CONSORT Randomized Clinical Trial
Comparison of Mineral Trioxide Aggregate and
iRoot BP Plus Root Repair Material as Root-end
Filling Materials in Endodontic Microsurgery:
A Prospective Randomized Controlled Study
Wei Zhou, DDS, Qinghua Zheng, DDS, PhD, Xuelian Tan, DDS, Dongzhe Song, DDS,
Lan Zhang, DDS, PhD, and Dingming Huang, DDS, PhD
Abstract
Introduction: This prospective randomized controlled
study evaluated the clinical and radiographic outcome
of endodontic microsurgery when using iRoot BP Plus
Root Repair Material (BP-RRM; Innovative BioCeramix
Inc, Vancouver, BC, Canada) or mineral trioxide aggre-
gate (MTA) as the retrograde filling material and
analyzed the relationship between some potential prog-
S urgical intervention is
nostic factors and the outcome of the surgery.
Methods: By using strict inclusion and exclusion
criteria, 240 teeth were successfully enrolled and
randomly and equally allocated to either the MTA or
BP-RRM treatment group. A standardized surgical pro-
cedure was performed by a single operator. The patients
were followed up at 1 week, 3 months, 6 months, and
12 months; follow-up included clinical and radiographic
examination. Clinical and radiographic evaluations
acquired at the 12-month follow-up were taken as the
primary outcome. For the identification of prognostic
factors, the dichotomous outcome (success vs failure)
was taken as the dependent variable. Results: A total
of 158 teeth were analyzed at the 12-month follow-
up, including 87 teeth in the MTA group and 71 teeth
in the BP-RRM group. The success rate in the MTA
and BP-RRM groups was 93.1% (81/87 teeth) and
94.4% (67/71 teeth), respectively (P > .05). Three sig-
nificant outcome predictors were identified: quality of
root filling (P < .05), tooth type (P < .05), and size of
the lesion (P < .05) Conclusions: These results sug-
gest that BP-RRM is comparable with MTA in clinical
outcome when used as root-end filling materials in
endodontic microsurgery. (J Endod 2017;43:1–6)
From the Department of Conservative Dentistry, West China School of Stomatology, Sichuan University, Chengdu, Sichuan Province, China.
Qinghua Zheng and Dingming Huang contributed equally to this study.
Address requests for reprints to Dr Dingming Huang or Dr Qinghua Zheng, Department of Conservative Dentistry, West China School of Stomatology, Sichuan University,
14# 3rd Section, Renmin South Road, Chengdu, Sichuan Province 610041, China. E-mail address: dingminghuang@163.com (D. H.) or 191477722@qq.com (Q. Z.)
0099-2399/$ - see front matter
Copyright ª 2016 American Association of Endodontists.
http://dx.doi.org/10.1016/j.joen.2016.10.010
JOE — Volume 43, Number 1, January 2017
Key Words
endodontic microsurgery, iRoot BP Plus Root Repair Material, mineral trioxide aggre-
gate, randomized clinical trial, root-end filling material, success rate
required to preserve
teeth with post-treatment
Significance
Endodontic microsurgery is effective to preserve
teeth with post-treatment apical periodontitis.
apical periodontitis when
Our study evaluated the clinical outcome of end-
nonsurgical treatment fails
odontic microsurgery when mineral trioxide aggre-
to improve the condition
gate and iRoot BP Plus Root Repair Material were
(1). During the last
used as retrograde filling material in human sub-
20 years, apical surgery
jects.
has undergone marked
changes and evolved into
endodontic microsurgery (EMS), which involves the use of state-of-the-art equipment,
instruments, and more biocompatible materials (2).
For root-end filling, the ideal material should be biocompatible with host tissues,
nonresorbable, antibacterial, and dimensionally stable. It should seal off the commu-
nication between the root canal system and the surrounding tissues. Furthermore,
regeneration of the periodontal ligament should also be addressed (3). Because
none of the materials available before 1993 possessed these ideal characteristics, in
that year, mineral trioxide aggregate (MTA) (ProRoot MTA; Dentsply, Tulsa, OK) was
developed and introduced. Endodontic microsurgery using ultrasonic preparation
and MTA restorations has been reported to have a good success rate (ie, 94%) (4).
