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

Dar Al Uloom University

Status: Enrolling

Conditions: Dental Plaque Accumulation; Toothbrushing; Oral Hygiene Education Methods

Treatments: Device: Dual-Headed Manual Toothbrush; Device: Conventional Single-Headed Manual Toothbrush

Study type: Interventional

Funder types: Other

Identifiers

NCT07030088

34-01-2025

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 25 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Dual-Headed Toothbrush

Experimental group

Description:

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.

Treatment:

Device: Dual-Headed Manual Toothbrush

Single-Headed Toothbrush

Active Comparator group

Description:

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.

Treatment:

Device: Conventional Single-Headed Manual Toothbrush