Back to resultsTo Investigate the Clinical Efficacy of an Experimental Toothpaste
Primary Purpose
Gingivitis
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
isopropylmethylphenol and Fluoride
Fluoride and Silica
Sponsored by
About this trial
This is an interventional prevention trial for Gingivitis focused on measuring Plaque, Toothpaste, Gingivitis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental toothpaste
Marketed toothpaste
Arm Description
0.1% isopropylmethylphenol and 1150ppm fluoride
NaF/Silica toothpaste containing 1150ppm fluoride
Outcomes
Primary Outcome Measures
Change from baseline Modified Gingival Index at 24 weeks
Change from baseline Bleeding Index at 24 weeks
Secondary Outcome Measures
Change from baseline Modified Gingival Index at weeks 6 & 12
Change from baseline Bleeding Index at weeks 6 & 12
Change from baseline Plaque Index at weeks 6, 12 & 24
Change from baseline plaque bacteria at weeks 12 & 24
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01079910
Brief Title
To Investigate the Clinical Efficacy of an Experimental Toothpaste
Official Title
Clinical Efficacy of an Experimental Toothpaste
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Study Start Date
December 9, 2009 (Anticipated)
Primary Completion Date
December 10, 2009 (Anticipated)
Study Completion Date
December 10, 2009 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
Plaque, Toothpaste, Gingivitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental toothpaste
Arm Type
Experimental
Arm Description
0.1% isopropylmethylphenol and 1150ppm fluoride
Arm Title
Marketed toothpaste
Arm Type
Other
Arm Description
NaF/Silica toothpaste containing 1150ppm fluoride
Intervention Type
Drug
Intervention Name(s)
isopropylmethylphenol and Fluoride
Intervention Description
0.1% isopropylmethylphenol and 1150ppm fluoride
Intervention Type
Drug
Intervention Name(s)
Fluoride and Silica
Intervention Description
NaF/Silica toothpaste containing 1150ppm fluoride
Primary Outcome Measure Information:
Title
Change from baseline Modified Gingival Index at 24 weeks
Time Frame
baseline to 24 weeks
Title
Change from baseline Bleeding Index at 24 weeks
Time Frame
baseline to 24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline Modified Gingival Index at weeks 6 & 12
Time Frame
baseline to week 12
Title
Change from baseline Bleeding Index at weeks 6 & 12
Time Frame
baseline to week 12
Title
Change from baseline Plaque Index at weeks 6, 12 & 24
Time Frame
baseline to week 24
Title
Change from baseline plaque bacteria at weeks 12 & 24
Time Frame
baseline to week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
To Investigate the Clinical Efficacy of an Experimental Toothpaste
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