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

NCT07030088 | Recruiting DMC

• 1 other identifier: 34-01-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Plaque Accumulation; Oral Hygiene Education Methods; Toothbrushing

Keywords

Dual-headed toothbrush; Single-headed toothbrush; Toothbrushing technique

Outcome Measures

Primary Outcomes (3)

• Change in Plaque Index (PI)

  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.

  After 2, and 4 weeks of brushing

• Gingival Index (GI)

  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.

  after 2 and 4 weeks

• mSBI (modified sulcular bleeding index)

  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.

  after 2, and 4 weeks

Secondary Outcomes (2)

• Brushing Time Per Side

  Self-reported after 4 weeks

• Patient satisfaction and comfort

  after 4 weeks

Study Arms (2)

Dual-Headed Toothbrush

EXPERIMENTAL

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.

Device: Dual-Headed Manual Toothbrush

Single-Headed Toothbrush

ACTIVE COMPARATOR

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.

Device: Conventional Single-Headed Manual Toothbrush

Interventions

Dual-Headed Manual Toothbrush 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

Dual-Headed Toothbrush

Conventional Single-Headed Manual Toothbrush 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.

Single-Headed Toothbrush

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Participants with active periodontal disease, orthodontic appliances, or having recent oral surgery
• Those currently enrolled in any other dental trial
• Smokers.

Sponsors & Collaborators

• Dar Al Uloom University: lead

Study Sites (1)

College of Dentistry, Dar AlUloom University

Riyadh, 11512, Saudi Arabia

RECRUITING

Central Study Contacts

Sally ElHaddad, Assist. Prof.

CONTACT

+966555361062; s.elhaddad@dau.edu.sa

SREIC Scientific Research Ethics and Innovative committee

CONTACT

00966011494; cod.sreic@du.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Periodontology and Oral Medicine

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 19, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

SA (1)