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Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity

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ClinicalTrials.gov Identifier: NCT02226562
Recruitment Status : Completed
First Posted : August 27, 2014
Results First Posted : August 26, 2015
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Dentin Sensitivity
Interventions Drug: Potassium nitrate and sodium fluoride
Drug: Standard fluoride dentifrice
Enrollment 191
Recruitment Details The participants were recruited at a clinical site in the USA
Pre-assignment Details  
Arm/Group Title Dentifrice Plus Oral Rinse Dentifrice Alone
Hide Arm/Group Description 3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
Period Title: Overall Study
Started 95 96
Completed 95 95 [1]
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
[1]
Lost to follow up
Arm/Group Title Dentifrice Plus Oral Rinse Dentifrice Alone Total
Hide Arm/Group Description 3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP) Total of all reporting groups
Overall Number of Baseline Participants 95 96 191
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 95 participants 96 participants 191 participants
41.7  (8.62) 39.7  (8.14) 40.7  (8.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 96 participants 191 participants
Female
81
  85.3%
79
  82.3%
160
  83.8%
Male
14
  14.7%
17
  17.7%
31
  16.2%
1.Primary Outcome
Title Mean Change From Baseline in Schiff Sensitivity Score at Week 8
Hide Description The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 is indicative of an imrpovement in sensitivity.
Time Frame Baseline to 8 week
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
Arm/Group Title Dentifrice Plus Oral Rinse Dentifrice Alone
Hide Arm/Group Description:
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
Overall Number of Participants Analyzed 95 95
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
-1.47  (0.065) -0.37  (0.065)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dentifrice Plus Oral Rinse, Dentifrice Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments The P-value was less than 0.0001
Method ANCOVA
Comments ANCOVA with a factor for treatment and baseline as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.10
Confidence Interval (2-Sided) 95%
-1.28 to -0.92
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline in Schiff Sensitivity Score at Week 4
Hide Description The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 is indicative of an imrpovement in sensitivity.
Time Frame Baseline to 4 week
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
Arm/Group Title Dentifrice Plus Oral Rinse Dentifrice Alone
Hide Arm/Group Description:
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
Overall Number of Participants Analyzed 95 95
Mean (Standard Deviation)
Unit of Measure: Scores on scale
-0.94  (0.719) -0.31  (0.542)
3.Secondary Outcome
Title Mean Change From Baseline in Tactile Threshold at Week 8
Hide Description The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Time Frame Baseline to 8 week
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
Arm/Group Title Dentifrice Plus Oral Rinse Dentifrice Alone
Hide Arm/Group Description:
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
Overall Number of Participants Analyzed 95 95
Mean (Standard Deviation)
Unit of Measure: Gram(g)
31.32  (27.869) 3.74  (13.188)
4.Secondary Outcome
Title Mean Change From Baseline in Tactile Threshold at Week 4
Hide Description The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Time Frame Baseline to 4 week
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
Arm/Group Title Dentifrice Plus Oral Rinse Dentifrice Alone
Hide Arm/Group Description:
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
Overall Number of Participants Analyzed 95 95
Mean (Standard Deviation)
Unit of Measure: Gram (g)
14.11  (21.276) 0.74  (4.434)
5.Secondary Outcome
Title Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8
Hide Description Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.
Time Frame Baseline to 8 week
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
Arm/Group Title Dentifrice Plus Oral Rinse Dentifrice Alone
Hide Arm/Group Description:
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
Overall Number of Participants Analyzed 95 95
Mean (Standard Deviation)
Unit of Measure: Score on scale
-3.05  (2.038) -1.05  (1.673)
6.Secondary Outcome
Title Mean Change From Baseline in VRS at Week 4
Hide Description Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.
Time Frame Baseline to 4 week
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
Arm/Group Title Dentifrice Plus Oral Rinse Dentifrice Alone
Hide Arm/Group Description:
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
Overall Number of Participants Analyzed 95 95
Mean (Standard Deviation)
Unit of Measure: Score on scale
-1.64  (1.651) -0.86  (1.295)
Time Frame Upto 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dentifrice Plus Oral Rinse Dentifrice Alone
Hide Arm/Group Description 3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
All-Cause Mortality
Dentifrice Plus Oral Rinse Dentifrice Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dentifrice Plus Oral Rinse Dentifrice Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/95 (0.00%)      0/96 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Dentifrice Plus Oral Rinse Dentifrice Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/95 (11.58%)      7/96 (7.29%)    
Gastrointestinal disorders     
Sensitivity of teeth   2/95 (2.11%)  2 2/96 (2.08%)  2
Dry mouth   0/95 (0.00%)  0 1/96 (1.04%)  1
Mouth ulceration   0/95 (0.00%)  0 1/96 (1.04%)  1
Tooth impacted   1/95 (1.05%)  1 0/96 (0.00%)  0
General disorders     
Device failure   0/95 (0.00%)  0 1/96 (1.04%)  1
Infections and infestations     
Vulvovaginal mycotic infection   2/95 (2.11%)  2 0/96 (0.00%)  0
Pharyngitis   0/95 (0.00%)  0 1/96 (1.04%)  1
Pharyngitis streptococcal   0/95 (0.00%)  0 1/96 (1.04%)  1
Sinusitis   1/95 (1.05%)  1 0/96 (0.00%)  0
Urinary tract infection   1/95 (1.05%)  1 0/96 (0.00%)  0
Injury, poisoning and procedural complications     
Traumatic ulcer   1/95 (1.05%)  1 1/96 (1.04%)  1
Epicondylitis   1/95 (1.05%)  1 0/96 (0.00%)  0
Mouth injury   1/95 (1.05%)  1 0/96 (0.00%)  0
Thermal burn   1/95 (1.05%)  1 0/96 (0.00%)  0
Metabolism and nutrition disorders     
Hypercholesterolemia   1/95 (1.05%)  1 0/96 (0.00%)  0
Nervous system disorders     
Headache   1/95 (1.05%)  1 0/96 (0.00%)  0
Migraine   1/95 (1.05%)  1 0/96 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis contact   1/95 (1.05%)  1 0/96 (0.00%)  0
Indicates events were collected by systematic assessment
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02226562     History of Changes
Other Study ID Numbers: 202196
RH02492 ( Other Identifier: GSK )
First Submitted: August 25, 2014
First Posted: August 27, 2014
Results First Submitted: July 30, 2015
Results First Posted: August 26, 2015
Last Update Posted: August 27, 2018