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

Not Applicable

Recruiting

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

• Registration Number: NCT07030088
• Lead Sponsor: Dar Al Uloom University

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-12
• Study First Posted: 2025-06-19
• Study Start: 2025-09-01
• Last Update Submitted: 2025-09-05
• Last Update Posted: 2025-09-11
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Plaque Index (PI)	After 2, and 4 weeks of brushing	Difference in plaque scores between baseline and end of study on the left and right sides of the mouth, using the Silness and Löe Plaque Index.; Scale: 0 = No plaque, 1 = A film of plaque, 2 = Moderate plaque, 3 = Abundant plaque Interpretation: Lower scores indicate better oral hygiene and effectiveness of the toothbrush.
Gingival Index (GI)	after 2 and 4 weeks	Löe \& Silness for GI Gingival index 0: Healthy gums. Gingival index 1: Mild discolouration and oedematous gingiva. No bleeding on probing.; Gingival index 2: Red, oedematous and shiny gingiva. There is bleeding on probing.; Gingival index 3: Red, oedematous and ulcerated gingiva. There is spontaneous bleeding.; Interpretation: Lower scores indicate better oral hygiene and effectiveness of the toothbrush.
mSBI (modified sulcular bleeding index)	after 2, and 4 weeks	mSBI (modified sulcular bleeding index): 0: no bleeding when a periodontal probe is passed along the gingival margin; 1. isolated bleeding spots visible; 2. Blood forms a confluent red line on margin; 3. Heavy or profuse bleeding; Interpretation: Lower scores indicate better oral hygiene and effectiveness of the toothbrush.

Secondary Outcome Measures

Name	Time	Method
Brushing Time Per Side	Self-reported after 4 weeks	Measure: Average time (in seconds) participants took to brush each side (left and right) during the trial.; Interpretation: Shorter brushing time with equal or better plaque control is considered a favorable outcome.
Patient satisfaction and comfort	after 4 weeks	Patient satisfaction and comfort (evaluated using a Likert scale questionnaire): 5- point Likert scale: How easy or difficult is it to use the novel toothbrush?; Very difficult, Somewhat difficult , Neither difficult nor easy , Somewhat easy , Very easy

Trial Locations

Locations (1)

College of Dentistry, Dar AlUloom University; 🇸🇦 Riyadh, Saudi Arabia