However, MTA also has some drawbacks, including a long setting time, high material
cost, low washout resistance, and difficulty in handling (5).
iRoot BP Plus Root Repair Material (BP-RRM; Innovative BioCeramix Inc, Vancou-
ver, BC, Canada), a type of bioceramic material, has recently been introduced into clin-
ical application to address these issues. It has been indicated for use in root-end filling
as well as root reparation. BP-RRM is a ready-to-use premixed bioceramic paste with a
calcium silicate composition (ie, calcium silicates, zirconium oxide, tantalum pent-
oxide, calcium phosphate monobasic, and filler agents). It requires the presence of wa-
ter to set and harden, and it requires a minimum of 2 hours to set according to the
manufacturer. It does not shrink during setting and has excellent physical properties.
MTA and iRoot BP Plus Root Repair Material 1
CONSORT Randomized Clinical Trial
Numerous studies have compared MTA and BP-RRM in vitro and
found that they exhibited similar characteristics (6–11). Furthermore,
a previous animal study demonstrated these materials show no
significant differences in healing when used as root-end filling materials
(12). However, no study has compared the clinical outcome of their use
in vivo in humans.
Because the type of root-end filling material can be a factor impact-
ing the prognosis of EMS (13), the purpose of this prospective random-
ized controlled study was to evaluate the clinical and radiographic
outcome when using BP-RRM or MTA as the retrograde filling material
in EMS. Because previous studies have shown that patient-related fac-
tors (eg, age and sex) and tooth-related factors (eg, tooth position,
size of periapical radiolucency, presence or absence of crown, pres-
ence or absence of alveolar dehiscence, and quality of root canal filling)
might affect the outcome of the surgery (14–17). We also analyzed the
relationship between these potential prognostic factors and the
outcome of EMS.
Materials and Methods
Subject Enrollment and Inclusion/Exclusion Criteria
The study was approved by the Ethics Committee of West China
School of Stomatology for Research on Human Subjects, Chengdu,
Sichuan Province, China, and informed consent was obtained from
all patients. All study participants were taken from the pool of patients
referred to the Department of Conservative Dentistry, West China Hos-
pital of Somatology, from December 2012 to February 2015.
Patients who had root canal treatment but presented with symp-
tomatic or asymptomatic apical periodontitis were included. In these
patients, teeth with class II mobility or greater, horizontal and vertical
fractures, or through-and-through lesions were excluded.
Sample Size Calculation
The clinical trial had been planned for December 2012 to
February 2015. According to our earlier records of endodontic surgery,
an average of at least 3 teeth underwent surgery each week. Thus, at least
342 teeth could be enrolled in our study. Considering that 20% of these
patients may decline participation or may be excluded because of the 3
reasons listed earlier, we decided to enroll 240 teeth in our study, with
an equal number of 120 teeth in each group.
Sample Size and Randomization Method
Written informed consent was obtained from all patients who
agreed to participate. Eight teeth were excluded because of the presence
of a vertical fracture, and 13 teeth were excluded because of the pres-
ence of a through-and-through lesion.
A total of 240 teeth were included in the randomized controlled
trial and were randomly allocated to either the MTA or the BP-RRM
group. The randomization process involved a selection of 1 from among
240 sealed envelopes by the operator immediately before the surgery;
this revealed to the operator which material to use.
Surgical Procedure
All clinical procedures were performed by a single operator with a
surgical operating microscope (Opmi PROergo; Carl Zeiss, Gottingen,
Germany) at the Department of Conservative Dentistry, West China
School of Somatology.
