Evaluation of Toothbrush Bristles
ConditionGingivitis and Periodontal Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorState University of New York at Buffalo
About this trial
The goal of this randomized clinical trial is to investigate two different types of toothbrush bristles.
The main questions it aims to answer are the effects of two different bristle types on:
* how much plaque is on the teeth * how deep the space is between gums and teeth * how much gum and bone are attached to the teeth * whether the gums bleed when checked * if the gums get scratched or irritated
Researchers will compare toothbrushes with tapered bristles to those with regular round bristles.
Participants will be randomly assigned toothbrush A or B to use at home during the study.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Must have read, understood and signed an informed consent prior to being entered into the study.
Must be 18 to 70 years of age, male or female.
Have at least 20 natural or restored teeth, not including implants.
Must have average Plaque Index of greater than 2 at screening.
Disqualifiers
Physical limitations or restrictions that might preclude normal tooth brushing.
Evidence of gross oral pathology
Periodontal probing pocket depths (PPD) ≥ 5mm.
Evidence of major soft tissue lesions or trauma at the baseline visit as determined by the examiner.
Trial design
Design model
Parallel
Treatments tested in this trial
Toothbrush with tapered bristles
Other interventionToothbrush with tapered bristles
Toothbrush with end-rounded bristles
Other interventionToothbrush with end-rounded bristles
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Product AOther 1 intervention
Group B: Product BOther 1 intervention
Trial outcomes
Primary outcomes
1
Rustogi Modified Navy Plaque Index
Measured before and after on-site brushing to compare the frequency of plaque presence before and after brushing, as well as cumulative effects of brushing over 2 and 4 weeks. Plaque index is recorded as "1", meaning plaque is present or "0", meaning no plaque is present.
Time frame
Baseline, Week 2 and Week 4Secondary outcomes
1
Gingival Abrasion Score
Measured before and after on-site brushing and categorized based on abrasion size (small, medium, large) to assess the one-time brushing effects as well as the cumulative effects of brushing over 2 and 4 weeks. Abrasion sizes are measured in millimeters and categorized as small (≤2 mm), medium (3-5 mm), and large (\>5 mm). Measurements between 2 and 3 mm are assigned a score of small or medium according to nearest mm mark. Higher scores indicate a worse outcome than a low score, or no score (no abrasion).
Time frame
Baseline, Week 2, and Week 4Other outcomes
1
Bleeding on Probing
Measured before and after on-site brushing to assess the one-time brushing effects as well as the cumulative effects of brushing over 2 and 4 weeks.
Time frame
Baseline, Week 2, Week 42
Periodontal Probing Depth and Clinical Attachment Loss
PPD and CAL will be determined at six sites per tooth (mesio-facial, mid facial, disto-facial, disto-lingual, mid lingual, and mesio-lingual) to assess changes over 4 week study period.
Time frame
Baseline, Week 2 and Week 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov