Last updated: 04/03/2020 12:00:12
A phase 3 clinical study investigating the gingivitis efficacy of a test dentifrice containing stannous fluoride
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice
Trial description: The purpose of this study is to evaluate and compare the gingival health of a test dentifrice (0.454% weight by weight [w/w] stannous fluoride) to a negative control dentifrice by comparing modified gingival index, bleeding index and plaque index scores.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Evaluation and comparison of gingival health measured by Bleeding Index (BI) after 24 weeks
Timeframe: At Week 24
Secondary outcomes:
Evaluation and comparison of gingival health measured by Bleeding Index (BI) after 12 weeks
Timeframe: At Week 12
Evaluation and comparison of gingival health measured by Modified Gingival Index (MGI) after 12 and 24 weeks.
Timeframe: At Week 12 and Week 24
Evaluation and comparison of supra-gingival plaque levels measured by Plaque Index (PI) after 12 and 24 weeks.
Timeframe: At Week 12 and Week 24
Evaluation and comparison of MGI and BI indices in low and high MGI subgroups (<=2.00 and >2.00, respectively) after 12 and 24 weeks.
Timeframe: At Week 12 and Week 24
Interventions:
Enrollment:
98
Primary completion date:
2013-11-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Gingivitis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
May 2013 to December 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Consent :Demonstrates understanding of the study and willingness to participate as
- evidenced by voluntary written informed consent and has received a signed
- Pregnancy and breast-feeding: Women who are known to be pregnant or who are intending to become pregnant or women who are breast-feeding over the duration of the study.
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Inclusion and exclusion criteria
Inclusion criteria:
- Consent :Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
- General Health: Good general and mental health with, in the opinion of the investigator, no clinically significant and relevant abnormalities of medical history or oral examination. -Dental Health: A minimum of 20 natural teeth and a minimum of 40 gradable surfaces for: a) MGI, BI and PI. A scorable surface is defined as a surface that has 50% of the surface gradable. Third molars, orthodontically banded/ bonded, fully crowned or extensively restored or grossly carious teeth are not included in the tooth count; b) Moderate gingivitis present at the screening visit in the opinion of the investigator; c) Mean whole mouth MGI between 1.75 and 2.30 and mean whole mouth supra-gingival PI score 1.5 at Baseline Visit.
Exclusion criteria:
- Pregnancy and breast-feeding: Women who are known to be pregnant or who are intending to become pregnant or women who are breast-feeding over the duration of the study.
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Tobacco Use: Current smokers or smokers who have quit within the past six months, prior to screening, or participants currently using smokeless forms of tobacco
- e.g. chewing tobacco.
- Concomitant Medications
- Treatments Screening (Visit 1) a) Currently taking antibiotics or requiring antibiotic use prior to dental prophylaxis or other dental procedures. b) Currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition. c) Currently taking a systemic medication which, in the opinion of the Investigator, could affect gingival condition (e.g. calcium channel blockers, or aspirin therapy). d) Current use of a chlorhexidine mouthwash. Baseline (Visit 2) e) Currently taking antibiotics or taken antibiotics in the previous 14 days or requiring antibiotic use prior to dental prophylaxis or other dental procedures. f) Has taken an anti-inflammatory medication which, in the opinion of the investigator, could affect gingival condition in the previous 14 days. g) Has taken a systemic medication which, in the opinion of the investigator, could affect gingival condition in the previous 14 days (e.g. calcium channel blockers, or aspirin therapy).
- General Dentition Exclusions a) Current active caries or periodontitis that may, in the opinion of the investigator, compromise the study outcomes or oral health of the participants if they participate in the study. b) Restorations in a poor state of repair. c) Partial dentures or orthodontic appliances. d) Teeth bleaching within 12 weeks of screening.
- Clinical Study/Experimental Medication a) Participation in another clinical study or receipt of an investigational drug or investigational oral care product within 30 days of the Baseline Visit. b) Previous participation in this study.
- Substance abuse: Recent history (within the last year) of alcohol or other substance abuse.
- Personnel: a) Employed by the sponsor or the study site or members of their immediate family. b) Employed by any dentifrice manufacturer or their immediate family.
- Other Conditions: Any condition that would impact on the safety of the participant or wellbeing or affect the individual’s ability to understand and follow study procedures and requirements.
Trial location(s)
Location
GSK Investigational Site
Fort Wayne, Indiana, United States, 46825
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2013-11-12
Actual study completion date
2013-11-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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