Evaluation of a Novel Dual-Headed Toothbrush Design for Periodontal Health: Split-Mouth Randomized Blind Clinical Trial

NCT ID: NCT07030088

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2025-12-31

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness and patient satisfaction of a novel dual-headed toothbrush design compared to a conventional single-headed toothbrush in adult dental professionals aged 22-45 years with healthy gingival conditions. The main questions it aims to answer are:

Does the dual-headed toothbrush improve plaque removal efficiency compared to a single-headed toothbrush? Does the dual-headed toothbrush enhance brushing comfort, reduce brushing time, and improve user satisfaction? Researchers will compare the side of the mouth (cleaned with a dual-headed toothbrush) with the other side (cleaned with a single-headed toothbrush) in a randomized split-mouth design to see if the novel design leads to superior plaque control and better user experience.

Participants will:

Receive both toothbrush types (medium bristle) and identical toothpaste Be trained in the Bass brushing technique Use each toothbrush, twice daily, with the assigned toothbrush applied to its designated side of the mouth

Complete post-trial questionnaires on comfort, ease of use, and brushing time

Detailed Description

This clinical trial explores the comparative effectiveness and user experience of a novel dual-headed toothbrush design versus a conventional single-headed toothbrush using a randomized split-mouth methodology among adult dental professionals. Dental professionals were selected as participants due to their consistent oral hygiene habits and ability to comply with standardized brushing protocols.

The study investigates whether the dual-headed design can offer improved plaque removal efficiency, reduced brushing time, and greater comfort during use-factors that are increasingly relevant to both clinical performance and patient compliance in oral hygiene tools. Participants were trained to use both toothbrushes following the Bass technique and instructed to brush twice daily, with the left and right sides of the mouth assigned to different brushes.

The trial design allows for within-subject comparison, minimizing confounding variables such as brushing technique, motivation, and dietary habits. In addition to clinical measurements, participants' subjective experiences were captured through structured questionnaires focusing on comfort, ease of maneuverability, and time spent brushing.

This investigation aims to provide evidence to guide the development of more ergonomic and time-efficient toothbrush designs that improve plaque control without compromising user comfort. Findings from this study may influence the recommendation of dental hygiene tools, particularly for individuals seeking more efficient oral hygiene practices or patients with limited dexterity or who rely on caregivers.

Conditions

Dental Plaque Accumulation; Oral Hygiene Education Methods; Toothbrushing

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dual-Headed Toothbrush

Participants used a dual-headed manual toothbrush to clean one side of their mouth (maxillary and mandibular quadrants). Brushing was performed using the Bass technique, twice daily. This arm assesses the effectiveness, comfort, and time-efficiency of the novel dual-headed toothbrush design.

Group Type: EXPERIMENTAL

Dual-Headed Manual Toothbrush

Intervention Type: DEVICE

A novel toothbrush with a dual-headed design intended to clean both upper and lower buccal/ or upper and lower lingual/ palatal surfaces simultaneously. Participants were instructed to use this toothbrush on one side of the mouth only, twice daily using the Bass brushing technique. This intervention is evaluated for plaque removal efficacy, gingival health, brushing time, and patient comfort

Single-Headed Toothbrush

Participants used a conventional single-headed manual toothbrush to clean the other side of their mouth using the same brushing technique (Bass method), frequency (twice daily). This arm serves as the standard control for comparison in evaluating plaque removal and patient-reported comfort.

Group Type: ACTIVE_COMPARATOR

Conventional Single-Headed Manual Toothbrush

Intervention Type: DEVICE

A standard single-headed manual toothbrush used as the active control. Participants used this toothbrush on the other side of the mouth, with the same brushing technique (Bass method), frequency (twice daily). It serves as the comparator for assessing the performance of the dual-headed design.

Interventions

Dual-Headed Manual Toothbrush

A novel toothbrush with a dual-headed design intended to clean both upper and lower buccal/ or upper and lower lingual/ palatal surfaces simultaneously. Participants were instructed to use this toothbrush on one side of the mouth only, twice daily using the Bass brushing technique. This intervention is evaluated for plaque removal efficacy, gingival health, brushing time, and patient comfort

Intervention Type: DEVICE

Conventional Single-Headed Manual Toothbrush

A standard single-headed manual toothbrush used as the active control. Participants used this toothbrush on the other side of the mouth, with the same brushing technique (Bass method), frequency (twice daily). It serves as the comparator for assessing the performance of the dual-headed design.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• • Dentists with a minimum of 26 natural teeth, good general health, and the ability to perform routine oral hygiene independently.

• No systemic diseases affecting oral hygiene.
• Record of mild-to-moderate plaque accumulation; PI score ≥ 1
• Rt handed dentists

Exclusion Criteria

• • Participants with active periodontal disease, orthodontic appliances, or having recent oral surgery

• Those currently enrolled in any other dental trial
• Smokers.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dar Al Uloom University

OTHER

Sponsor Role: lead

Responsible Party

Sally Abd-ElMeniem ElHaddad

Assist. Prof. Periodontology and Oral Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

College of Dentistry, Dar AlUloom University

Riyadh, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Sally ElHaddad, Assist. Prof.

Role: CONTACT

s.elhaddad@dau.edu.sa

+966555361062

SREIC Scientific Research Ethics and Innovative committee

Role: CONTACT

cod.sreic@du.edu.sa

00966011494 ext. 9212

Facility Contacts

Sally ElHaddad

Role: primary

s.elhaddad@dau.edu.sa

00966555361062

Other Identifiers

34-01-2025

Identifier Type: -

Identifier Source: org_study_id