The Effectiveness of Single Tufted Brush in the Management of Peri-implant Mucositis

NCT03872687 | Unknown

• 1 other identifier: 2018/01174
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to investigate and compare the reduction in (1) soft tissue inflammation and (2) amount of plaque accumulation at implant sites with (test) or without (control) patient administered use of single tufted brush. Stratified randomized single blinded clinical controlled trial with 2 parallel arms is designed to achieve the aims of this research project. Study participants will be enrolled from NUH University Dental Cluster. They will be randomly assigned into the test (toothbrush, interdental brush, and single tufted brush) and control (toothbrush and interdental brush) groups and reviewed at 2 weeks (± 3 days), 4 weeks (± 3 days), 3 months (± 7 days), and 6 months (± 7 days).

Conditions

Dental Implant

Keywords

dental implants, tufted brush, IDB, mucositis, gingivitis

Outcome Measures

Primary Outcomes (1)

• the reduction in bleeding tendency

  The reduction in bleeding tendency as assessed by mBI at 6 sites per implant

  baseline, 2-weeks, 1 month, 3 months, and 6 months post instrumentation

Secondary Outcomes (1)

• the reduction in plaque accumulation

  baseline, 2-weeks, 1 month, 3 months, and 6 months post instrumentation

Study Arms (2)

single tufted brush with IDB

EXPERIMENTAL

Subjects in this group will receive a single tufted brush and interdental brushes of an appropriate size for 6 months.

Device: single tufted brush with IDB

interdental brushes

ACTIVE COMPARATOR

Subjects in this group will only receive interdental brushes 6 months.

Device: interdental brushes

Interventions

single tufted brush with IDB DEVICE

Subjects in this group will receive a single tufted brush and interdental brushes of an appropriate size that will fit the interdental spaces around the implant.

single tufted brush with IDB

interdental brushes DEVICE

Subjects in this group will only receive interdental brushes

interdental brushes

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• i. Age 21-70 years old ii. Medically healthy (ASA I or II) iii. Presence of interdental spaces that will allow an interdental brush to pass through without soft tissue trauma iv. Single moderately rough 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 v. Implants should have peri-implant mucositis that is defined as (Renvert, et al., 2018)
• Presence of clinical signs of inflammation, which are redness, shininess of the soft tissue surface, local swelling, with or without increase in probing depth
• Bleeding on probing
• No progressive peri-implant bone loss beyond 2mm from implant platform (Rosen, et al., 2013) vi. Implants with at least 1mm of keratinized peri-implant mucosa

You may not qualify if:

• i. Embrasure space between the implant and adjacent tooth is non-existent or too small to permit the use of an interdental brush ii. Self declared pregnancy iii. Heavy smokers (1 pack a day) iv. Uncontrolled or poorly controlled medical conditions e.g. diabetes (HBA1c 8.5% and above) v. Untreated oral conditions e.g. active periodontitis vi. On medications that will cause gingival enlargement vii. Any hyperplastic interdental papilla that will hinder interdental cleaning viii. Antibiotics intake within the past 3 months ix. Parkinson's disease and other debilitating diseases x. Subjects who are unable to give consent e.g. mentally challenged

Sponsors & Collaborators

• National University Health System, Singapore: lead

MeSH Terms

Conditions

Mucositis; Gingivitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases

Study Officials

• Jia Hui Fu, Master

  National University Health System, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Hui Fu, Master

CONTACT

65-6779 5555; denfjh@nus.edu.sg

Study Design

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

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: June 7, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share