Last updated: 01/06/2021 04:10:06
To investigate the gingivitis efficacy of a Stannous Fluoride Dentifrice in a Chinese Population
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Clinical Study Investigating the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population.
Trial description: This single-centre, examiner-blind, randomized, stratified, two-treatment, parallel group clinical study will evaluate the efficacy of a 0.454% w/w stannous fluoride dentifrice compared to a reference dentifrice to control gingivitis (gingival bleeding and visual signs of gingival inflammation) in dentally and periodontally healthy adult volunteers over 12 weeks use in a Chinese population.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Mean Bleeding Index (BI)
Timeframe: At Week 12
Secondary outcomes:
Number of bleeding sites
Timeframe: At Week 12
Mean Modified Gingival Index (MGI)
Timeframe: At Week 12
Mean Plaque Index (PI) (overall and interproximal)
Timeframe: At Week 12
Interventions:
Other: Stannous fluoride
Other: Sodium monofluorophosphate
Enrollment:
128
Observational study model:
Not applicable
Primary completion date:
2017-22-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Gingivitis
Product
GSK3730661, SKF46655, SKF46656, sodium fluoride
Collaborators
Not applicable
Study date(s)
September 2017 to December 2017
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Aged 18 to 65 years.
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding
Inclusion and exclusion criteria
Inclusion criteria:
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Aged 18 to 65 years.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon oral examination, absence of any condition that would impact on the participant’s safety or wellbeing or affect the individual’s ability to understand and follow study procedures and requirements.
- A minimum of 20 natural teeth (all teeth; incisors, canines, pre-molars & molars), and a minimum of 40 gradable surfaces for MGI, BI and PI. A scorable surface is defined as a surface that has 50% of the surface gradable for each clinical index. Third molars, orthodontically banded/bonded, fully crowned or extensively restored or grossly carious teeth are not included in the tooth count, moderate gingivitis present at the screening visit (in the opinion of the clinical examiner from a gross visual examination) and mean whole mouth MGI between 1.75 and 2.30 and a mean overall PI score >1.5 at Baseline visit.
Exclusion criteria:
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Screening: Currently taking antibiotics or requiring antibiotic use prior to dental prophylaxis or other dental procedures, currently taking an anti-inflammatory medication or traditional Chinese medicines (TCM) which, in the opinion of the Investigator, could affect gingival condition, currently taking a systemic medication which, in the opinion of the Investigator, could affect gingival condition (e.g. calcium channel blockers, or aspirin therapy).
- Baseline (Visit 2): Has taken, or currently taking, antibiotics in the previous 14 days, or an anti-inflammatory medication or a systemic medication days (e.g. calcium channel blockers, or aspirin therapy) which, in the opinion of the Investigator, could affect gingival condition in the previous 14 days.
- Have current active caries or periodontitis that may, in the opinion of the investigator, compromise the study or the oral health of the participants if they participate in the study, restorations in a poor state of repair, partial dentures or orthodontic appliances, teeth bleaching within 12 weeks of screening and use of a chlorhexidine mouthwash currently, or within 14 days of baseline.
- Participation in another clinical study or receipt of an investigational drug or investigational oral care product within 30 days of Baseline (Visit 2) and previous participation in this study.
- Recent history (within the last year) of alcohol or other substance abuse.
- An employee of the sponsor or the study site or members of their immediate family and employed by any dentifrice manufacturer or their immediate family.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Protocol
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
Completed
Actual primary completion date
2017-22-12
Actual study completion date
2017-22-12
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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