured with a periodontal probe, and depending on
the root affected by chronic periapical disease and/ this, a 1-mm or 2- to 3-mm-high cover-healing screw
or seriously damaged hopeless (or fractured) teeth. was selected, which emerged just over the gingival
Only chronic periapical lesions were present and level.
identified by periapical radiolucency.
• Early implant (Type 2 for ITI)30: when the implant Immediate Implant Placement
was placed in healed bone after 8 to 12 weeks after For immediate postextractive insertion, an atraumatic
extraction of root affected by acute periapical lesion flapless root extraction was performed, and a careful
and/or abscess, pus, and clinical symptoms inspection of the socket site was made. All granulation
• Delayed implant (Type 4 for ITI)30: when the implant tissue was gently debrided from the apical portion of
was placed in edentulous mature bone 10 to 12 the socket.
months after the tooth extraction for different Then, a 1.2-mm drill was used to prepare the in-
reasons trasocket place, following the palatal bony walls as a
guide. Twist and calibrated drills at 225 rpm were then
Therefore, no randomization was used aiming to used and irrigated with sterile saline solution.
follow the principles of the “best clinical practice.”31 Primary implant stability was obtained by anchor-
ing the implant in the remaining apical portion of the
Surgical Procedures socket at least 3 mm beyond the root apex area.
Cylindrical implants (Premium SP, Sweden & Mar- When necessary (four cases), a porcine corticocan-
tina) with a zirconium-oxide–blasted surface; smooth cellous bone substitute (Osteobiol MP3, Tecknoss Den-
machined collar of 0.5 mm; tulip-shaped platform- tal) was applied into the surgical site to fill the socket
switching emergence profile of 0.3 mm; hexagonal in- and to reduce any gaps between the implant and the
ternal connection; and 3.8-, 4.25-, or 5.0-mm-diameter residual bone.
(10.0-mm or 11.5-mm length) were used. The thickness of the mucosa was measured with
One single experienced surgeon performed all sur- a periodontal probe, and a 1-mm or 2- to 3-mm-high
geries (C.P.). cover-healing screw was positioned following a non-
A careful occlusal and periodontal examination submerged healing approach.
was performed on each patient, including presence
of plaque, gingivitis, pocket depth, and radiographic Early and Delayed Implant Placement
bone loss of all remaining teeth. Oral hygiene instruc- The surgical procedures were similar for the early and
tion and periodontal therapy were performed when delayed placements. No flaps were reflected.
and where indicated. An initial 1.2-mm-diameter drill was used to mark
Two days prior to the intervention, all patients the position, angle, and depth. The drill passed through
were asked to comply with a pharmacologic regime the mucosa (transmucosal), cortical bone, and cancel-
that included amoxicillin/clavulanic acid 1 g tablet lous bone under copious saline irrigation. A twist and
and application of chlorhexidine digluconate 0.20% calibrated drill at 225 rpm was used, and a site of the
gel (Corsodyl Gel, GlaxoSmithKline UK) twice a day, adequate depth and diameter was created while irri-
in accordance with a previous study.32Antibiotic gating with sterile saline solution.

