Clinical trial NCT03703245: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gingivitis
Dental Plaque
Keywords: Plaque Accumulation
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-10-11
Enrollment: 1601
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective pooled studies include healthy male and non-pregnant, non-lactating female subjects at least 18 years of age, with pre-existing gingivitis as determined by an appropriately qualified clinical examiner

Brief summary: 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.

Detailed description: This pooled analysis was performed on data collated from six GSK studies that provide efficacy data supporting the twice-daily use of a dentifrice containing 67% w/w sodium bicarbonate in the management of pre-existing gingivitis, and plaque accumulation. Six studies that were chosen for inclusion in the pooled analysis were single-center, examiner-blind, 2 to 3 treatments, parallel group, stratified and randomized clinical study. In all studies, participants entered the screening period during which eligibility for the study was determined. The participants included male and non-pregnant, non-lactating female subjects at least 18 years of age with pre-existing gingivitis as determined by an appropriately qualified clinical examiner. Participants meeting the inclusion criteria entered an acclimatization period in order to minimize any potential placebo response. Participants were randomized into treatments, parallel group, stratified and randomized clinical studies twice daily at home for 6, 12 and 24 weeks and participants returned to the site. Participants underwent a full OST examination and the recording of any Adverse Events (AEs). Participants then underwent Modified Gingival Index (MGI), Bleeding Index (BI), Gingival Severity Index (GSI) followed by dental plaque assessments.

Eligibility 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

Primary outcomes:
measure: Mean number of Bleeding Sites over 24 weeks
timeFrame: Over 24 weeks
Secondary outcomes:
measure: Mean Bleeding Index (BI) over 24 weeks
timeFrame: Over 24 weeks
measure: Mean Modified Gingival Index (MGI) over 24 weeks
timeFrame: Over 24 weeks
measure: Mean Turesky modification of the Quigley Hein plaque index (TPI) over 24 weeks
timeFrame: Over 24 weeks
Other outcomes:
Locations:
city: Weybridge
country: United Kingdom
facility: GSK Investigational Site
state: Surrey
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: