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This study has been withdrawn prior to enrollment.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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014