A Clinical Study to Evaluate the Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Plaque Index of Test Mouth Rinse Versus Sterile Water After Day 4 of Treatment Administration
Study Overview
Brief Summary
A clinical study to evaluate the effect of a commercial mouth rinse on plaque re-growth
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Good general and oral health
- •At least 20 natural gradable teeth
- •Mean plaque score (Turesky Modification of the Quigley Hein Index) of greater than or equal to 2.00 at the first baseline visit
Exclusion Criteria
- Not provided
Arms & Interventions
Sterile Water
Sterile Water
Intervention: Sterile water (Other)
0.12% Chlorhexidine Mouthrinse
Commercially available 0.12% Chlorhexidine mouthrinse
Intervention: 0.12% chlorhexidine mouthrinse (Drug)
Cosmetic mouthrinse
Commercially available cosmetic mouthrinse
Intervention: Cosmetic mouthrinse (Other)
Outcomes
Primary Outcomes
Plaque Index of Test Mouth Rinse Versus Sterile Water After Day 4 of Treatment Administration
Time Frame: Day 4 post treatment administration
Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.
Secondary Outcomes
- Plaque Index Score of Test Mouth Rinse Versus Chlorhexidine Mouth Rinse After Day 4 of Treatment Administration(Day 4 post treatment administration)
- Plaque Index After 24 Hours of Treatment Administration(Day 1 post treatment administration)
- Interproximal Plaque Index After Day 4 of Treatment Administration(Day 4 post treatment administration)
- Interproximal Plaque Index After 24 Hours of Treatment Administration(Day 1 post treatment administration)