Last updated: 07/29/2020 08:10:14
Pooled Analysis of Clinical Data from six GSK studies to investigate the Efficacy of a Dentifrice containing 67% weight by weight (w/w) Sodium Bicarbonate on Gingivitis and Plaque Accumulation
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Post-hoc Pooled Analysis of GSK CH Clinical Data Investigating the Efficacy of a Dentifrice containing 67% w/w Sodium Bicarbonate on Gingivitis and Plaque Accumulation
Trial description: The aim of this analysis was to pool data from 6 GSK studies with similar clinical design to investigate the overall efficacy of a test dentifrice containing 67% w/w sodium bicarbonate in the treatment of gingivitis and plaque accumulation after 6, 12 and 24 weeks of twice-daily brushing at home relative to a negative control dentifrice. The pooled analysis was planned and conducted after completion of all six independent studies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Mean number of Bleeding Sites over 24 weeks
Timeframe: Over 24 weeks
Secondary outcomes:
Mean Bleeding Index (BI) over 24 weeks
Timeframe: Over 24 weeks
Mean Modified Gingival Index (MGI) over 24 weeks
Timeframe: Over 24 weeks
Mean Turesky modification of the Quigley Hein plaque index (TPI) over 24 weeks
Timeframe: Over 24 weeks
Interventions:
Enrollment:
1601
Primary completion date:
2019-11-11
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Gingivitis
Product
GSK3413212, sodium bicarbonate, sodium fluoride
Collaborators
Not applicable
Study date(s)
April 2019 to November 2019
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Clinical studies conducted by GSK CH, including access to study protocols, study reports, and access to individual information sources/ study data.
- Study design and subject inclusion criteria in agreement with guidelines to assess gingivitis efficacy such as inclusion of a pre-treatment full-mouth prophylaxis, Subject eligibility (>20 bleeding sites and mild-moderate gingivitis at Screening);Comparable indices of gingivitis and plaque accumulation; a treatment for a 67% w/w sodium bicarbonate dentifrice; Repeat brushing for at least a period of 4 weeks or 4-6 weeks.
- Not Applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Clinical studies conducted by GSK CH, including access to study protocols, study reports, and access to individual information sources/ study data.
- Study design and subject inclusion criteria in agreement with guidelines to assess gingivitis efficacy such as inclusion of a pre-treatment full-mouth prophylaxis, Subject eligibility (>20 bleeding sites and mild-moderate gingivitis at Screening);Comparable indices of gingivitis and plaque accumulation; a treatment for a 67% w/w sodium bicarbonate dentifrice; Repeat brushing for at least a period of 4 weeks or 4-6 weeks.
Exclusion criteria:
- Not Applicable
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2019-11-11
Actual study completion date
2019-11-11
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website