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NCT Number: NCT07030088

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

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

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Key information

Conditions

Dental Plaque Accumulation Oral Hygiene Education Methods Toothbrushing

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentistry, Dar AlUloom University

Riyadh, 11512, Saudi Arabia

Location status: Recruiting

Location contact

Sally ElHaddad

CONTACT

[email protected]

00966555361062

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Change in Plaque Index (PI)

    Time frame: 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.

  2. Gingival Index (GI)

    Time frame: 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.

  3. mSBI (modified sulcular bleeding index)

    Time frame: after 2, and 4 weeks

    mSBI (modified sulcular bleeding index): 0: no bleeding when a periodontal probe is passed along the gingival margin

    • isolated bleeding spots visible
    • Blood forms a confluent red line on margin
    • Heavy or profuse bleeding

    Interpretation: Lower scores indicate better oral hygiene and effectiveness of the toothbrush.

Secondary outcomes

  1. Brushing Time Per Side

    Time frame: 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.

  2. Patient satisfaction and comfort

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

SREIC Scientific Research Ethics and Innovative committee

CONTACT

[email protected]

00966011494 ext. 9212

Sally ElHaddad, Assist. Prof.

CONTACT

[email protected]

+966555361062

Sponsors and collaborators

Lead sponsor

Dar Al Uloom University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 19, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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