Briefly, patients were anesthetized using 2% lidocaine with
1:100,000 epinephrine (Septodont, Brampton, ON, Canada). A full-
thickness flap was reflected followed by osteotomy. After removing
2 Zhou et al.
the granular tissues, the root end was resected by 3 mm, without a bevel,
with a high-speed diamond bur (MANI, Tochigi, Japan) under copious
irrigation with sterile saline water. The root end was stained with meth-
ylene blue (Sigma-Aldrich, St Louis, MO) and inspected with micromir-
rors under 8 to 10 magnification to examine the root-end resection
and detect other overlooked anatomic details. The root-end cavity was
prepared along the long axis of the root with ultrasonic tips (Acteon,
Merignac, France). The root-end filling material used was ProRoot
MTA or BP-RRM, which was selected based on the randomization
method.
In the MTA group, after mixing according to the manufacturer’s
directions (in a 3:1 powder-to-water ratio using sterile water), white
ProRoot MTA was incrementally placed into the root-end preparations.
In the BP-RRM group, the putty was rolled into small 2- to 3-mm cones
and delivered into the root-end cavity in increments. Before the flap was
repositioned, a resorbable collagen membrane was placed in cases with
a buccal bony dehiscence. If the membrane was unstable, additional
bovine bone material was placed. The surgical area was closed with
5-0 sutures, and a postoperative radiograph was taken. The patients
were given postoperative instructions and prescriptions.
Clinical and Radiographic Evaluation
The patients were followed up at 1 week, 3 months, 6 months, and
12 months. A routine clinical and radiographic examination was per-
formed at each follow-up. Clinical signs and symptoms were recorded
at each assessment; these included loss of function, pain or swelling,
tenderness to percussion or palpation, mobility, sinus tract formation,
periodontal pocket formation, postoperative complications, and type of
restoration. The clinical signs and symptoms and radiographs acquired
at the 12-month follow-up were taken as the primary outcomes of this
study.
The radiographs were evaluated by 2 independent endodontic fac-
ulty members at the Department of Conservative Dentistry, West China
School of Somatology, using the criteria established by Rud et al (18)
and Molven et al (19) and modified by Shinbori et al (20). Neither
of the 2 observers knew into which group the radiographs fell. In cases
of disagreement about a radiograph, consensus was reached by discus-
sion. The healing classifications were as follows:
1. Complete healing: re-establishment of the lamina dura
2. Incomplete healing: some reduction of the former radiolucency
3. Unsatisfactory healing: no reduction or enlargement of the former
radiolucency
Assessment of Outcome
The outcome of the surgery using ProRoot MTA or BP-RRM as the
root-end filling material was defined as favorable healing or failure.
Favorable healing cases included those with an absence of clinical
symptoms or signs and with a radiographic classification of complete
healing or incomplete healing. Those cases with a radiographic classi-
fication of unsatisfactory healing or presenting with any clinical symp-
toms or signs were considered failures.
Potential prognostic factors for surgery were also examined,
including patient-related factors (ie, patient’s sex and age) and tooth-
related factors (ie, tooth position, size of periapical radiolucency, pres-
ence or absence of crown, presence or absence of alveolar dehiscence,
and quality of root canal filling).
The definition of quality of root canal filling contains 2 aspects: the
length and the density of the root canal filling (21). A root filling of
adequate quality had both adequate length and density; otherwise, the
root filling was considered inadequate.
JOE — Volume 43, Number 1, January 2017

Statistical Analysis
The Fisher exact test was used to compare the success rate of EMS
using ProRoot MTA or BP-RRM as the root-end filling material. To
analyze potential prognostic factors, the dependent variable was the
dichotomous outcome (ie, favorable healing vs failure). Chi-square
tests or the Fisher exact test were used to identify significant associations
between the outcome and variable factors. All statistical tests were per-
formed with 2-tailed statistical testing with the significance level set at
P < .05 using SPSS v23.0 software (IBM Corp, Somers, NY).
