Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity

NCT ID: NCT02773758

Last Updated: 2017-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2016-03-11

Brief Summary

This will be a single centre, two week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participant with at least two sensitive teeth that meet the study criteria at the Screening and Baseline visits. The study will be conducted in participants in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening.

Conditions

Dentin Sensitivity

Study Design

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

Study Groups

Stannous Fluoride Dentifrice

Participants will be instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants will be permitted to rinse with tap water.

Group Type: EXPERIMENTAL

Stannous Fluoride Dentifrice

Intervention Type: OTHER

Experimental dentifrice containing 0.454%w/w stannous fluoride (1100ppm fluoride)

Sodium monofluorophosphate Dentifrice

Participants will be instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants will be permitted to rinse with tap water.

Group Type: OTHER

Sodium monofluorophosphate Dentifrice

Intervention Type: OTHER

Dentifrice containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride)

Interventions

Stannous Fluoride Dentifrice

Experimental dentifrice containing 0.454%w/w stannous fluoride (1100ppm fluoride)

Intervention Type: OTHER

Sodium monofluorophosphate Dentifrice

Dentifrice containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 18-65 years inclusive.
• Good general and mental health with:

No clinically significant and relevant abnormalities of medical history or 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.

• Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.
• Minimum of 20 natural teeth.
• Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria at screening: Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).

Tooth with MGI score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1.

Tooth with signs of sensitivity measured by qualifying evaporative air assessment (yes[Y]/No[N] response).

• Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria at screening:

Tooth with signs of sensitivity, measured by response to a qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2).

Exclusion Criteria

• Women who are breast-feeding, known to be pregnant or who are intending to become pregnant over the duration of the study.
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Previous participation in this study or participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
• Recent history (within the last year) of alcohol or other substance abuse.
• Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes or causing xerostomia.
• Dental prophylaxis within 4 weeks of Screening.
• Tongue or lip piercing or presence of dental implants.
• Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.
• Teeth bleaching within 8 weeks of Screening.
• Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening.
• Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine.
• Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice.
• Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening.
• Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.

Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs.

• Currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline.
• Daily dose of a medication which, in the opinion of the Investigator, is causing xerostomia.

• 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

Mississauga, Ontario, Canada

Countries

Canada

Other Identifiers

205201

Identifier Type: -

Identifier Source: org_study_id