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Search / Trial NCT03575858

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

Launched by NATIONAL UNIVERSITY HEALTH SYSTEM, SINGAPORE · Jun 29, 2018

Trial Information

Current as of May 24, 2025

Withdrawn

Keywords

Single Dental Implants Barrel Shaped Interdental Toothbrush Tapered Interdental Toothbrush Peri Implant Mucositis And Gingivitis

ClinConnect Summary

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: Strati...

Gender

ALL

Eligibility criteria

  • 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

About National University Health System, Singapore

The National University Health System (NUHS) in Singapore is a leading academic health system dedicated to advancing healthcare through innovative research, education, and patient care. Comprising a network of hospitals, specialty centers, and primary care clinics, NUHS integrates clinical practice with cutting-edge research and medical education, fostering collaboration among healthcare professionals, researchers, and educators. As a prominent clinical trial sponsor, NUHS is committed to conducting rigorous and ethical research to develop new treatments and improve patient outcomes, while also training the next generation of healthcare leaders in a dynamic and multidisciplinary environment.

Locations

Patients applied

0 patients applied

Trial Officials

Jia Hui Fu, Master

Principal Investigator

National University Health System, Singapore

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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