Results
Among the 240 teeth included in this study, a total of 82 teeth were
lost to follow-up; 158 teeth were examined at the 12-month follow-up.
Eighty-seven teeth from the MTA group and 71 teeth were examined
from the BP-RRM group. Details of the process of randomization in
this controlled study are provided in Figure 1.
The success rate of EMS using ProRoot MTA or BP-RRM as
the root-end filling material was 93.1% (81/87 teeth) and 94.4%
(67/71 teeth), respectively. Figure 2 shows examples of complete
(Fig. 2A–C), incomplete (Fig. 2D–F), and unsatisfactory healing
cases (Fig. 2G–I). There was no significant difference in the suc-
cess rate between the 2 groups (P > .05). Table 1 lists the cate-
gories of the outcome of healing by combined radiographic and
clinical assessment. Table 2 presents the distribution of cases ac-
cording to variable/category and bivariate analysis. The quality of
Asessed for eligibility (n = 272)
Declined to participate (n = 11)
Randomized (n = 240)
MTA
Allocated to intervention (n = 120)
Received intervention (n = 120)
Lost to follow-up (n = 33)
Fail to attend (n = 29);
Extraction due to
fracture (n = 1);
Lose touch (n = 3)
Analyzed (n = 87)
None excluded
Figure 1. A flow diagram of the process of the randomized controlled trial.
JOE — Volume 43, Number 1, January 2017
CONSORT Randomized Clinical Trial
root canal filling, tooth position, and size of the lesion had a sig-
nificant influence on the outcome (P < .05), whereas other factors
(eg, patient’s sex, age, presence or absence of crown, and pres-
ence or absence of alveolar dehiscence) did not (P > .05).
Discussion
In this study, the overall success rate of EMS in the MTA group
was 93.1%. The outcome of EMS using MTA as the root-end filling
material during modern surgical approaches has been thoroughly
investigated, and the healing rate is reported to be 80%–94%,
with a follow-up range of 1 to 6 years (4, 13, 14, 16, 22, 23).
In contrast, only 1 study has reported the clinical outcome of BP-
RRM, with an overall success rate of 92% (20), which was similar
to our finding. On the whole, it appears that EMS using these 2
bioceramic-based materials for the root-end filling has yielded prom-
ising results. This may be because of the development of modern
microsurgical techniques, which incorporate root-end cavity prepa-
ration with ultrasonic tips, the use of an endodontic microscope,
and more biocompatible root-end filling materials. With these tech-
niques, the probability of success has increased significantly and is
reported to be 1.58 times that of traditional apical surgery (4).
In the present study, we evaluated the outcome at 1 year after sur-
gery. Some studies have reported a chance of 5%–25% of regression to
apical periodontitis by 3 years or more after apical surgery (24–28).
Thus, the outcome from this time point may not be representative of
Exclusion (n = 21)
Through-and-through lesion (n = 13)
Vertical root fracture (n = 8)
BP-RRM
Allocated to intervention (n = 120)
Received intervention (n = 120)
Lost to follow-up (n = 49)
Fail to attend (n = 46);
Attend, but not
radiograph taken due to
pregnancy (n = 3)
Analyzed (n = 71)
None excluded
MTA and iRoot BP Plus Root Repair Material 3
CONSORT Randomized Clinical Trial

Figure 2. Representative periapical radiographs of cases in each category of outcome. (A–C) An example of complete healing. (A) The preoperative radiograph of
tooth #8. (B) The postoperative radiograph of tooth #8. (C) The 12-month follow-up radiograph of tooth #8 exhibits the re-establishment of the lamina dura. (D–
F) An example of incomplete healing. (D) The preoperative radiograph of tooth #13. (E) The postoperative radiograph of tooth #13. (F) The 12-month follow-up
radiograph of tooth #13 shows a reduction of the former radiolucency. (G–I) An example of an unsatisfactory healing. (G) The preoperative radiograph of tooth
#24. (H) The postoperative radiograph of tooth #24. (I) The 12-month follow-up radiograph of tooth #24 shows persistent periapical radiolucency.

