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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,601 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gingivitis
• Dental Plaque

Interventions

Type	Name	Description
OTHER	Sodium bicarbonate	Experimental dentifrice containing 67% w/w sodium bicarbonate in 3 studies and additionally 62% w/w sodium bicarbonate in 3 studies.
OTHER	Control Dentifrice	Negative control dentifrice containing 0% w/w sodium bicarbonate

Timeline

• Start date: 2019-04-17
• Primary completion: 2019-11-11
• Completion: 2019-11-11
• First posted: 2018-10-11
• Last updated: 2020-01-18

Locations

1 site across 1 country: United Kingdom