Gingivitis and Periodontal Diseases
Conditions
Brief summary
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.
Interventions
OTHERToothbrush with tapered bristles
Toothbrush with tapered bristles
OTHERToothbrush with end-rounded bristles
Toothbrush with end-rounded bristles
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. * Must have more than 20% of pockets with bleeding on probing at screening. * Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures any time during the study. * Agree to refrain from regular oral hygiene regimen for 24 hours and eating for 4 hours before the appointment in the study. * Agree to abstain from the use of any dental products other than those provided in the study. * Agree to comply with the conditions and schedule of the study.
Exclusion criteria
* 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. * Chronic disease with concomitant oral manifestations * Subjects who are currently undergoing, or require, extensive dental work, orthodontic treatment or periodontal surgery, or orthodontic treatment in the preceding 3 months * Currently using bleaching trays * Eating disorders * Recent history of substance abuse * Smoking \>10 cigarettes/day * Participation in other clinical studies within 14 days of screening * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rustogi Modified Navy Plaque Index | Baseline, Week 2 and Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Abrasion Score | Baseline, Week 2, and Week 4 | 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). |
Countries
United States
Contacts
CONTACTSenior Clinical Research Coordinator, Bachelor of Science
PRINCIPAL_INVESTIGATORMarcelle Nascimento, DDS, MS, PhD
State University of New York at Buffalo
Outcome results
None listed