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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Oral Hygiene

Treatments: Drug: Sodium fluoride; Drug: Sodium bicarbonate and sodium fluoride

Study type: Interventional

Funder types: Industry

Identifiers

NCT02207400

RH02434 (Other Identifier)

202193

Details and patient eligibility

About

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

Full 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).

Enrollment: 246 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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246 participants in 2 patient groups

Experimental Dentifrice

Experimental group

Description:

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

Treatment:

Drug: Sodium bicarbonate and sodium fluoride

Reference Dentifrice

Active Comparator group

Description:

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

Treatment:

Drug: Sodium fluoride