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Prati et al

The entire rough surface was located in the bone, Gingival Thickness Evaluation
and the smooth surface neck was immersed in gingi- The soft tissue thickness around implants and their
val tissue (supracrestal placement). The thickness of corresponding mesial neighboring teeth was deter-
the mucosa was measured with a periodontal probe, mined at the 4-year follow-up. The soft tissue was
and a 1-mm or 2- to 3-mm-high cover-healing screw pierced midfacially at 3 mm apical to the gingival
was positioned following a nonsubmerged healing margin with an endodontic file (K-file Nr. 20, Dentsply-
approach (as mentioned earlier). No computer-aided Maillefer). The gingival biotype was defined as thick
surgical guides were used. (soft tissue thickness > 2 mm) or thin (soft tissue
thickness ≤ 2 mm).34–36
Postoperative Procedures
A surgical dressing (Coe-Pak, GC) was placed on the Radiographic Assessment
wound in all patients and removed at the first clinical Intraoral periapical radiographs of all implants were
control after 1 week. taken using a paralleling technique with Rinn-holders
Patients were instructed to follow a soft diet regime and analog films (Kodak Ektaspeed Plus, Eastman
for 1 week, to rinse 3 times/day with 0.12% chlorhexi- Kodak) after implant placement (baseline) and at 1, 3,
dine gel for 3 weeks, and to perform oral hygiene on the 6, 12, 24, 36, and 48 months after implant insertion.
Coe-Pak using a medium toothbrush for the first week The following parameters were used, and a proper
and for 2 weeks after surgical pack removal. Thereafter, standardization was performed before the start of
conventional brushing and flossing were permitted. the study. The target-film distance was approximately
30 cm with the sample, 0.41 seconds exposure at 70 kV
Prosthetic Rehabilitation and 8 mA. The radiographs were developed in a stan-
Prosthetic phases started after 3 months from implant dard developer unit at 25°C (Euronda), 12 seconds
insertion. No second surgeries to expose the implant developing and 25 seconds fixing according to the
neck were performed. Briefly, cover screws were re- manufacturer’s instructions. Patients were asked for a
moved, impression posts were placed, and impres- new radiograph when these characteristics were not
sions were made with polyether materials (Permadyne fulfilled.
and Garand, 3M ESPE) in customized trays for the pick- All radiographs were scanned with a slide scanner
up technique. with a resolution of 968 dpi and a magnification factor
Customized definitive abutments were screwed on of ×20.
the implants after approximately 15 days, and provi- Radiographic evaluation was performed in single-
sional resin crowns were cemented with temporary blind by one additional examiner (F.Z.). Before evaluat-
zinc-oxide eugenol cement (Temp Bond, Kerr). ing the radiographs, the examiner was calibrated using
Definitive prosthetic metal-ceramic rehabilitations, well-defined instructions and reference radiographs
made by two equally experienced prosthodontists, with different MBL measures. The crestal marginal
were positioned on definitive abutments and fixed bone and the bone-implant interface were examined
with polycarboxylate cement (Heraeus Kulzer) 12 to 15 to evaluate the marginal bone morphology. MBL was
days later.33 assessed at the mesial and distal implant surfaces by
The quantity of the extruded cement was reduced measuring the distance between the reference point
by filling the occlusal half of the crown and maintain- of the implant platform to the most coronal bone-to-
ing an occlusal space of the abutment screw channel implant contact level using a scale divided into 0.1-mm
to minimize the hydraulic pressure through slowing steps according to previous studies.37,38
cement escape. Patients were instructed to bite on a ImageJ software (National Institutes of Health)
cotton roll for 5 minutes. Subsequently, dental floss was used to perform all the measurements. Length
was used to remove the cement flow. and diameter of implants were used to calibrate the
measurement.39
Follow-up Implant Evaluation
Active periodontal therapy consisting of motivation, Evaluated Variables
instruction in oral hygiene practice, scaling, and root MBL was measured and evaluated according to the fol-
planing was performed during the entire time of ob- lowing variables:
servation; no bleeding on probing and pocket prob-
ing depth ≥ 3 mm were detected during the follow-up 1. Preoperative parameters: Implant location (maxilla/
procedures. Routine follow-up visits were performed mandible), implant position (anterior/posterior),
every 6 months from implant loading. Occurrence of sex (male/female), endodontically treated adjacent
endodontic treatments on implant-adjacent teeth was teeth (yes/no), smoke (yes/no), implant placement
also recorded. timing (immediate/early/delayed)

