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

NCT02612064 | Completed Results

• 1 other identifier: 205072
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Schiff Sensitivity Score on Day 3

  The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.

  Baseline to 3 days

Secondary Outcomes (2)

• Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application

  Baseline to 60 seconds post first treatment

• Change From Baseline in Tactile Threshold Post First Treatment by Direct Application and on Day 3

  Baseline, 60 seconds post first treatment, Day 3

Study Arms (2)

Stannous Fluoride dentifice

EXPERIMENTAL

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

Device: Stannous Fluoride dentifice

Sodium Monofluorophosphate dentifrice

OTHER

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.

Other: Sodium Monofluorophosphate dentifrice

Interventions

Stannous Fluoride dentifice DEVICE

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

Stannous Fluoride dentifice

Sodium Monofluorophosphate dentifrice OTHER

Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)

Sodium Monofluorophosphate dentifrice

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Ellesmere Port, Cheshire, CH65 4BW, United Kingdom

Location

GSK Investigational Site

Metropolitan Borough of Wirral, CH41 6EY, United Kingdom

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

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 19, 2015
• First Posted: November 23, 2015
• Study Start: November 1, 2015
• Primary Completion: June 3, 2016
• Study Completion: June 3, 2016
• Last Updated: May 17, 2017
• Results First Posted: March 23, 2017

Record last verified: 2017-04

Locations

GB (2)