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

Dentin Sensitivity Clinical Trial

Official title:

A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612064
• Other study ID #: 205072
• Status: Completed
• Phase: N/A
• First received: November 19, 2015
• Last updated: January 16, 2017
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

• Sensitive tooth not expected to respond to treatment with an over-the-counter toothpaste in the opinion of the investigator.

• Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening

• Individuals who require antibiotic prophylaxis for dental procedures

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Intervention

Device:
• Stannous Fluoride dentifice
Experimental dentifrice containing 0.454% w/w stannous fluoride (1100ppm)

Other:
• Sodium Monofluorophosphate dentifrice
Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Ellesmere Port	Cheshire
United Kingdom	GSK Investigational Site	Wirral

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline (Day 0 pre-treatment) in Schiff sensitivity score to Day 3	Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 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.	Baseline to 3 days
Secondary	Change from baseline in Schiff sensitivity score to Day 0 post-treatment	Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 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.	Baseline to Day 0 post-treatment
Secondary	Changes from baseline (Day 0 pre-treatment) in tactile threshold (g) to Day 0 post-treatment and Day 3	A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth.	Baseline to (Day 0 pre-treatment) to Day 0 post-treatment and Day 3