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Prati et al

2. Intraoperative parameters: Implant diameter by a recurrent unscrewing of the implant abutment.


(3.8/4.25/5.0 mm) The abutment was removed, and the area was careful-
3. Postoperative parameters: Gingival thickness (yes/no) ly treated with chlorhexidine 0.12%. After 1 month, a
new abutment was screwed, and a new metal-ceramic
Statistical Analysis crown was cemented.
Statistical analyses were performed using Stata 13.1 Two series of periapical radiographs are reported in
(StataCorp). Figs 1 and 2.
Linear regression models were fitted to evaluate the
existence of any significant difference regarding end- MBL Assessment
odontically treated adjacent teeth (yes/no), times (1, MBL of implants and all the clinical parameters evalu-
3, 6, 12, 24, 36, and 48 months), and the interactions ated with linear logistic regression analysis are report-
between endodontically treated adjacent teeth and ed in Table 1.
time. To take into account the correlation in the data Overall mean MBL showed progressive variation
due to the presence of multiple implants per subject, during the evaluation time (48 months). Bone MBL
the aforementioned regression models were estimated variation was observed at preload time (T1 and T3)
following a generalized estimating equation (GEE) ap- with significant changes at T6, T12, and T24 (0.47 ± 0.57,
proach. The estimates of coefficients’ standard errors 0.67 ± 0.78, and 0.89 ± 0.81 mm, respectively), as illus-
and confidence intervals were adjusted using a robust trated in Table 1.
variance-covariance estimator.40 The same analysis was No statistically significant differences (P > .05) with
performed for all the operative variables. minimal variation were observed at T24, T36, and T48
A multiple linear regression with stepwise selection (0.89 ± 0.81, 0.95 ± 0.85, and 0.99 ± 0.68 mm, respec-
was fitted to evaluate the relationship between MBL at tively). The reduction of standard deviation values at
36 and 48 months and the following variables: sex (male/ T48 suggests a more stable MBL.
female), smoke (yes/no), location (mandible/maxilla), Linear logistic analysis of preoperative parameters
implant position (anterior/posterior), endodontic ad- revealed no statistical differences for implant position,
jacent teeth (yes/no), adjacent teeth coronal restora- sex, and smoke. In contrast, implant location, presence
tion (direct/indirect/no restoration), implant placement of endodontic adjacent teeth, and implant placement
timing (immediate/early/delayed), implant diameter timing revealed significant differences (P < .05).
(3.8/4.25/5.0 mm), and gingival thickness (thin/thick). Concerning implant diameter as intraoperative and
Boxplots were created using Sigma plot 12 soft- gingival thickness as postoperative parameters, no
ware (Systat) to show the range and distribution of MBL significant differences were present (P > .05).
MBL (mm) as a function of implant placement timing Considering implant location, implants placed in
(immediate, early, delayed) at 1, 3, 6, 12, 24, 36, and 48 the maxilla showed reduced bone loss compared with
months from implant insertion. those placed in the mandible (P < .05).
Implants placed in sites with adjacent endodontically
treated teeth showed more bone loss at T36 (mean MBL
RESULTS was 0.70 ± 0.68 mm vs 1.16 ± 0.69 mm, respectively); the
differences were statistically significant (P < .001).
Study Population and Demographic Data Considering implant placement timing, all groups
According to the inclusion/exclusion criteria, 76 pa- (immediate, early, and delayed) displayed significant
tients (128 implants) were studied with a mean age of variation (Table 1). Early implants showed the lowest
55.6 ± 10.7 years (42 women and 34 men). Eight pa- bone loss at all the evaluation times. Immediate im-
tients (17 implants) were identified as smokers, con- plants demonstrated a similar behavior up to T6, while
suming from 10 to 20 cigarettes/day, and included delayed implants showed the highest bone loss and
in the study; these patients were distributed evenly significant differences with other groups.
across the three groups (three in immediate, two in Multilevel mixed logistic regression analysis at T36
early, and three in delayed group). and T48 is reported in Tables 2 to 5.
The survival rate was 98.4%, as two implants (de- The analysis confirms the significant influence of
layed group) failed during the observational time. endodontically treated adjacent teeth (P < .0001),
Two nonsmoker patients dropped out after 6 and implant placement timing (P = .044), and implant lo-
36 months, respectively. The total dropout rate was cation (maxilla/mandible) (P = .019) parameters. No
2.58%. No wound infection, osteitis, and bone graft se- statistical differences were observed for the other
questration occurred during the follow-up period. parameters (P > .05) (Table 2). Multiple linear regres-
The success rate was 97.65%. Mucositis was ob- sion after stepwise selection (Table 3) additionally
served in one patient after 3 months and was caused confirms that all three variables statistically affected

