Gingivitis
Conditions
Keywords
Plaque, Toothpaste, Gingivitis
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.
Interventions
DRUGisopropylmethylphenol and Fluoride
0.1% isopropylmethylphenol and 1150ppm fluoride
DRUGFluoride and Silica
NaF/Silica toothpaste containing 1150ppm fluoride
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline Modified Gingival Index at 24 weeks | baseline to 24 weeks |
| Change from baseline Bleeding Index at 24 weeks | baseline to 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed