Clinical Efficacy of an Experimental Toothpaste
Overview
- Phase
- Phase 1
- Intervention
- isopropylmethylphenol and Fluoride
- Conditions
- Gingivitis
- Sponsor
- GlaxoSmithKline
- Primary Endpoint
- Change from baseline Bleeding Index at 24 weeks
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Experimental toothpaste
0.1% isopropylmethylphenol and 1150ppm fluoride
Intervention: isopropylmethylphenol and Fluoride
Marketed toothpaste
NaF/Silica toothpaste containing 1150ppm fluoride
Intervention: Fluoride and Silica
Outcomes
Primary Outcomes
Change from baseline Bleeding Index at 24 weeks
Time Frame: baseline to 24 weeks
Change from baseline Modified Gingival Index at 24 weeks
Time Frame: baseline to 24 weeks
Secondary Outcomes
- 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)