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

NCT03575858 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-03-13

No results posted yet for this study

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

Interventions

DEVICE

Barrel shaped interdental brush

Barrel shaped interdental brush Size SS 0.8mm

DEVICE

Tapered interdental brush

Tapered interdental brush Size SS 0.6mm

Sponsors & Collaborators

  • National University Health System, Singapore

    lead OTHER

Principal Investigators

  • Jia Hui Fu, Master · National University Health System, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-15
Primary Completion
2019-12-31
Completion
2020-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03575858 on ClinicalTrials.gov