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 volunteersQualifiers
• 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
Parallel
Treatments tested in this trial
Dual-Headed Manual Toothbrush
DeviceA 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
DeviceA 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
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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.
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
Sponsors and contacts
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