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Prati et al

Postextraction Early insertion 1 mo 3 mo

12 mo 24 mo 36 mo 48 mo

Fig 1   Female nonsmoker patient 49 years of age with early postextractive site (first mandibular right root treated molar was ex-
tracted for root fracture 2 months before). A 4.25 × 11.5-mm platform-switched implant was placed nonsubmerged using flapless
technique. No complications were observed. After 3 months, an impression was taken without stage-two surgeries. MBL was stable
at preloading time (1 and 3 months from implant insertion) and at 12 and 24 months (postloading time). Please note that the crown
margin ends approximately 2 mm from the alveolar bone. In this way, cement excesses may be more easily removed. Crestal bone
loss has been evidenced at 36 and 48 months, likely related to the presence of a wide space between the implant restoration and
the neighbor teeth.

Preoperative Extraction Early insertion 3 mo

12 mo 24 mo 36 mo 48 mo

Fig 2   Female patient 42 years of age with maxillary right premolar presenting a vertical root fracture and active periapical lesion
(periapical fistula). Extraction was performed, and implant insertion was scheduled 3 months after that (early insertion). A 4.25 × 10-
mm implant was inserted with a flapless technique. Impressions were taken after 3 months, and a provisional crown was cemented.
Initial bone loss was observed during preloading period. MBL remained stable up to 48 months. Note the presence of two endodontic
treated teeth 10 to 12 months from implant insertion. Bone loss was observed.

MBL at T36 (P value was .001 for endodontic treated time. Implant placement timing still appears to be a
adjacent teeth, .031 for implant location, and .044 for factor that significantly affects MBL only after stepwise
implant placement timing). logistic regression, confirming data shown in Table 1
Multilevel mixed logistic regression analysis at T48 is (P = .020) (Table 5).
reported in Table 4. Interestingly, none of the evaluat- Boxplot representations concerning implant
ed parameters appear to significantly affect MBL at this placement timing are shown in Fig 3. The delayed

