NCT07030088

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

Clinical and Patient-Based Evaluation of a Novel Dual-Headed Toothbrush Design: Split-Mouth Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Dar Al Uloom University · Academic / Other
• Sex: All
• Age: 25 Years – 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-06-19
• Last updated: 2025-09-11

Locations

1 site across 1 country: Saudi Arabia