To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms

NCT ID: NCT02207400

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-25
• Study Completion Date: 2015-04-30

Brief Summary

This study will compare the Gingival Bleeding and Gingival Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be conducted at Salus Research, Inc. Participants will be recruited from their database and by use of an external recruitment agency

Detailed Description

This study will be a single-centre, examiner blind, two treatment, parallel group, stratified (by baseline number of bleeding sites smoking status and bacterial sampling) randomized clinical study. At the screening visit, following provision of written informed consent, eligible participants will be provided with a standard toothpaste and toothbrush for brushing once in at the clinic and for approximately one week use at home until the baseline visit. Participants will be asked to abstain from brushing over a 12 hour period prior to the Baseline visit. At the baseline visit an oral soft tissue (OST) assessment, Modified Gingival Index (MGI) and Bleeding Index (BI), and then dental plaque assessment will be performed. Participants will be stratified according to their baseline number of bleeding sites, smoking status and whether selected for bacterial sampling. Participants will be then randomized into one of two treatment groups. After using, their assigned treatment twice daily at home for 6 weeks (visit 3), 12 weeks (visit 4) and 24 weeks (visit 5), participants will return to the site with overnight plaque at approximately the same time of day as the Baseline visit if possible. Participants will undergo a full OST examination and the recording of any Adverse Events (AEs). Participants will then undergo MGI, BI followed by dental plaque assessment. Microbiological samples will be collected on a subset of 50 participants (Determined by first 50 participants randomized).

Conditions

Oral Hygiene

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Dentifrice

Participants were advised to brush their teeth with experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride

Group Type: EXPERIMENTAL

Sodium bicarbonate and sodium fluoride

Intervention Type: DRUG

Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride

Reference Dentifrice

Participants were advised to brush their teeth with reference dentifrice containing 1100ppm fluoride as sodium fluoride

Group Type: ACTIVE_COMPARATOR

Sodium fluoride

Intervention Type: DRUG

Comparator toothpaste containing 1100 ppm fluoride as sodium fluoride

Interventions

Sodium bicarbonate and sodium fluoride

Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride

Intervention Type: DRUG

Sodium fluoride

Comparator toothpaste containing 1100 ppm fluoride as sodium fluoride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination.
• A minimum of 20 permanent gradable teeth
• Moderate gingivitis present at the screening visit in the opinion of the investigator
• A total of 20 bleeding sites or greater at baseline visit
• Positive response to bleeding on brushing present at the screening visit

Exclusion Criteria

• Pregnant or breast feeding women
• Tobacco chewers
• Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the participant unlikely to fully complete the study or any that increases the risk to the participant or undermines the data validity.
• Recent history (within the last year) of alcohol or other substance abuse
• Participants requiring prophylactic antibiotic treatment prior to dental therapy
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
• Have current active caries or any medical conditions which may directly influence gingival bleeding
• Use of concomitant or any systemic medication that, in the opinion of the investigator, might interfere with the outcome of the study or have an effect on gingival conditions within 14 days of gingival examinations
• Excessive calculus present that interferes with the probing examination for Gingival Bleeding Index
• Participation in another clinical study or receipt of an investigational drug or oral care product within 30 days of the screening visit
• An employee of the sponsor or the study site or members or their immediate family.

• 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

Fort Wayne, Indiana, United States

Countries

United States

References

Jose A, Pratten J, Bosma ML, Milleman KR, Milleman JL, Wang N. Six-Month Evaluation of a Sodium Bicarbonate-Containing Toothpaste for Reduction of Established Gingivitis: A Randomized USA-Based Clinical Trial. J Clin Dent. 2018 Mar;29(1):33-39.

Reference Type: DERIVED

PMID: 29758155 (View on PubMed)

Other Identifiers

RH02434

Identifier Type: OTHER

Identifier Source: secondary_id

202193

Identifier Type: -

Identifier Source: org_study_id