To Investigate the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population

NCT02937636 | Completed Results

• 1 other identifier: 207014
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This single-centre, examiner-blind, randomized, stratified, two-treatment, parallel group clinical study will evaluate the efficacy of a 0.454% w/w stannous fluoride dentifrice compared to a reference dentifrice to control gingivitis (gingival bleeding and visual signs of gingival inflammation) in dentally and periodontally healthy adult volunteers over 12 weeks use in a Chinese population.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• Mean Bleeding Index (BI)

  The BI was performed by a single examiner using a color coded periodontal probe. The probe was inserted approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. This measure will be analyzed and summarized over all sites.

  At Week 12

Secondary Outcomes (3)

• Number of Bleeding Sites

  At Week 12

• Mean Modified Gingival Index (MGI)

  At Week 12

• Mean Plaque Index (PI) (Overall and Interproximal)

  At Week 12

Study Arms (2)

Test Product

EXPERIMENTAL

Participants will apply a full strip of dentifrice to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine.

Other: Stannous fluoride

Reference Product

ACTIVE COMPARATOR

Participants will apply a full strip of dentifrice to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine.

Other: Sodium monofluorophosphate

Interventions

Stannous fluoride OTHER

Experimental dentifrice containing 0.454% w/w stannous fluoride \& 0.0721% w/w sodium fluoride containing1450 parts per million (ppm) fluoride

Test Product

Sodium monofluorophosphate OTHER

Dentifrice containing 0.14% w/w sodium monofluorophosphate containing1400 ppm fluoride

Reference Product

Eligibility Criteria

• Age: 18 Years - 65 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.
• Aged 18 to 65 years.
• Understands and is willing, able and likely to comply with all study procedures and restrictions.
• Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon oral examination, absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
• A minimum of 20 natural teeth (all teeth; incisors, canines, pre-molars \& molars), and a minimum of 40 gradable surfaces for MGI, BI and PI. A scorable surface is defined as a surface that has 50% of the surface gradable for each clinical index. Third molars, orthodontically banded/bonded, fully crowned or extensively restored or grossly carious teeth are not included in the tooth count, moderate gingivitis present at the screening visit (in the opinion of the clinical examiner from a gross visual examination) and mean whole mouth MGI between 1.75 and 2.30 and a mean overall PI score \>1.5 at Baseline visit.

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.
• Screening: Currently taking antibiotics or requiring antibiotic use prior to dental prophylaxis or other dental procedures, currently taking an anti-inflammatory medication or traditional Chinese medicines (TCM) which, in the opinion of the Investigator, could affect gingival condition, currently taking a systemic medication which, in the opinion of the Investigator, could affect gingival condition (e.g. calcium channel blockers, or aspirin therapy).
• Baseline (Visit 2): Has taken, or currently taking, antibiotics in the previous 14 days, or an anti-inflammatory medication or a systemic medication days (e.g. calcium channel blockers, or aspirin therapy) which, in the opinion of the Investigator, could affect gingival condition in the previous 14 days.
• Have current active caries or periodontitis that may, in the opinion of the investigator, compromise the study or the oral health of the participants if they participate in the study, restorations in a poor state of repair, partial dentures or orthodontic appliances, teeth bleaching within 12 weeks of screening and use of a chlorhexidine mouthwash currently, or within 14 days of baseline.
• Participation in another clinical study or receipt of an investigational drug or investigational oral care product within 30 days of Baseline (Visit 2) and 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 and employed by any dentifrice manufacturer or their immediate family.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Shanghai, 200023, China

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

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  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: October 17, 2016
• First Posted: October 18, 2016
• Study Start: September 19, 2017
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: June 14, 2019
• Results First Posted: June 14, 2019

Record last verified: 2019-03

Locations

CN (1)