To Investigate the Clinical Efficacy of an Experimental Toothpaste

Gingivitis Clinical Trial

Official title:

Clinical Efficacy of an Experimental Toothpaste

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01079910
• Other study ID #: T3450803
• Status: Withdrawn
• Phase: Phase 1
• Start date: December 9, 2009
• Est. completion date: December 10, 2009

Study information

• Verified date: July 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 10, 2009
• Est. primary completion date: December 10, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• isopropylmethylphenol and Fluoride
0.1% isopropylmethylphenol and 1150ppm fluoride
• Fluoride and Silica
NaF/Silica toothpaste containing 1150ppm fluoride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Modified Gingival Index at 24 weeks		baseline to 24 weeks
Primary	Change from baseline Bleeding Index at 24 weeks		baseline to 24 weeks
Secondary	Change from baseline Modified Gingival Index at weeks 6 & 12		baseline to week 12
Secondary	Change from baseline Bleeding Index at weeks 6 & 12		baseline to week 12
Secondary	Change from baseline Plaque Index at weeks 6, 12 & 24		baseline to week 24
Secondary	Change from baseline plaque bacteria at weeks 12 & 24		baseline to week 24