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

NCT ID: NCT03703245

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1601 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-17
• Study Completion Date: 2019-11-11

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.

Conditions

Gingivitis; Dental Plaque

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Experimental Dentifrice

Participants were advised to brush their teeth twice daily with a full strip of experimental dentifrice containing 67% w/w sodium bicarbonate in 3 studies and additionally 62% w/w sodium bicarbonate in 3 studies covering the entire head of the toothbrush for 1 minute.

Sodium bicarbonate

Intervention Type: OTHER

Experimental dentifrice containing 67% w/w sodium bicarbonate in 3 studies and additionally 62% w/w sodium bicarbonate in 3 studies.

Control Dentifrice

Participants were advised to brush their teeth with control dentifrice containing 0% w/w sodium bicarbonate covering the entire head of the toothbrush for 1 minute.

Control Dentifrice

Intervention Type: OTHER

Negative control dentifrice containing 0% w/w sodium bicarbonate

Interventions

Sodium bicarbonate

Experimental dentifrice containing 67% w/w sodium bicarbonate in 3 studies and additionally 62% w/w sodium bicarbonate in 3 studies.

Intervention Type: OTHER

Control Dentifrice

Negative control dentifrice containing 0% w/w sodium bicarbonate

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Weybridge, Surrey, United Kingdom

Countries

United Kingdom

Other Identifiers

209509

Identifier Type: -

Identifier Source: org_study_id