Potential of Stannous Fluoride Toothpaste to Reduce Gum Disease

NCT02750943 | Completed Results

• 1 other identifier: 205045
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a single-center, 12 week, examiner-blind, randomized, stratified (gender and baseline mean whole mouth MGI score), two-treatment, parallel group, clinical study in healthy adult volunteers with moderate gingivitis. This study will evaluate the efficacy of a dentifrice containing 0.454% weight by weight (w/w) stannous fluoride to control gingivitis and gingival bleeding following 12 weeks twice daily brushing, compared to a negative control dentifrice.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• Number of Bleeding Sites at Week 12

  Number of bleeding sites was measured as bleeding index (BI) 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 was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). 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. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.

  Week 12

Secondary Outcomes (4)

• Number of Bleeding Sites at Week 4

  Week 4

• Bleeding Index (BI) at Week 4 and Week 12

  Week 4, Week 12

• Modified Gingival Index (MGI) at Week 4 and Week 12

  Week 4, Week 12

• Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12

  Week 4, Week 12

Study Arms (2)

Stannous Fluoride

EXPERIMENTAL

Participants will apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening)

Drug: Stannous Fluoride

Sodium Monofluorophosphate

ACTIVE COMPARATOR

Participants will apply a full ribbon of dentifrice containing Dentifrice containing 1000ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening)

Drug: Sodium Monofluorophosphate

Interventions

Stannous Fluoride DRUG

Dentifrice containing 0.454% w/w stannous fluoride

Stannous Fluoride

Sodium Monofluorophosphate DRUG

Dentifrice containing 1000ppm fluoride as sodium monofluorophosphate

Sodium Monofluorophosphate

Eligibility Criteria

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

You may qualify if:

• Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
• Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination.
• Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
• A minimum of 20 permanent gradable teeth. (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded).
• Moderate gingivitis present at the screening visit in the opinion of the investigator from a gross visual gingival assessment.
• Visible blood in toothpaste expectorant at Screening and Baseline (Visit 2).

You may not qualify if:

• Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
• Women who are breast-feeding
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
• Previous participation in this study.
• Recent history (within the last year) of alcohol or other substance abuse.
• An employee of the sponsor or the study site or members of their immediate family.
• An employee of any toothpaste manufacturer or their immediate family.
• Medical History/Current Medication A. 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 subject unlikely to fully complete the study or any that increases the risk to the subject or undermines the data validity B.Screening i. Currently taking antibiotics or requiring antibiotic use prior to dental prophylaxis or other dental procedures.
• ii. Currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition.
• iii. Currently taking a systemic medication which, in the opinion of the C. Baseline, Day 28 and Day 96 Assessment Visits i. Has taken antibiotics in the previous 14 days. ii. Has taken an anti-inflammatory medication which, in the opinion of the investigator, could affect gingival condition in the previous 14 days.
• iii. Has taken a systemic medication which, in the opinion of the investigator, could affect gingival condition in the previous 14 days (e.g. calcium channel blockers, or aspirin therapy).could affect gingival condition in the previous 14 days (e.g. calcium channel blockers, or aspirin therapy).Investigator, could affect gingival condition (e.g. calcium channel blockers, or aspirin therapy).
• Have current active caries or periodontitis that may, in the opinion of the investigator, compromise the study or the oral health of the subjects if they participate in the study.
• Restorations in a poor state of repair.
• Partial dentures or orthodontic appliances.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Las Vegas, Nevada, 89146, United States

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Tin Fluorides; fluorophosphate

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Tin 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: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: April 26, 2016
• Study Start: November 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 4, 2016
• Last Updated: October 26, 2017
• Results First Posted: November 11, 2016

Record last verified: 2016-09

Locations

US (1)