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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-40
SponsorDar Al Uloom University

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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

Disqualifiers

• Participants with active periodontal disease, orthodontic appliances, or having recent oral surgery

Those currently enrolled in any other dental trial

Smokers.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Dual-Headed ToothbrushExperimental treatment 1 intervention
Group B: Single-Headed ToothbrushActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
After 2, and 4 weeks of brushing
2

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.

Time frame
after 2 and 4 weeks
3

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.

Time frame
after 2, and 4 weeks

Secondary outcomes

1

Brushing Time Per Side

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.

Time frame
Self-reported after 4 weeks
2

Patient satisfaction and comfort

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

Time frame
after 4 weeks

Other outcomes

Sponsors and contacts

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