Back to resultsClinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity
Primary Purpose
Dentin Sensitivity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Potassium nitrate and sodium fluoride
Standard fluoride dentifrice
Sponsored by
About this trial
This is an interventional treatment trial for Dentin Sensitivity
Eligibility Criteria
Inclusion Criteria:
- Participants in good general health, with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
- Participants with minimum of 20 natural teeth.
At screening, a minimum of four, non-adjacent teeth.
- Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
- Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1.
- Teeth that are determined to be sensitive by the participant following a 1 second air blast to the cervical margin.
Exclusion Criteria:
- Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
- Any condition which, in the opinion of the investigator, causes dry mouth.
- Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
- In the 8 weeks prior to screening use of an oral care product indicated for the relief of DH.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Potassium nitrate and sodium fluoride
Standard fluoride dentifrice
Arm Description
3.0% weight by weight (w/w) potassium nitrate mouthwash with 0.02% sodium fluoride
Standard fluoride dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate (SMFP)
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Schiff Sensitivity Score at Week 8
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.
Secondary Outcome Measures
Mean Change From Baseline in Schiff Sensitivity Score at Week 4
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.
Mean Change From Baseline in Tactile Threshold at Week 8
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.
Mean Change From Baseline in Tactile Threshold at Week 4
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.
Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8
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.
Mean Change From Baseline in VRS at Week 4
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02226562
Brief Title
Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity
Official Title
A Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 2, 2014 (undefined)
Primary Completion Date
December 1, 2014 (Actual)
Study Completion Date
December 5, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth) study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
191 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Potassium nitrate and sodium fluoride
Arm Type
Experimental
Arm Description
3.0% weight by weight (w/w) potassium nitrate mouthwash with 0.02% sodium fluoride
Arm Title
Standard fluoride dentifrice
Arm Type
Other
Arm Description
Standard fluoride dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate (SMFP)
Intervention Type
Drug
Intervention Name(s)
Potassium nitrate and sodium fluoride
Intervention Description
3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride
Intervention Type
Drug
Intervention Name(s)
Standard fluoride dentifrice
Intervention Description
Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Schiff Sensitivity Score at Week 8
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
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Schiff Sensitivity Score at Week 4
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
Title
Mean Change From Baseline in Tactile Threshold at Week 8
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
Title
Mean Change From Baseline in Tactile Threshold at Week 4
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
Title
Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8
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
Title
Mean Change From Baseline in VRS at Week 4
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants in good general health, with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
Participants with minimum of 20 natural teeth.
At screening, a minimum of four, non-adjacent teeth.
Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1.
Teeth that are determined to be sensitive by the participant following a 1 second air blast to the cervical margin.
Exclusion Criteria:
Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
Any condition which, in the opinion of the investigator, causes dry mouth.
Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
In the 8 weeks prior to screening use of an oral care product indicated for the relief of DH.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30803493
Citation
Hall C, Sufi F, Milleman JL, Milleman KR. Efficacy of a 3% potassium nitrate mouthrinse for the relief of dentinal hypersensitivity: An 8-week randomized controlled study. J Am Dent Assoc. 2019 Mar;150(3):204-212. doi: 10.1016/j.adaj.2018.10.023.
Results Reference
derived
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Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity
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