The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity

NCT03072719 | Completed Phase 3 Results

• 2 other identifiers: 202161RH01327
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site study in subjects with at least two sensitive teeth to compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity.

Conditions

Dentine Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Schiff Sensitivity Score on Day 14

  Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.

  Baseline, Day 14

Secondary Outcomes (2)

• Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3

  Baseline, post first brushing (after 5 minutes) and Day 3

• Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14

  Baseline, post first brushing (after 5 minutes), Day 3 and Day 14

Study Arms (2)

Dentifrice containing stannous fluoride

EXPERIMENTAL

Toothpaste

Drug: Stannous Fluoride

Dentifrice containing Sodium Monofluorophosphate

ACTIVE COMPARATOR

Toothpaste

Drug: Sodium Monofluorophosphate

Interventions

Stannous Fluoride DRUG

Test dentifrice, participants will brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute.

Dentifrice containing stannous fluoride

Sodium Monofluorophosphate DRUG

Control dentifrice, participants will brush the whole mouth thoroughly for at least 1 minute.

Dentifrice containing Sodium Monofluorophosphate

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 and willingness to participate
• Aged at least 18 to 65 years
• Understands and is willing, able and likely to comply with all study procedures and restrictions
• Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination.
• Self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years
• Minimum of 20 natural teeth at screening, a minimum of two accessible teeth (incisors, canines, pre-molars)
• At baseline, participant has two non-adjacent sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity measured by tactile stimulus (Yeaple ≤ 20g) and evaporative (air) assessment (Schiff Sensitivity Score ≥ 2) at baseline

You may not qualify if:

• Pregnant or breast-feeding women
• 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 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
• An employee of the sponsor or the study site or members of their immediate family
• 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
• Dental prophylaxis within 4 weeks of screening
• Tongue or lip piercing or presence of dental implants
• Professional desensitising treatment within 12 weeks of screening
• 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 12 weeks of screening
• Tooth with evidence of current or recent caries, or reported treatment of decay in 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 in the opinion of the investigator.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Cork, Ireland

Location

Related Publications (1)

• Parkinson CR, Hughes N, Hall C, Whelton H, Gallob J, Mason S. Three randomized clinical trials to assess the short-term efficacy of anhydrous 0.454% w/w stannous fluoride dentifrices for the relief of dentin hypersensitivity. Am J Dent. 2016 Feb;29(1):25-32.

  PMID: 27093773 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Tin Fluorides; fluorophosphate

Condition Hierarchy (Ancestors)

Tooth 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: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 7, 2017
• Study Start: March 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 12, 2012
• Last Updated: March 6, 2018
• Results First Posted: April 18, 2017

Record last verified: 2018-02

Locations

IE (1)