The Effect of Different Shapes of Interdental Brushes in the Management of Peri-implant Mucositis and Gingivitis

NCT03575858 | Withdrawn

• 1 other identifier: 2017/01230
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Implants, Single-Tooth

Keywords

Single dental implants; Barrel Shaped Interdental toothbrush; Tapered Interdental toothbrush; peri-implant mucositis and gingivitis

Outcome Measures

Primary Outcomes (1)

• The changes in peri-implant tissue health as assessed by bleeding on probing (BOP).

  The changes in BOP at 6 sites per implant at 3 time points - from baseline to 2-weeks and to 4-weeks.

  Baseline, 2-week and 4-week

Study Arms (2)

Barrel shaped interdental brushes

EXPERIMENTAL

test group

Device: Barrel shaped interdental brush

Tapered interdental brushes

ACTIVE COMPARATOR

control group

Device: Tapered interdental brush

Interventions

Barrel shaped interdental brush DEVICE

Barrel shaped interdental brush Size SS 0.8mm

Barrel shaped interdental brushes

Tapered interdental brush DEVICE

Tapered interdental brush Size SS 0.6mm

Tapered interdental brushes

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Health System, Singapore: lead

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jia Hui Fu, Master

  National University Health System, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned into the barrel shaped (test) and tapered (control) interdental brushes groups

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: July 3, 2018
• Study Start: December 15, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share