To Investigate the Clinical Efficacy of an Experimental Toothpaste

NCT01079910 | Withdrawn Phase 1

• 1 other identifier: T3450803
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingivitis

Keywords

Plaque; Toothpaste; Gingivitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

Experimental toothpaste

EXPERIMENTAL

0.1% isopropylmethylphenol and 1150ppm fluoride

Drug: isopropylmethylphenol and Fluoride

Marketed toothpaste

OTHER

NaF/Silica toothpaste containing 1150ppm fluoride

Drug: Fluoride and Silica

Interventions

isopropylmethylphenol and Fluoride DRUG

0.1% isopropylmethylphenol and 1150ppm fluoride

Experimental toothpaste

Fluoride and Silica DRUG

NaF/Silica toothpaste containing 1150ppm fluoride

Marketed toothpaste

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid

Interventions

Fluorides; Silicon Dioxide

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds; Minerals; Oxides; Oxygen Compounds; Silicon Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: March 3, 2010
• Study Start: December 9, 2009
• Primary Completion: December 10, 2009
• Study Completion: December 10, 2009
• Last Updated: July 16, 2018

Record last verified: 2018-07