Clinical Trial: A Study to Investigate Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Pain Derived From Exposed Dentine in Response to Chemical, Thermal, Tactile, or Osmotic Stimuli.

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

Official Title: A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity

Brief Summary: This will be a single center, eight week, randomized, double blind, three treatment arm, parallel design, stratified (by mean baseline Schiff Sensitivity Score of the two selected test teeth) study in healthy participants.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo) [ Time Frame: Baseline and Week 8 ]

Original Primary Outcome: Change from baseline in Schiff Sensitivity Score of experimental dentifrice vs. placebo dentifrice at 8 weeks [ Time Frame: week 8 ]

Current Secondary Outcome:

• Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2) [ Time Frame: Baseline and Week 8 ]
  Schiff sensitivity score was assessed by 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.
• Change From Baseline in Schiff Sensitivity Score at Week 4 [ Time Frame: Baseline and Week 4 ]
  Schiff sensitivity score was assessed as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, using 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 syimulus; 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 Week 4 and 8 [ Time Frame: Baseline, Week 4 and 8 ]
  Pressure was administered using a constant pressure probe (Yeaple Probe). The constant pressure probe allows the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant reporting 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 greater the tactile threshold, the less sensitive the tooth.
• Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8 [ Time Frame: Baseline, Week 4 and 8 ]
  Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The subjects were asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain").

Original Secondary Outcome:

• Change from baseline in Schiff Sensitivity Score of two experimental dentifrices at 8 weeks [ Time Frame: week 8 ]
  Schiff sensitivity score will be assessed as subject's response to an evaporative (air) stimulus after the stimulation of each individual tooth, using scale range of 0-3; 0=Subject does not respond to air stimulation;1=Subject responds to air stimulus but does not request; 2=Subject responds to air stimulus and requests discontinuation or moves from stimulus; 3= Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
• Change from baseline in Schiff Sensitivity Score at 4 weeks [ Time Frame: week 4 ]
  Schiff sensitivity score will be assessed as subject's response to an evaporative (air) stimulus after the stimulation of each individual tooth, using scale range of 0-3; 0=Subject does not respond to air stimulation;1=Subject responds to air stimulus but does not request; 2=Subject responds to air stimulus and requests discontinuation or moves from stimulus; 3= Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
• Change from baseline in Tactile Threshold at 4 and 8 weeks [ Time Frame: week 4 and 8 ]
  A tactile threshold will be administered using a constant pressure probe (Yeaple Probe). The constant pressure probe allows the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied without the subject reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth.
• Change from baseline in visual rating scale (VRS) at 4 and 8weeks [ Time Frame: week 4 and 8 ]
  VRS will be assessed with as subject's intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The subjects will be asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain").

Dates:
Date Received: January 7, 2016
Date Started: January 2016
Date Completion:
Last Updated: January 16, 2017
Last Verified: January 2017