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

NCT07150910 | Completed

• 1 other identifier: 2021/15
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Hygiene

Outcome Measures

Primary Outcomes (2)

• Plaque Levels

  Plaque levels were assessed using the Turesky modification of the Quigley and Hein Plaque Index (T-QHPI). In each participant, dental plaque was disclosed using Mira-2-Ton® (Duisburg, Germany) and then rinsed with water (10 mL for 10 seconds). The stained plaque was scored on a scale from 0 to 5 as follows: 0 = no plaque; 1 = separate flecks of plaque at the cervical margin; 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin; 3 = plaque covering not more than one-third of the tooth surface; 4 = plaque covering more than one-third but not more than two-thirds of the tooth surface; 5 = plaque covering more than two-thirds of the tooth surface.

  2 weeks

• Gingival condition

  Gingival condition was evaluated using the Papillary Bleeding Index (PBI) introduced by Saxer and Mühlemann. Measurements were performed by a blinded, calibrated examiner on four sites per tooth (mesiobuccal, distobuccal, mesiolingual, and distolingual). A manual UNC-15 mm periodontal probe (Hu-Friedy, Chicago, IL, USA) was carefully inserted into the gingival sulcus at the base of the papilla on the mesial side and moved coronally toward the tip of the papilla. The same procedure was repeated on the distal aspect. Bleeding severity was scored on a scale from 0 to 4: 0 = no bleeding; 1 = a single discreet bleeding point visible after 20 seconds; 2 = a fine line of blood or multiple bleeding points in the papilla; 3 = blood filling the entire interdental space; 4 = profuse bleeding that overflows from the interdental area

  2 weeks

Study Arms (2)

IDB

ACTIVE COMPARATOR

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

Behavioral: Interdental brush

RBIC

ACTIVE COMPARATOR

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

Behavioral: Rubber bristles interdental cleaner

Interventions

Interdental brush BEHAVIORAL

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.

IDB

Rubber bristles interdental cleaner BEHAVIORAL

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.

RBIC

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bülent Ecevit University

Zonguldak, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 2, 2025
• Study Start: September 6, 2021
• Primary Completion: August 26, 2022
• Study Completion: August 26, 2022
• Last Updated: September 8, 2025

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)