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

• ClinicalTrials.gov Identifier: NCT03872687
• Recruitment Status: Unknown
• First Posted: March 13, 2019
• Last Update Posted: March 13, 2019
• Sponsor: National University Health System, Singapore
• Information provided by (Responsible Party): Jia Hui Fu, National University Health System, Singapore

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Dental Implant	Device: single tufted brush with IDB; Device: interdental brushes	Not Applicable

Detailed Description:

There are two study phases during the whole course of the study. PHASE 1: EXAMINER CALIBRATION Examiner will be calibrated before the study period with 10 volunteers.

The intra-examiner reliability will be assessed using intraclass correlation coefficient. The volunteers will be recruited based on the inclusion and exclusion criteria.

Clinical Parameters:

i. Probing pocket depths (PPD) at 6 sites per implant ii. mBI at 6 sites per implant iii. mPI at 8 sites per implant Clinical parameters (i) to (iii) will be performed at day 0 and day 7.

PHASE 2: STUDY INTERVENTION 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 inclusion and exclusion criteria.

Groups:

• Test: 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.
• Control: Subjects in this group will only receive interdental brushes.

Randomization:

Study subjects will be randomly assigned into either test or control group based on a computer generated randomization code after screening of inclusion and exclusion criteria and signing of informed consent form.

Blinding and Allocation Concealment:

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 be given a sequentially numbered envelope containing the subject's group allocation after non-surgical periodontal therapy has been performed and before giving the oral hygiene instructions.

Clinical Parameters:

i. Probing pocket depths (PPD) (6 points per implant) ii. mBI (6 points per implant) iii. mPI (8 points per implant) iv. Characteristics of the implant and implant crown: tissue level or bone level, supraor submucosal margin, degree of overcontour as seen on periapical radiograph v. Peri-apical radiograph of implant taken with parallel technique Clinical parameters (i) to (iii) will be performed at baseline, 2-weeks, 1 month, 3 months, and 6 months post instrumentation.

Clinical parameter (iv) and (v) will be performed at baseline.

Radiographic Analysis:

Peri-apical radiographs will be taken with paralleling technique to determine that there is peri-implant bone loss beyond 2mm at baseline.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: An Evaluation of the Effectiveness of Single Tufted Brush in the Management of Peri-implant Mucositis in Healthy Individuals: A Randomised Controlled Single Blinded Clinical Trial
• Estimated Study Start Date: June 7, 2019
• Estimated Primary Completion Date: December 31, 2020
• Estimated Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: single tufted brush with IDB; 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; 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.
Active Comparator: interdental brushes; Subjects in this group will only receive interdental brushes 6 months.	Device: interdental brushes; Subjects in this group will only receive interdental brushes

Outcome Measures

Primary Outcome Measures :

1. the reduction in bleeding tendency [ Time Frame: baseline, 2-weeks, 1 month, 3 months, and 6 months post instrumentation ]
   The reduction in bleeding tendency as assessed by mBI at 6 sites per implant

Secondary Outcome Measures :

1. the reduction in plaque accumulation [ Time Frame: baseline, 2-weeks, 1 month, 3 months, and 6 months post instrumentation ]
   The reduction in plaque accumulation with a modified Plaque Index (mPI) at 8 sites (mesiobuccal, mesial, mesiolingual, lingual, distolingual, distal, distobuccal, and buccal) per implant

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Jia Hui Fu, Master; 65-6779 5555 ext 1649; denfjh@nus.edu.sg

Sponsors and Collaborators

National University Health System, Singapore

Investigators

• Principal Investigator: Jia Hui Fu, Master; National University Health System, Singapore

More Information

• Responsible Party: Jia Hui Fu, Assistant Professor, National University Health System, Singapore
• ClinicalTrials.gov Identifier: NCT03872687
• Other Study ID Numbers: 2018/01174
• First Posted: March 13, 2019
• Last Update Posted: March 13, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jia Hui Fu, National University Health System, Singapore:

dental implants, tufted brush, IDB, mucositis, gingivitis

Additional relevant MeSH terms:

Mucositis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases