Pilot Study to Investigate the Efficacy of a Toothpaste in Providing Relief From Dentinal Hypersensitivity

NCT01494649 | Completed Results

• 1 other identifier: Z7871335
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

A pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine Hypersensitivity compared to a control toothpaste.

Conditions

Dentinal Sensitivity; Hypersensitivity

Keywords

dentinal; hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment

  Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline.

  Baseline and immediately after treatment administration

Secondary Outcomes (5)

• Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3

  Baseline and Day 3

• Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14

  Baseline and Day 14

• Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment

  Baseline and immediately after treatment administration

• Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3

  Baseline and Day 3

• Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14

  Baseline and Day 14

Study Arms (2)

Toothpaste containing 0.454% stannous fluoride

ACTIVE COMPARATOR

USA marketed toothpaste \[test\]

Drug: Test Toothpaste

Toothpaste containing 0.76% sodium monofluorophosphate

OTHER

USA marketed toothpaste \[negative control\]

Drug: Negative Control Toothpaste

Interventions

Test Toothpaste DRUG

0.454% stannous fluoride toothpaste

Toothpaste containing 0.454% stannous fluoride

Negative Control Toothpaste DRUG

0.76% sodium monofluorophosphate toothpaste

Toothpaste containing 0.76% 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:

• Self-reported history of dentinal hypersensitivity lasting more than 6 months and less than 10 years
• Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
• Teeth having a gingival index score of less than or equal to 1
• Teeth with a clinical mobility less than or equal to 1
• sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity as measured by tactile stimulus (Yeaple probe, tactile threshold 10g) and evaporative (air) stimulus (Schiff Sensitivity Score ≥ 2).

You may not qualify if:

• Presence of chronic debilitating disease which could affect study outcomes.
• Any condition which 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, or not expected to respond to treatment with an over-the counter dentifrice.
• Daily doses of a medication which could interfere with the perception of pain.
• Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.
• Individuals who require antibiotic prophylaxis for dental procedures.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

BioSci Research America, Inc.

Las Vegas, Nevada, 89121, United States

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

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: December 19, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 8, 2013
• Results First Posted: May 8, 2013

Record last verified: 2012-08

Locations

US (1)