NCT07150910

Clinical Efficacy and Patient Acceptance of Interdental Brushes and Rubber Bristles in Patients With Gingivitis

Comparison of the Clinical Efficacy and Patient Acceptance of Interdental Brushes and Rubber Bristles Interdental Cleaners in Patients With Gingivitis: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Bulent Ecevit University · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The primary aim of this clinical study is to compare the effects of IDBs and RBICs on the removal of microbial dental plaque and gingival bleeding in patients with gingivitis. Secondarily, the study aims to assess participants' satisfaction and attitudes toward using these tools.

Detailed description

This study involved 40 systemically healthy, right-handed, non-smoking patients aged 18-35 with gingivitis and no prior experience with interdental cleaning tools. Inclusion criteria required a probing depth ≤3mm, a full-mouth bleeding on probing score ≥20%, at least 20 natural teeth, and a minimum of four evaluable interproximal sites per quadrant compatible with both test devices. Key exclusion criteria were severe gingivitis, attachment loss, systemic diseases, recent antibiotic use, and pregnancy. Participants received standardized toothpaste, a toothbrush, and training in the modified Stillman brushing technique. Following a 2-week training phase on product use and a professional prophylaxis, they refrained from interdental cleaning for 3 days to allow plaque accumulation for baseline assessments (T-QHPI for plaque, PBI for gingival bleeding). The study employed a split-mouth design. After baseline, one side of the mouth was assigned an interdental brush (IDB - TePe® Original, sizes 0.4-1.5mm) for daily use, and the contralateral side was assigned a rubber bristle interdental cleaner (RBIC - TePe EasyPick™, XS/S or M/L size). Participants were instructed on proper insertion and technique for each device. After two weeks of use, clinical indices were re-recorded by a blinded examiner. Additionally, participants completed a questionnaire assessing their satisfaction with various aspects of the products (cleaning capacity, accessibility, ease of use, overall satisfaction, willingness to reuse, and pain experienced during use).

Conditions

• Oral Hygiene

Interventions

Type	Name	Description
BEHAVIORAL	Interdental brush	In accordance with the manufacturer's recommendations, the IDBs were stated to be suitable for multiple uses. Participants were advised to replace the IDB once the bristles lost their shape or if the metal wire became damaged.
BEHAVIORAL	Rubber bristles interdental cleaner	Two sizes were selected for the study: XS/S - Orange, designed for narrow and very narrow interdental spaces, and M/L - Turquoise, suitable for medium to large spaces. Since the tested RBICs were designed by the manufacturer for single use, participants were instructed to use a new RBIC at each application.

Timeline

• Start date: 2021-09-06
• Primary completion: 2022-08-26
• Completion: 2022-08-26
• First posted: 2025-09-02
• Last updated: 2025-09-08

Locations

1 site across 1 country: Turkey (Türkiye)