the long-term effect of EMS. However, the 5-year prognosis can be pre-
dicted from the 1-year assessment with an accuracy of 91% and 95%
(24, 25). Moreover, a recent study by Song et al (29) found that there
was no significant difference in the clinical outcome after EMS between
the follow-up at 1 year and that at 4 years or more. Therefore, the 1-year
follow-up may have been sufficient to predict the long-term outcome of
apical surgery in our study.
BP-RRM, a newly introduced root-end filling material, has been
thoroughly compared in vitro with MTA in many respects such as
biocompatibility, sealing ability, and antimicrobial efficacy (6–11).
The results have indicated that BP-RRM as well as MTA are biocompat-
ible and do not have critical cytotoxic effects (6, 8, 10). In terms of
sealing ability, 2 in vitro bacteria leakage studies have shown that
MTA and BP-RRM putty yield a similar performance (7, 11).

4 Zhou et al. JOE — Volume 43, Number 1, January 2017

 CONSORT Randomized Clinical Trial
TABLE 1. Outcome of Healing Based on the Combined Radiographic and Lui et al (33) studied the influence of intraoperative dehiscence
Clinical Assessment in the Mineral Trioxide Aggregate (MTA) Group and the on the outcome of EMS and found that the presence or absence of
iRoot BP Plus Root Repair Material (BP-RRM) Group dehiscence may not be a prognostic factor. However, in another
MTA BP-RRM Total study, Song et al (15) suggested that the height of the buccal bone
(n = 87) (n = 71) (n = 158) plate was the only factor among periapical defects that significantly
affected the healing outcome. When teeth have a complete loss of
Category of healing n % n % n %
the buccal bone plate, the healing outcome may be compromised.
Complete healing 62 71.3 53 74.6 115 72.8 Although such cases were included in our study, we found that the
Incomplete healing 19 21.8 14 19.7 33 20.9
Unsatisfactory healing 6 6.9 4 5.6 10 6.3
presence of dehiscence was not predictive of failure. This may be
because guided regeneration techniques are used when a buccal
bony dehiscence is present because these techniques are beneficial
where periapical lesions communicate with the alveolar crest before
Moreover, compared with MTA, BP-RRM also exhibits similar antimi-
or during endodontic surgery (34–36).
crobial efficacy against Enterococcus faecalis and Candida albicans
According to Rahbaran et al (17), the presence of an adequate
(9). However, it is risky to extend these in vitro experimental results
coronal restoration positively affected the outcome of periapical sur-
to clinical situations and to assume the effect directly, given the
gery. Because it was difficult to confirm good coronal sealing in the
complexity of the in vivo environment. On account of the lack of
included teeth, we investigated the potential relationship between the
in vivo studies, we performed a clinical study comparing the effect of
presence and absence of a crown and success rates and found that
the 2 different root-end filling materials; notably, the results from our
they were not statistically correlated. The reason may be that the pres-
study are in agreement with the aforementioned in vitro experiments.
ence of a crown was not a single predictor of good coronal sealing, and
Our in vivo analysis may provide more direct clinical evidence of the
more detailed criteria are required for good coronal sealing.
use of BP-RRM as a root-end filling material in EMS.
The quality of the root filling was shown to be a major prognostic
Patient-related factors (eg, sex and age) did not seem to influence
factor in our study. This finding was in agreement with a previous meta-
the outcome of the surgery according to our study and many previous
analysis (14). However, it did not influence the outcome significantly in
studies (17, 20, 30–32). However, sex was found to be a significant
2 previous investigations (22, 37). Further research is necessary to
factor influencing the outcome of surgery in 2 other studies (16,
determine whether nonsurgical retreatment should be performed in
33). This difference may be attributed to differences in the sample
teeth with a poorly condensed root canal filling because this could be
population or to the fact that females are more concerned about
an economic burden for many patients.
their dental health and are more willing to return for follow-up.