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Table 1   Linear Regression Results for All Operative Parameters Using GEE with Robust Covariance
Estimator to Account for Correlation in Data
n T1 T3 T6 T12 T24 T36 T48
Preoperative parameters
Implant location
  Maxilla 70 0.15 ± 0.38Aa 0.23 ± 0.65Aa 0.32 ± 0.51ABa 0.50 ± 0.61Ba 0.72 ± 0.76Ca 0.75 ± 0.75Ca 0.86 ± 0.69Ca
  Mandible 58 0.29 ± 0.44Aa 0.36 ± 0.49Aa 0.63 ± 0.67Bb 0.90 ± 0.75Cb 1.05 ± 0.80Ca 1.20 ± 0.87Cb 1.19 ± 0.71Ca
Implant position
  Anterior 16 0.20 ± 0.39Aa 0.22 ± 0.60Aa 0.39 ± 0.57Ba 0.50 ± 0.69Ba 1.18 ± 0.77Ca 0.91 ± 0.89Ca 0.80 ± 0.64Ca
  Posterior 112 0.22 ± 0.40Aa 0.29 ± 0.57Aa 0.48 ± 0.52Ba 0.65 ± 0.70Ca 0.87 ± 0.76Da 0.95 ± 0.81Da 1.03 ± 0.68Da
Sex
  Male 57 0.12 ± 0.36Aa 0.15 ± 0.41 Aa 0.29 ± 0.54Ba 0.52 ± 0.68Ca 0.74 ± 0.66Da 0.83 ± 0.71Da 0.85 ± 0.64Da
  Female 71 0.27 ± 0.49Aa 0.39 ± 0.65Ab 0.59 ± 0.61Bb 0.82 ± 0.69Cb 1.05 ± 0.82Da 1.08 ± 0.91Da 1.21 ± 0.68Da
Endodontic adjacent teeth
  No 59 0.19 ± 0.38Aa 0.25 ± 0.56Aa 0.42 ± 0.61Ba 0.56 ± 0.69Ba 0.82 ± 0.73Ca 0.70 ± 0.68BCa 0.88 ± 0.68Ba
  Yes 69 0.23 ± 0.39Aa 0.28 ± 0.51 Aa 0.49 ± 0.56Ba 0.76 ± 0.68Ca 0.95 ± 0.65Da 1.16 ± 0.69Eb 1.17 ± 0.68Ea
Smoke 17 0.11 ± 0.42 Aa 0.12 ± 0.52 Aa 0.19 ± 0.56Aa 0.57 ± 0.75Ba 0.81 ± 0.86Ca 0.82 ± 0.96Ca 0.84 ± 0.67Ca
  Smokers 111 0.22 ± 0.41 Aa 0.27 ± 0.53Aa 0.46 ± 0.52Ba 0.69 ± 0.35Ba 0.88 ± 0.75Ca 0.97 ± 0.89Ca 1.07 ± 0.65Ca
  Nonsmokers
Implant placement timing
  Immediate 24 0.09 ± 0.30Aa 0.14 ± 0.35Aa 0.23 ± 0.27Ba 0.61 ± 0.59Ca 0.80 ± 0.62Ca 0.73 ± 1.07Ca 0.76 ± 0.58Ca
  Early 21 0.01 ± 0.18Aa 0.03 ± 0.29Aa 0.10 ± 0.47Aa 0.22 ± 0.66Bb 0.53 ± 0.67Ba 0.66 ± 0.71Bab 0.73 ± 0.57Ba
  Delayed 83 0.29 ± 0.45Ab 0.39 ± 0.62 Ab 0.62 ± 0.66Bb 0.82 ± 0.68Ca 1.02 ± 0.76Da 1.16 ± 0.81Db 1.22 ± 0.69Db
Intraoperative parameter
Implant diameter
  3.8 53 0.27 ± 0.30Aa 0.34 ± 0.33Aa 0.43 ± 0.27ABa 0.60 ± 0.69Ba 0.76 ± 0.70Ba 0.99 ± 0.70Ca 0.95 ± 0.67Ca
  4.25 56 0.22 ± 0.19Aa 0.33 ± 0.29Aa 0.56 ± 0.47Ba 0.76 ± 0.64Ba 1.07 ± 0.72Ca 0.96 ± 0.72Ca 1.08 ± 0.67Ca
  5.0 19 0.11 ± 0.41 Aa 0.08 ± 0.62 Aa 0.24 ± 0.64Ba 0.57 ± 0.84Ca 0.75 ± 1.01Da 0.83 ± 1.01Da 0.91 ± 0.65Da
Postoperative parameter
Gingival thickness
  Thin 73 0.19 ± 0.34Aa 0.27 ± 0.39Aa 0.53 ± 0.58Ba 0.75 ± 0.66Ba 0.97 ± 0.77BCa 1.06 ± 0.82Ca 1.16 ± 0.72Ca
  Thick 55 0.25 ± 0.48Aa 0.31 ± 0.75Aa 0.38 ± 0.64ABa 0.53 ± 0.75Ba 0.78 ± 0.79BCa 0.81 ± 0.81Ba 0.80 ± 0.65Ba
Total 128 0.21 ± 0.38A 0.28 ± 0.56A 0.47 ± 0.57B 0.67 ± 0.78C 0.89 ± 0.81D 0.95 ± 0.85D 0.99 ± 0.68D
The implant was used as the unit of analysis (MBL values expressed as mean ± SD). Different superscript letters represent statistically significant
values (P < .05) in the same horizontal row (uppercase letters) or in the same column (lowercase letters).

