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: NCT02832375
• Other study ID #: 205697
• Status: Completed
• Phase: Phase 3
• First received: March 28, 2016
• Last updated: January 5, 2017
• Start date: March 2016
• Est. completion date: May 2016

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This single center, 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 center, three day, randomized, 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. DH will be assessed at baseline (pre-treatment), post-treatment and after 3 days twice daily brushing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Demonstrates understanding of the study 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: No clinically significant, relevant abnormalities of medical history or oral examination and 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

• Self-reported history of DH lasting more than six months but not more than 10 years at screening

• Minimum of 20 natural teeth at screening

• 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 and a clinical mobility of less than or equal to (=)1 and Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y[Yes]/N[No] response) screening

• Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars),that meet all of the following criteria at Baseline: 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. Females of child bearing potential who have a positive urine pregnancy test or who are breast feeding

• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients

• Previous participation in this study or 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

• 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, 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

• 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, tranquilizers, anti-depressants, mood-altering and anti-inflammatory drugs.

• Currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline, Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Intervention

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

Locations

Country	Name	City	State
United States	GSK Investigational Site	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Schiff Sensitivity Score on Day 3	Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.	Baseline, Day 3	No
Secondary	Change From Baseline in Schiff Sensitivity Score after single use	Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.	Baseline, after single use (after 5 minutes)	No
Secondary	Change From Baseline in Tactile Threshold Immediately after Single Use and on Day 3	Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.	Baseline, after single use (after 5 minutes) and on Day 3	No