Dental Implants, Single-Tooth Clinical Trial
Official title:
Comparison of Barrel Shaped and Tapered Interdental Brushes in the Management of Peri-implant Mucositis and Gingivitis in Healthy Individuals: A Randomized Controlled Single Blinded Clinical Trial
Rehabilitation of edentulous spaces with dental implants has become a routine treatment
option as implants enjoy high survival rates over time. Accompanying this increase in implant
use, epidemiological studies have also reported escalating incidences of peri-implant
diseases. A recent meta-analysis reported that peri-implant mucositis and peri-implantitis
had high estimated weighted mean prevalences of 43% and 22% respectively. It is common
knowledge that gingivitis is the precursor of periodontitis. Similarly, peri-implant
mucositis too precedes peri-implantitis, which is a very challenging condition to treat.
Therefore, it is strongly recommended that peri-implant mucositis is managed effectively and
in a timely manner.
In order to reduce the inflammatory burden within the periodontium, mechanical plaque removal
is of utmost importance. Mechanical debridement alone, without any adjunctive aids e.g.
chlorhexidine, was found to be effective in preventing per-implant mucositis in short-term
clinical trials but did not always result in complete resolution of inflammation
(Heitz-Mayfield, et al. 2011, Schwarz, et al. 2015). Therefore, it can be speculated that
patient administered home care may play a role in eliminating soft tissue inflammation over
time.
The study aims to investigate and compare the efficacy of the barrel shaped and tapered
interdental brushes in reduction of soft tissue inflammation through removal of interproximal
plaque at both tooth and implant sites in patients with moderately rough surface tissue level
or bone level dental implants, which were restored with single screw or cement retained
crowns and in function for the past 2- 5 years.
The hypothesis of the study is that The barrel shaped interdental brush can remove more
supra- and sub-gingival plaque and thus have more reduction in soft tissue inflammation,
compared to the tapered interdental brush.
There are two study phases during the whole course of the study.
1) Examiner Calibration: 15 volunteers will be recruited for examiner calibration before the
study period. The intra-examiner reliability will be assessed using intraclass correlation
coefficient. The following clinical parameters will be collected at day 0 and day 7.
Clinical Parameters:
i. Probing pocket depths (PPD) (6 points per tooth) ii. Full mouth bleeding score (FMBS) iii.
Plaque at 8 sites (mesiobuccal, mesial, mesiolingual, lingual, distolingual, distal,
distobuccal, and buccal) per implant
2) Study phase: Stratified randomized single-blinded clinical controlled trial with 2
parallel arms is designed to achieve the aims of this research project. Study participants
who are visiting University Dental Cluster or any other dental clinics or hospitals will be
referred for this study. They will be enrolled at NUH University Dental Cluster if they
fulfill the study inclusion and exclusion criteria. They will be randomly assigned into the
barrel shaped (test) and tapered (control) interdental brushes groups and reviewed at 2 weeks
(± 3 days) and 4 weeks (± 3 days).
Randomization:
Study subjects will be randomly assigned to either test or control group based on a computer
generated randomization code after the screening of inclusion and exclusion criteria and
signing of the informed consent form.
Blinding and Allocation Concealment:
The study examiner who will be doing the clinical examination and collecting the study data
will be blinded to the group allocation; however, it is not possible to blind the study
subjects to the group allocation. The clinician, who will be performing the treatment and
providing oral hygiene instructions, will be given a sequentially numbered envelope
containing the subject's group allocation after non-surgical periodontal therapy has been
performed and before giving the oral hygiene instructions.
i. Probing pocket depths (PPD) (6 points per tooth) ii. Full mouth bleeding score (FMBS) iii.
Full mouth plaque score (FMPS) iv. Plaque at 8 sites (mesiobuccal, mesial, mesiolingual,
lingual, distolingual, distal, distobuccal, and buccal) per implant v. Characteristics of the
implant and implant crown: tissue level or bone level, supra- or submucosal margin, degree of
overcontour as seen on periapical radiograph vi. Peri-apical radiograph of implant taken with
parallel technique
Clinical parameters (i) to (iv) will be performed at baseline, 2-weeks and 4-weeks post
instrumentation.
Clinical parameter (v) and (vi) will be performed at baseline.
Radiographic Analysis:
Peri-apical radiographs will be only taken with paralleling technique to determine that there
is no peri-implant bone loss at baseline.
The sample size is calculated based on changes in mean bleeding on probing (BOP) (primary
outcome measure) between baseline and at 2 weeks post instrumentation review. Based on a
previous study (Larsen, et al. 2017), investigators calculated that 88 subjects (44 per
group) would be needed with 5% significance level and 80% statistical power. If investigators
expect an attrition rate of 20%, a total of 110 subjects (55 per group) will be needed.
Statistical Analysis:
Intention-to-treat analysis on the primary outcome variable (BOP) will be performed.
Last-observation-carried-forward method will be used in the event of subjects lost to
follow-up to the end of the study.
Descriptive statistics (mean and standard deviation for continuous variable; frequency and
percentage for categorical variable) will be reported to summarize the baseline
characteristics of study participants. Primary analysis will be patient-level analysis and
secondary analysis will be implant-level analysis. One implant, will be randomly selected by
computer generated random number, from each recruited subjects for patient-level analysis.
All implants from the recruited subjects will be included in the implant-level analysis.
At patient-level analysis, to examine the effect of shape of interdental brush,
difference-in-difference technique will be used for study the changes of outcomes (e.g. BOP,
PPD, FMBS and FMPS) from baseline at 2-weeks. Two-way ANOVA test with adjusting for implant
types will also be performed to study the effect of interdental brush shape in the form of
changes in BOP, PPD, FMBS and FMPS, at 2-week. Similar analysis will be replicated for
secondary study endpoint at 4-week. Generalized estimating equation (GEE) will be applied to
incorporate repeated measures data collected at 2- and 4-weeks. Baseline data and types of
implants will be adjusted in the model.
At implant-level analysis, to adjust for within-patient dependency, multilevel mixed effects
model will be built to assess the effect of interdental brush shape on the study outcome
variables (e.g. BOP, PPD, FMBS and FMPS) over time. A multilevel hierarchical three-level
structure was chosen with three levels of analysis being: timing of follow-up measurements
(level 1), implant (level 2), and patient (level 3). Baseline values of study outcome
variables and types of implants will be adjusted in the model.
Significance level for all analysis is set at p-value <0.05. All statistical analysis will be
carried out using STATA SE Version 15.0 (StataCorp. 2017. Stata Statistical Software: Release
15. College Station, TX: StataCorp LLC).
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