Table 2   Multilevel Mixed Logistic Regression Exploring Factors Associated with MBL at 36 Months
Groups Coefficient Robust SE 95% CI P value
Preoperative parameters
Sex 0.204 0.144 (–0.079; 0.487) .158
Location 0.373 0.159 (0.061; 0.685) .019
Smoke 0.252 0.146 (–0.034; 0.137) .084
Position –0.276 0.169 (–0.609; 0.056) .104
Endodontically treated adjacent teeth 0.501 0.143 (0.219; 0.780) < .0001
Implant placement timing 0.181 0.089 (0.005; 0.357) .044
Intraoperative parameters
Implant diameter 0.052 0.118 (–0.179; 0.283) .659
Postoperative parameters
Gingival thickness –0.128 0.135 (–0.394; 0.137) .343

Table 3   Multiple Linear Regression After Stepwise Selection for Factors Associated with MBL at
36 Months
Groups Coefficient Robust SE 95% CI P value
Implant placement timing 0.168 0.083 (0.003; 0.337) .045
Location 0.335 0.155 (0.031; 0.639) .031
Endodontically treated adjacent teeth –0.57 0.335 (–1.228; 0.859) .001

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Table 4   Multilevel Mixed Logistic Regression Exploring Factors Associated with MBL at 48 Months
Groups Coefficient Robust SE 95% CI P value
Preoperative parameters
Sex 0.226 0.190 (–0.146; 0.598) .234
Location 0.138 0.237 (–0.326; 0.604) .559
Smoke 0.252 0.146 (–0.034; 0.137) .084
Position –0.186 0.308 (–0.792; 0.419) .546
Endodontically treated adjacent teeth 0.329 0.172 (–0.009; 0.668) .056
Implant placement timing 0.180 0.150 (–0.113; 0.475) .229
Intraoperative parameters
Implant diameter 0.075 0.121 (–0.161; 0.31) .532
Postoperative parameters
Gingival thickness –0.224 0.186 (–0.254; 0.432) .227

Table 5   Multiple Linear Regression After Stepwise Selection for Factors Associated with MBL at
48 Months
Groups Coefficient Robust SE 95% CI P value
Implant placement timing 0.231 0.998 (0.362; 0.427) .020
Gingival thickness –0.291 0.280 (0.334; 1.432) .076

Immediate Early Delayed


3.0 3 4
2.5
2 3
2.0
MBL (mm)

MBL (mm)

MBL (mm)
1.5 1 2
1.0
0.5 0 1
0 –1 0
–0.5
–1.0 –2 –1
T1 T3 T6 T12 T24 T36 T48 T1 T3 T6 T12 T24 T36 T48 T1 T3 T6 T12 T24 T36 T48
Time (mo) Time (mo) Time (mo)

Fig 3   Boxplot representation of placed implants at different evaluation times. Outliers are represented by circle points.

group showed the highest presence of outliers, in


100
particular after T6 from insertion (postloading pe- 90
riod). The early group showed the most stable MBL 80
values (less wide distributions) up to T6 (preloading 70 60–70
60 50–59
time) and at T48. 50 40–49
%

The graph of final insertion torque values dis- 40 30–39


30 20–29
tributed into implant placement timing groups 20
is reported in Fig 4. A high percentage (43.9%) of 10
torque values > 50 N/cm2 was observed in the de- 0
Immediate Early Delayed
layed group, while the early and immediate groups
revealed a similar final insertion torque distribution, Fig 4   Final insertion torque graph values distributed according
to implant placement timing (immediate, early, and delayed). A
with few discrepancies. greater percentage of insertion torque values < 50 N/cm2 were
observed in the delayed group.