Some studies have found that tooth type had no significant impact
In terms of tooth-related factors, there were significant differences
on the outcome (20, 30). However, in the present study, tooth type was
in outcome based on the size of the periapical radiolucency. This was in
a prognostic factor, and molars had the lowest rate of success (80.8%)
contrast to the findings of many previous studies (13, 14, 20, 30, 32,
among all types of teeth. Song et al (16) arrived at the same conclusion
33). However, in a meta-analysis by von Arx et al (14), cases without
as that of our study and attributed this difference to the difficulty of ac-
periapical lesions or with a lesion size #5 mm were associated with
cess to and the complexity of the root anatomy. Additionally, we hypoth-
a higher healing rate than that of cases with a lesion size >5 mm. These
esized that the differences among studies may result from case selection
authors speculated that cases of larger lesions require more time to heal
criteria, experimental design, and operator skills.
and have a greater chance of developing scar tissue during healing (14).
An animal model study comparing MTA and BP-RRM has reported
that, when evaluating the outcome of root-end surgery using periapical
radiography, no significant difference was found between the 2 treat-
TABLE 2. Distribution of the Group of Analyzed Cases per Variables/Category
and Bivariate Analysis ment groups. However, superior healing was detected on cone-beam
computed tomographic imaging and micro–computed tomographic
Teeth Success imaging in the BP-RRM group (12). In our study, even though we deter-
Factors n % n % P value mined the evaluation criteria based on the correlation between periap-
Sex .528 ical X-ray findings and clinical signs and symptoms, it can still be
Male 64 40.5 59 92.2 inferred that some minute difference that exists between the 2 materials
Female 94 59.5 89 94.7 may not be observed. Because the effectiveness of periapical radio-
Age 1.000 graphs in evaluating healing of the apical bone is limited, cone-beam
#45 136 86.1 127 93.4 computed tomographic imaging may serve as a better approach for
>45 22 13.9 21 95.5
Tooth type .009 evaluating the outcome of EMS. Nevertheless, its use in postoperative
Anterior 113 71.5 109 96.5 evaluation needs to be further justified.
Premolar 19 12.0 18 94.7 The present study was a randomized controlled trial, which
Molar 26 16.5 21 80.8 strengthened the confidence level of our findings. Because well-
Size of lesion .031
#5 mm 50 31.6 50 100.0 controlled randomized trials reduce potential uneven distribution of
>5 mm 108 68.4 98 90.7 prognostic factors between groups, their effect on outcome can be
Quality of root filling .007 limited to a reasonable degree. Moreover, we used a blinding proced-
Adequate 82 51.9 81 98.8 ure during the assessment of outcome, which prevented observers from
Inadequate 76 48.1 67 88.2
Alveolar dehiscence .293
preferring one treatment to the other.
Present 17 10.8 15 88.2 The recall rate in this study was approximately 66%, which may
Absent 141 89.2 133 94.3 have affected the results to a certain degree. However, some patients
Crown .527 who failed to attend the 1-year follow-up came back 2 years after the
Present 77 48.7 71 92.2 surgery. Therefore, we can renew our data with observation of a longer
Absent 81 51.3 77 95.1
postsurgery time in a future study.

JOE — Volume 43, Number 1, January 2017 MTA and iRoot BP Plus Root Repair Material 5
CONSORT Randomized Clinical Trial
In conclusion, in this prospective randomized controlled study,
there was no significant difference in the clinical outcomes of EMS
using MTA or using BP-RRM as the root-end filling material. This
result suggests that BP-RRM is a suitable root-end filling material.
More samples and more studies are needed to compare these 2 fore-
front materials.
Acknowledgments
The authors thank Dr. Hao Xu for his profound knowledge
regarding the experimental design and statistical analysis. We
are deeply grateful of his help in the completion of this study.
The authors deny any conflicts of interest related to this study.
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JOE — Volume 43, Number 1, January 2017