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

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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:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dentin Sensitivity
Interventions Other: Stannous Fluoride Dentifrice
Other: Sodium monofluorophosphate Dentifrice
Enrollment 143
Recruitment Details Participants were recruited at a single center in Canada.
Pre-assignment Details A total of 143 participants were enrolled in the study. Out of which 141 participants were randomized.
Arm/Group Title Stannous Fluoride Dentifrice Sodium Monofluorophosphate Dentifrice
Hide Arm/Group Description Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride), 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 were permitted to rinse with tap water. Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
Period Title: Overall Study
Started 71 70
Completed 71 70
Not Completed 0 0
Arm/Group Title Stannous Fluoride Dentifrice Sodium Monofluorophosphate Dentifrice Total
Hide Arm/Group Description Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride), 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 were permitted to rinse with tap water. Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water. Total of all reporting groups
Overall Number of Baseline Participants 72 69 141
Hide Baseline Analysis Population Description
One participant was randomized to sodium monofluorophosphate dentifrice but received stannous fluoride dentifrice, therefore, treatment arm "stannous fluoride dentifrice" included 72 participants & treatment arm "sodium monofluorophosphate dentifrice" included 69 participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 69 participants 141 participants
47.7  (10.27) 48.0  (10.58) 47.9  (10.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 69 participants 141 participants
Female
55
  76.4%
50
  72.5%
105
  74.5%
Male
17
  23.6%
19
  27.5%
36
  25.5%
1.Primary Outcome
Title Change From Baseline in Schiff Sensitivity Score at Day 14
Hide Description 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.
Time Frame Baseline, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on Intent-to-treat (ITT) population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.
Arm/Group Title Stannous Fluoride Dentifrice Sodium Monofluorophosphate Dentifrice
Hide Arm/Group Description:
Participants were instructed to 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 were permitted to rinse with tap water.
Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: score on a scale
At Baseline 2.70  (0.427) 2.74  (0.423)
Change From Baseline at Day 14 -1.38  (0.843) -0.10  (0.405)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stannous Fluoride Dentifrice, Sodium Monofluorophosphate Dentifrice
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.
Method of Estimation Estimation Parameter Least square (LS) mean difference
Estimated Value -1.29
Confidence Interval (2-Sided) 95%
-1.509 to -1.071
Estimation Comments Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.
2.Secondary Outcome
Title Change From Baseline in Schiff Sensitivity Score at Day 7
Hide Description 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.
Time Frame Baseline, Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.
Arm/Group Title Stannous Fluoride Dentifrice Sodium Monofluorophosphate Dentifrice
Hide Arm/Group Description:
Participants were instructed to 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 were permitted to rinse with tap water.
Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: score on a scale
At Baseline 2.70  (0.427) 2.74  (0.423)
Change from baseline at Week 7 -0.74  (0.446) -0.04  (0.374)
3.Secondary Outcome
Title Change From Baseline in Tactile Threshold at Day 7 and Day 14
Hide Description 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.
Time Frame Baseline, Day 7 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.
Arm/Group Title Stannous Fluoride Dentifrice Sodium Monofluorophosphate Dentifrice
Hide Arm/Group Description:
Participants were instructed to 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 were permitted to rinse with tap water.
Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: gram (g)
At Baseline 11.83  (3.189) 11.50  (2.992)
Change from Baseline at Day 7 5.92  (6.113) 0.86  (3.898)
Change from Baseline at Day 14 15.21  (11.663) 0.86  (3.708)
Time Frame From start of screening to 5 days following last administration of the study product (up to 39 days)
Adverse Event Reporting Description Safety population included 72 participants in treatment arm "stannous fluoride dentifrice" & 69 participants in treatment arm "sodium monofluorophosphate dentifrice".
 
Arm/Group Title Stannous Fluoride Dentifrice Sodium Monofluorophosphate Dentifrice
Hide Arm/Group Description Participants were 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 were permitted to rinse with tap water. Participants were 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 were permitted to rinse with tap water.
All-Cause Mortality
Stannous Fluoride Dentifrice Sodium Monofluorophosphate Dentifrice
Affected / at Risk (%) Affected / at Risk (%)
Total   0/72 (0.00%)   0/69 (0.00%) 
Hide Serious Adverse Events
Stannous Fluoride Dentifrice Sodium Monofluorophosphate Dentifrice
Affected / at Risk (%) Affected / at Risk (%)
Total   0/72 (0.00%)   0/69 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Stannous Fluoride Dentifrice Sodium Monofluorophosphate Dentifrice
Affected / at Risk (%) Affected / at Risk (%)
Total   3/72 (4.17%)   0/69 (0.00%) 
General disorders     
Pyrexia  1/72 (1.39%)  0/69 (0.00%) 
Infections and infestations     
Influenza  1/72 (1.39%)  0/69 (0.00%) 
Nervous system disorders     
Headache  1/72 (1.39%)  0/69 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02773758    
Other Study ID Numbers: 205201
First Submitted: May 12, 2016
First Posted: May 16, 2016
Results First Submitted: October 17, 2016
Results First Posted: December 12, 2016
Last Update Posted: September 29, 2017