DISCUSSION nonsubmerged technique, confirming the results ob-


tained from a 2-year prospective study.33
The present study aimed to investigate which clinical Different preoperative variables have been ana-
factors after 4 years may affect MBL around platform- lyzed in this study. Some of them were revealed to
switched implants with an enlarged neck placed with a greatly affect MBL.

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Prati et al

Implant location, presence of endodontic adjacent Implant placement timing (immediate, early, and
teeth, and implant placement timing were significant- delayed) was not randomly decided, but made on the
ly related to MBL at T36; the latter remained significant basis of several clinical criteria: presence of acute endo­
at T48. dontic periapical lesion (with pain, fistula, exudate/
In multilevel linear logistic regression, the implant pus, tenderness, and radiographic apical translucency,
location parameter was statistically different, as the or all of them) and/or the presence of chronic periapi-
maxilla reported lower bone loss. This trend was con- cal disease (Periapical Index 3–4).59
stant from T6. Other studies reported similar results.41,42 Considering sex, female patients showed an in-
The presence of endodontically treated adjacent creased MBL after 3 years, compared with male
teeth is rarely reported in implant clinical investiga- patients (mean MBL was 1.08 mm vs 0.83 mm, respec-
tions.43–46 This parameter was included in the present tively). These differences were not statistically signifi-
analysis because it is a frequent clinical condition, par- cant and, subsequently, clinically irrelevant. From the
ticularly when single implant rehabilitations are con- literature, male patients seem to have higher risks of
sidered. Indeed, 69 out of 128 implants presented at implant failure; however, these data are controversial,
least one adjacent tooth with an endodontic treatment as it is difficult to correlate peri-implant bone loss and
(53.9%). The presence of endodontically treated teeth patient sex.60
adjacent to the implant was responsible for a marked, In the present study, smoking was found to not sig-
even significant only at T36, marginal bone loss. A num- nificantly affect MBL in the medium term. The small
ber of studies evidenced marginal bone loss in teeth sample size of smoking patients and the group dis-
root canal treatments.47–50 crepancies (17 implants in 8 patients vs 92 implants
Other investigations suggested and/or supported in 57 patients) may justify this finding. A limit of 20
the negative influence of treated root canal on adja- cigarettes/day has been adopted in the present study
cent implants.45,51 following the distinction of moderate smokers found
Localization of dormant bacteria around asymp- in a previous work, where significantly higher failure
tomatic endodontic treated teeth into the dentinal tu- rates were found in patients smoking more than 20
bules or along accessory canals is well recognized.52–56 cigarettes/day, whereas no differences were found be-
These bacteria may be able to maintain a persis- tween patients smoking 1 to 10 cigarettes/day (9.1%)
tent inflammatory state on adjacent sites, with the re- and 10 to 20 cigarettes/day (12%).29
sult of higher bone tissue being more susceptible to Implant position parameter did not significantly in-
inflammation.55,56 fluence MBL at T36 and at T48 (P > .05). The group dis-
For these reasons, a radiologic follow-up of endo­ crepancies may have influenced this result.
dontic treated teeth might be important to identify Gingival thickness was evaluated in all patients at
a critical condition that may affect bone architecture the 48-month follow-up. Interestingly, even though
remodeling. thin biotype showed higher values of MBL, this param-
Implant placement timing was found to be the most eter appears not to influence MBL at 36 and 48 months
significant factor affecting MBL in this study on non- (P > .05), and this variation was clinically undetectable.
submerged platform-switched tulip-shaped implants. The enlarged neck was partially immersed along
The delayed group (implant placement timing) re- the soft tissue thickness, the entire 0.50-mm smooth
vealed significant differences from T3 to T48, showing machined neck surface was close to the most super-
greater bone loss compared with both immediate ficial gingiva, and the rough surface was just at supra-
and early implants. Indeed, boxplots (Fig 3) clearly crestal placement level.
evidence that delayed implants presented a wider dis- Several benefits may be provided following the
tribution of implants with MBL values > 1.0 mm at nonsubmerged technique. As cover screws (or healing
T48. These changes, although difficult to detect clini- screws, depending on the soft tissue thickness) were
cally, may provide important information to detect in- exposed at soft tissue levels, additional surgeries be-
creased bone remodeling. fore the prosthetic phases are avoided. The implant-
The presence of thicker cortical mature bone in the abutment connection, as well as the crown margins,
delayed group may be responsible for higher torque were more distant from bone tissues, allowing a bet-
values (Fig 4) and higher stress on marginal tissue dur- ter control of cement flowing from the restoration and
ing drilling and insertion procedures. Drilling proce- avoiding the risks for cement overflow and retention in
dures at the implant site may be responsible for bone proximity with the bone tissues.61
necrosis and bone smear layer formation, inducing the This risk was reported in several studies where sub-
activation of osteoclasts and vascularization damage. crestal (submerged) or equicrestal implants were per-
Both of these conditions may be responsible for higher formed, considering that subgingival cement excess
bone resorption of the mature cortical bone.57,58 cannot be adequately controlled62–64 or considering

