The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity

NCT ID: NCT02612064

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 488 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2016-06-03

Brief Summary

This single centre, dual site, comparative design study will be used to investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term use

Conditions

Dentin Sensitivity

Study Design

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

Study Groups

Stannous Fluoride dentifice

Participants will apply (under supervision) a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100ppm) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing will be permitted

Group Type: EXPERIMENTAL

Stannous Fluoride dentifice

Intervention Type: DEVICE

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

Sodium Monofluorophosphate dentifrice

Participants will apply (under supervision) a pea-sized dose of dentifrice containing Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing will be permitted.

Group Type: OTHER

Sodium Monofluorophosphate dentifrice

Intervention Type: OTHER

Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)

Interventions

Stannous Fluoride dentifice

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

Intervention Type: DEVICE

Sodium Monofluorophosphate dentifrice

Dentifrice containing 0.76% 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
• Good general and mental health with, in the opinion of the investigator or medically qualified designee:

A. No clinically significant and relevant abnormalities in medical history or upon oral examination.

B. 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.

• Dental health

At Screening:

A. Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.

B. Good general oral health, with a minimum of 20 natural teeth.

C. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria:

• Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).
• Tooth with modified gingival index (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 (Y/N response).

At Baseline:

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

• Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff Sensitivity Score ≥ 2)

Exclusion Criteria

• Pregnant or breast feeding women
• Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.
• Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.
• Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia. - Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
• Any condition which, in the opinion of the investigator, causes xerostomia.
• 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.
• Recent history (within the last year) of alcohol or other substance abuse
• Dental prophylaxis within four weeks of Screening.
• Tongue or lip piercing or presence of dental implants.
• Desensitizing treatment within eight weeks of Screening (professional sensitivity treatments and non-toothpaste sensitivity treatments).
• 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 eight 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 toothpaste in the opinion of the investigator.
• Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening
• Individuals who require antibiotic prophylaxis for dental procedures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 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

Ellesmere Port, Cheshire, United Kingdom

GSK Investigational Site

Metropolitan Borough of Wirral, , United Kingdom

Countries

United Kingdom

Other Identifiers

205072

Identifier Type: -

Identifier Source: org_study_id