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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Summary:
Sponsor: GlaxoSmithKline

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

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

Current Secondary Outcome:

• 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:

• 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.

Dates:
Date Received: May 12, 2016
Date Started: January 2016
Date Completion:
Last Updated: October 17, 2016
Last Verified: May 2016