To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste

NCT02207907 | Completed Phase 2 Results

• 2 other identifiers: 202192RH02433
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives of this study will be to 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 Silverstone Research Group. Participants will be recruited from their database and by use of an external recruitment agency.

Conditions

Oral Hygiene

Outcome Measures

Primary Outcomes (2)

• Number of Gingival Bleeding Sites at 24 Weeks

  Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (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.

  Baseline, 24 weeks

• Modified Gingival Index (MGI) at 24 Weeks

  The Modified Gingival Index (MGI) was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration

  Baseline, 24 weeks

Secondary Outcomes (4)

• Number of Gingival Bleeding Sites at 6 and 12 Weeks.

  Baseline, 6 and 12 weeks

• Modified Gingival Index (MGI) at 6 and 12 Weeks.

  Baseline, 6 and 12 weeks

• Bleeding Index at 6, 12 and 24 Weeks

  Baseline, 6, 12 and 24 weeks

• Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.

  Baseline, 6,12 and 24 weeks

Study Arms (2)

Sodium bicarbonate plus sodium fluoride

EXPERIMENTAL

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

Drug: Sodium bicarbonate plus sodium fluoride

Sodium fluoride

ACTIVE COMPARATOR

Toothpaste containing 1100 ppm fluoride as sodium fluoride

Drug: Sodium fluoride

Interventions

Sodium bicarbonate plus sodium fluoride DRUG

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

Sodium bicarbonate plus sodium fluoride

Sodium fluoride DRUG

Toothpaste containing 1100 ppm fluoride as sodium fluoride

Sodium fluoride

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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 participants 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Las Vegas, Nevada, 89146, United States

Location

MeSH Terms

Interventions

Sodium Bicarbonate; Sodium Fluoride

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Fluorides; Hydrofluoric Acid; Fluorine Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 4, 2014
• Study Start: August 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 13, 2017
• Results First Posted: February 17, 2017

Record last verified: 2016-12

Locations

US (1)