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Prati et al

the use of irritating methacrylate-based cements.65 A helped to standardize the processes of x-ray acquisi-
recent study evaluated clinical radiographic and im- tion, development, and analysis.
munologic parameters around platform-switched It must be taken into account that the reduced bone
implants with cement-retained or screw-retained loss values reported may be influenced by the exper-
restorations.66 The conclusions were that the type of tise of the operator who performed the surgeries and
crown retention does not affect bleeding on probing, the possibility of patients being included in a hygienic
pocket depth, MBL, and levels of IL-1B. In contrast, in recall program. Moreover, the insertion protocol was
the present study, a nonirritating polycarboxylate ce- not standard, but out-of-label. In this way, this implant
ment was used as the luting agent. may behave as a Straumann Tissue level with a shorter
MBL values follow a similar trend compared with smooth neck.
those previously reported with other implant brands,67 This protocol will be further validated with long-
neck,68 insertion depth,5 and surgical interventions.21 term follow-up.
A previous randomized clinical trial evaluating bone-
level implants placed submerged or with a transmuco-
sal approach found similar MBL values at 36 months.5 CONCLUSIONS
Likewise, MBL remained stable after the first 12 months
from insertion, where the greater bone-level changes Conclusions may be summarized as follows: (1) tulip-
occurred.5,8 shaped neck platform-switched implants may be
The study demonstrated that significant bone-level placed at tissue level (nonsubmerged) with a minimal-
changes/remodeling during the preload period occur. ly invasive flapless technique; (2) the present protocol
This concept has also been reported with other im- demonstrated reduced bone loss in the early phases
plants and surgical approaches.20,21 from implant placement and MBL stability at 36 and 48
Indeed, in the present study, mean MBL at 3 months months; (3) among all the evaluated parameters, only
(preload) was statistically different compared with MBL implant placement timing appears to significantly af-
at 6 months (postload) (P = .001), with the values being fect MBL before loading and during the entire period
0.28 ± 0.56 and 0.47 ± 0.57, respectively, thus corrobo- of observation; and (4) delayed implant placement was
rating this hypothesis. responsible for higher bone loss compared with early
Data on implant depth insertion are mostly from his- and immediate implants.
tologic studies.48 Implants with a tulip-shaped (flared)
neck placed in a most-apical position revealed more
bone loss compared with the same implants placed su- ACKNOWLEDGMENTS
pracrestally. This was attributed to the removal of a great
portion of the coronal bone, thus potentially compro- The authors claim to have no financial interest, either directly
or indirectly, in the products or information listed in the article.
mising blood supply of the remaining cortical bone.13,14
In accordance with these histologic findings, a
recent randomized clinical trial concluded that the
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