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Clinical Efficacy of an Experimental Toothpaste

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01079910
First received: February 18, 2010
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Gingivitis
 Drug: isopropylmethylphenol and Fluoride
Drug: Fluoride and Silica
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Clinical Efficacy of an Experimental Toothpaste

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline Modified Gingival Index at 24 weeks [ Time Frame: baseline to 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline Bleeding Index at 24 weeks [ Time Frame: baseline to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline Modified Gingival Index at weeks 6 & 12 [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
  • Change from baseline Bleeding Index at weeks 6 & 12 [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
  • Change from baseline Plaque Index at weeks 6, 12 & 24 [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
  • Change from baseline plaque bacteria at weeks 12 & 24 [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
Experimental: Experimental toothpaste
0.1% isopropylmethylphenol and 1150ppm fluoride
 Drug: isopropylmethylphenol and Fluoride
0.1% isopropylmethylphenol and 1150ppm fluoride
Marketed toothpaste
NaF/Silica toothpaste containing 1150ppm fluoride
 Drug: Fluoride and Silica
NaF/Silica toothpaste containing 1150ppm fluoride

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079910

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01079910     History of Changes
Other Study ID Numbers: T3450803
Study First Received: February 18, 2010
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Plaque
Toothpaste
Gingivitis

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
 Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013