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

NCT ID: NCT01494649

Last Updated: 2013-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-09-30

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

Study Design

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

Study Groups

Toothpaste containing 0.454% stannous fluoride

USA marketed toothpaste \[test\]

Group Type: ACTIVE_COMPARATOR

Test Toothpaste

Intervention Type: DRUG

0.454% stannous fluoride toothpaste

Toothpaste containing 0.76% sodium monofluorophosphate

USA marketed toothpaste \[negative control\]

Group Type: OTHER

Negative Control Toothpaste

Intervention Type: DRUG

0.76% sodium monofluorophosphate toothpaste

Interventions

Test Toothpaste

0.454% stannous fluoride toothpaste

Intervention Type: DRUG

Negative Control Toothpaste

0.76% sodium monofluorophosphate toothpaste

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion:

• 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.

• 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

BioSci Research America, Inc.

Las Vegas, Nevada, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27093773 (View on PubMed)

Other Identifiers

Z7871335

Identifier Type: -

Identifier Source: org_study_id