To Investigate the Clinical Efficacy of an Experimental Toothpaste
Phase 1
Withdrawn
- Conditions
- Gingivitis
- Interventions
- Drug: isopropylmethylphenol and Fluoride
- Registration Number
- NCT01079910
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The objective of this study is to evaluate the effect of an experimental toothpaste on maintaining gingival health over a 24 week period measured through modified gingival index, bleeding, plaque, and plaque bacteria. Prior to commencing study treatment, subjects will undergo a dental prophylaxis followed by a 2 week period of oral hygiene instruction and weekly professional tooth cleaning to bring the subjects to their optimum gingival health prior to commencing study treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Healthy subjects aged 18 years and older
- A minimum of 20 permanent gradable teeth
- For baseline eligibility, subjects must have a minimum Modified Gingival Index score of 1.5-2.3.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental toothpaste isopropylmethylphenol and Fluoride 0.1% isopropylmethylphenol and 1150ppm fluoride Marketed toothpaste Fluoride and Silica NaF/Silica toothpaste containing 1150ppm fluoride
- Primary Outcome Measures
Name Time Method Change from baseline Bleeding Index at 24 weeks baseline to 24 weeks Change from baseline Modified Gingival Index at 24 weeks baseline to 24 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline Modified Gingival Index at weeks 6 & 12 baseline to week 12 Change from baseline Bleeding Index at weeks 6 & 12 baseline to week 12 Change from baseline Plaque Index at weeks 6, 12 & 24 baseline to week 24 Change from baseline plaque bacteria at weeks 12 & 24 baseline to week 24