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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This study has been withdrawn prior to enrollment.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

February 18, 2010
March 15, 2012
Not Provided
Not Provided
  • 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 ]
Same as current
Complete list of historical versions of study NCT01079910 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Clinical Efficacy of an Experimental Toothpaste
Clinical Efficacy of an Experimental Toothpaste

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Gingivitis
  • Drug: isopropylmethylphenol and Fluoride
    0.1% isopropylmethylphenol and 1150ppm fluoride
  • Drug: Fluoride and Silica
    NaF/Silica toothpaste containing 1150ppm fluoride
  • Experimental: Experimental toothpaste
    0.1% isopropylmethylphenol and 1150ppm fluoride
    Intervention: Drug: isopropylmethylphenol and Fluoride
  • Marketed toothpaste
    NaF/Silica toothpaste containing 1150ppm fluoride
    Intervention: Drug: Fluoride and Silica
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01079910
T3450803
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP