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

NCT03703245 | Completed

• 1 other identifier: 209509
• Study Type: observational
• Target: 1,601
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis; Dental Plaque

Keywords

Plaque Accumulation

Outcome Measures

Primary Outcomes (1)

• Mean number of Bleeding Sites over 24 weeks

  Number of gingival bleeding sites were measured as BI via a single examiner using a color coded periodontal probe. The probe was gently inserted approximately 1 millimeter (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2. This measure will be analyzed and summarized over all sites and at the tooth site level.

  Over 24 weeks

Secondary Outcomes (3)

• Mean Bleeding Index (BI) over 24 weeks

  Over 24 weeks

• Mean Modified Gingival Index (MGI) over 24 weeks

  Over 24 weeks

• Mean Turesky modification of the Quigley Hein plaque index (TPI) over 24 weeks

  Over 24 weeks

Study Arms (2)

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.

Other: Sodium bicarbonate

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.

Other: Control Dentifrice

Interventions

Sodium bicarbonate OTHER

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

Experimental Dentifrice

Control Dentifrice OTHER

Negative control dentifrice containing 0% w/w sodium bicarbonate

Control Dentifrice

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Clinical studies conducted by GSK CH, including access to study protocols, study reports, and access to individual information sources/ study data.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Weybridge, Surrey, United Kingdom

Location

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: October 11, 2018
• Study Start: April 17, 2019
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

GB (1)