To Investigate the Clinical Efficacy of an Experimental Toothpaste

GlaxoSmithKline

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Conditions

Gingivitis

Interventions

isopropylmethylphenol and FluorideDRUG

0.1% isopropylmethylphenol and 1150ppm fluoride

Fluoride and SilicaDRUG

NaF/Silica toothpaste containing 1150ppm fluoride

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change from baseline Modified Gingival Index at 24 weeks

Time frame: baseline to 24 weeks

Change from baseline Bleeding Index at 24 weeks

Time frame: baseline to 24 weeks

Secondary Outcomes

Change from baseline Modified Gingival Index at weeks 6 & 12

Time frame: baseline to week 12

Change from baseline Bleeding Index at weeks 6 & 12

Time frame: baseline to week 12

Change from baseline Plaque Index at weeks 6, 12 & 24

Time frame: baseline to week 24

Change from baseline plaque bacteria at weeks 12 & 24

Time frame: baseline to week 24

Data from ClinicalTrials.gov

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