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

Bulent Ecevit University

Status: Completed

Conditions: Oral Hygiene

Treatments: Behavioral: Rubber bristles interdental cleaner; Behavioral: Interdental brush

Study type: Interventional

Funder types: Other

Identifiers

NCT07150910

2021/15

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• probing sulcus depth ≤ 3 mm and full-mouth bleeding on probing (BOP) score ≥ 20%
• presence of at least 20 natural teeth (excluding third molars), with a minimum of five teeth per quadrant
• at least four evaluable interproximal sites without crowns or restorations in each quadrant of the maxilla and mandible
• compatibility of both interdental cleaning devices with a minimum of four interproximal spaces per quadrant
• no prior experience with interdental cleaning tools
• willing to participate
• capable of understanding and complying with the study procedures and instructions.

Exclusion criteria

• smoking
• presence of severe gingivitis or clinical attachment loss
• systemic diseases
• use of antibiotics within the past three months
• use of anticoagulant medications or mouthwashes
• pregnancy or lactation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

IDB

Active Comparator group

Description:

The interdental brush(IDB) used in the study (TePe® Interdental Brushes Original) is available in nine different sizes, color-coded according to brush diameter, ranging from 0.4 mm to 1.5 mm

Treatment:

Behavioral: Interdental brush

RBIC

Active Comparator group

Description:

The rubber bristles interdental cleaner features soft, flexible, and tapered synthetic rubber bristles.

Treatment:

Behavioral: Rubber bristles interdental cleaner