Short Term Clinical Study Investigating 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: NCT02731833
• Other study ID #: 205710
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2016
• Last updated: September 19, 2016
• Start date: April 2016
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This single centre, 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 compared with a standard fluoride dentifrice

Description:

This will be a single centre, three day, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participants with at least two sensitive teeth that meet all the criteria at the screening and baseline (pre-treatment) visits. Dentinal hypersensitivity will be assessed at baseline (pre-treatment), post-treatment and after 3 days twice daily brushing

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 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

• Aged 18-65 years inclusive

• Understands and is willing, able and likely to comply with all study procedures and restrictions

• Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities of medical history or oral examination. b) Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements

• Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years

• Minimum of 20 natural teeth

• 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 MGI score =0 adjacent to the test area (exposed dentine) only [Lobene, 1986] and a clinical mobility of =1, Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response)

• 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:

• Women who are known to be pregnant or who are intending to become pregnant over the duration of the study

• Women who are breast-feeding

• 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.

• Previous participation in this study

• 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 or Any condition which, in the opinion of the investigator, causes xerostomia

• Dental prophylaxis within 4 weeks of Screening or Tongue or lip piercing or presence of dental implants

• Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening and teeth bleaching within 8 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 dentifrice in the opinion of the investigator

• Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening (participants will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients)

• Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs

• Currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Intervention

Other:
• stannous fluoride
0.454% w/w stannous fluoride containing 1100ppm fluoride
• sodium monofluorophosphate
0.76% w/w sodium monofluorophosphate containing 1000ppm fluoride

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Schiff sensitivity score at Day 3	The examiner will indicate 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 3	No
Secondary	Change from baseline in tactile threshold at Day 3	The examiner will assess the response to tactile sensitivity using a Yeaple probe which allows the application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force is reached. The tactile threshold for each tooth is determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gives two consecutive 'yes' responses is recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used will be 20g; at all subsequent visits, it will be 80g	Baseline to Day 3	No
Secondary	Change from baseline in Schiff sensitivity score after a single use	The examiner will indicate 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 upto 5 minutes post treatment	No
Secondary	Change from baseline in tactile threshold after a single use	The examiner will assess the response to tactile sensitivity using a Yeaple probe which allows the application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force is reached. The tactile threshold for each tooth is determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gives two consecutive 'yes' responses is recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used will be 20g; at all subsequent visits, it will be 80g	Baseline upto 5 minutes post treatment	No