Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity

• ClinicalTrials.gov Identifier: NCT02773758
• Recruitment Status: Completed
• First Posted: May 16, 2016
• Results First Posted: December 12, 2016
• Last Update Posted: September 29, 2017
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Tracking Information

• First Submitted Date: May 12, 2016
• First Posted Date: May 16, 2016
• Results First Submitted Date: October 17, 2016
• Results First Posted Date: December 12, 2016
• Last Update Posted Date: September 29, 2017
• Actual Study Start Date: January 1, 2016
• Actual Primary Completion Date: March 11, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 17, 2016)

Change From Baseline in Schiff Sensitivity Score at Day 14 [ Time Frame: Baseline, Day 14 ]

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.

Original Primary Outcome Measures (submitted: May 12, 2016)

Change From Baseline in Schiff Sensitivity Score following fourteen days of treatment [ Time Frame: Baseline to 14 days ]

Schiff Sensitivity Score is an examiner based index, will be 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 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.

Current Secondary Outcome Measures (submitted: October 17, 2016)

• Change From Baseline in Schiff Sensitivity Score at Day 7 [ Time Frame: Baseline, Day 7 ]
  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.
• Change From Baseline in Tactile Threshold at Day 7 and Day 14 [ Time Frame: Baseline, Day 7 and Day 14 ]
  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.

Original Secondary Outcome Measures (submitted: May 12, 2016)

• Change From Baseline in Schiff Sensitivity Score Following Seven Days Of Treatment [ Time Frame: Baseline to 7 days ]
  Schiff Sensitivity Score is an examiner based index, will be 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 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.
• Change From Baseline in Tactile Threshold Following Seven and fourteen Days of Treatment [ Time Frame: Baseline to 7 days and 14 days ]
  A tactile stimulus will be administered using a constant pressure probe (Yeaple Probe). Response to this stimulus will be evaluated as tactile threshold. The constant pressure probe allows 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity
• Official Title: Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
• Brief Summary: This will be a single centre, two week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participant with at least two sensitive teeth that meet the study criteria at the Screening and Baseline visits. The study will be conducted in participants in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Dentin Sensitivity

Intervention

• Other: Stannous Fluoride Dentifrice
  Experimental dentifrice containing 0.454%w/w stannous fluoride (1100ppm fluoride)
• Other: Sodium monofluorophosphate Dentifrice
  Dentifrice containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride)

Study Arms

• Experimental: Stannous Fluoride Dentifrice
  Participants will be instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants will be permitted to rinse with tap water.
  Intervention: Other: Stannous Fluoride Dentifrice
• Sodium monofluorophosphate Dentifrice
  Participants will be instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants will be permitted to rinse with tap water.
  Intervention: Other: Sodium monofluorophosphate Dentifrice

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 10, 2017): 143
• Original Actual Enrollment (submitted: May 12, 2016): 149
• Actual Study Completion Date: March 11, 2016
• Actual Primary Completion Date: March 11, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.
• Good general and mental health with:

No clinically significant and relevant abnormalities of medical history or oral examination.

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 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 at screening: 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 ≤1.

Tooth with signs of sensitivity measured by qualifying evaporative air assessment (yes[Y]/No[N] response).

• Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria at screening:

Tooth with signs of sensitivity, measured by response to a qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2).

Exclusion Criteria:

• Women who are breast-feeding, known to be pregnant or who are intending to become pregnant over the duration of the study.
• 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.
• Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes or causing 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.
• 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.
• 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, tranquilisers, 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02773758
• Other Study ID Numbers: 205201
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: GlaxoSmithKline
• Study Sponsor: GlaxoSmithKline
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: August 2017