To Investigate the Clinical Efficacy of an Experimental Toothpaste

GlaxoSmithKline (GSK)

Status and phase: Withdrawn; Phase 1

Conditions: Gingivitis

Treatments: Drug: Fluoride and Silica; Drug: isopropylmethylphenol and Fluoride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01079910

T3450803

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Experimental toothpaste

Experimental group

Description:

0.1% isopropylmethylphenol and 1150ppm fluoride

Treatment:

Drug: isopropylmethylphenol and Fluoride

Marketed toothpaste

Other group

Description:

NaF/Silica toothpaste containing 1150ppm fluoride

Treatment:

Drug: Fluoride and Silica