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

NCT ID: NCT03072719

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-01
• Study Completion Date: 2012-06-12

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

Study Design

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

Study Groups

Dentifrice containing stannous fluoride

Toothpaste

Group Type: EXPERIMENTAL

Stannous Fluoride

Intervention Type: 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 Sodium Monofluorophosphate

Toothpaste

Group Type: ACTIVE_COMPARATOR

Sodium Monofluorophosphate

Intervention Type: DRUG

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

Interventions

Stannous Fluoride

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.

Intervention Type: DRUG

Sodium Monofluorophosphate

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion

• 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.
• Use of a desensitising dentifrice within six weeks of screening (participant will be required to bring their current dentifrice to the site in order to verify the lack of known anti-sensitivity ingredients)
• Daily doses of a medication which, in the opinion of the investigator, could interfere with the perception of pain
• Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.
• Daily doses of a medication which, in the opinion of the investigator, causes xerostomia
• Individuals who require antibiotic prophylaxis for dental procedures
• Any participant who, in the judgment of the investigator, should not participate in the study.

• 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

GSK Investigational Site

Cork, , Ireland

Countries

Ireland

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

RH01327

Identifier Type: OTHER

Identifier Source: secondary_id

202161

Identifier Type: -

Identifier Source: org_study_id

NCT01724008

Identifier Type: -

Identifier Source: nct_alias