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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- The changes in peri-implant tissue health as assessed by bleeding on probing (BOP).
Study Overview
Brief Summary
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.
Detailed Description
There are two study phases during the whole course of the study.
- 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
- 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
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 open the envelope containing the subject's group allocation after non-surgical periodontal therapy but before giving the oral hygiene instructions.
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 21-80 years old
- •Medically healthy (ASA I or II)
- •Baseline plaque score of at least 75%
- •Probing depths of 4mm or less
- •Presence of interdental spaces that will allow an interdental brush (Size SS 0.8mm for barrel-shaped interdental brush and 0.6mm tapered interdental brush) to pass through without soft tissue trauma
- •Single moderately rough tissue level or bone level dental implants, which were restored with a single cement or screw-retained crown and in function for the past 2-5 years
- •Implants should have peri-implant mucositis defined as bleeding on probing without peri-implant bone loss after physiological remodelling (Rosen, et al. 2013)
- •Implants with at least 1mm of keratinized peri-implant mucosa
Exclusion Criteria
- •Embrasure space between the implant and adjacent tooth or between teeth is non-existent or too small to permit the use of an interdental brush
- •Self-declared pregnancy
- •Heavy smokers (1 pack a day)
- •Uncontrolled or poorly controlled medical conditions e.g. diabetes (HBA1c 8.5% and above)
- •Untreated oral conditions e.g. active periodontitis
- •On medications that will cause gingival enlargement
- •Any hyperplastic interdental papilla that will hinder interdental cleaning
- •Antibiotics intake within the past 3 months
- •Parkinson's disease and other debilitating diseases
Arms & Interventions
Barrel shaped interdental brushes
test group
Intervention: Barrel shaped interdental brush (Device)
Tapered interdental brushes
control group
Intervention: Tapered interdental brush (Device)
Outcomes
Primary Outcomes
The changes in peri-implant tissue health as assessed by bleeding on probing (BOP).
Time Frame: Baseline, 2-week and 4-week
The changes in BOP at 6 sites per implant at 3 time points - from baseline to 2-weeks and to 4-weeks.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jia Hui Fu
Assistant Professor
National University Health System, Singapore