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
Finalized
Finalized
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:
Other: Sodium bicarbonate
Other: Control Dentifrice
Enrollment:
1601
Observational study model:
Other
Primary completion date:
2019-11-11
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
Finalized
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
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