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Trial record 5 of 32 for:    FLUORIDE ION AND NITRATE ION

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

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.

Condition or disease Intervention/treatment Phase
Dentin Sensitivity Drug: Potassium nitrate and sodium fluoride Drug: Standard fluoride dentifrice Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity
Study Start Date : September 2, 2014
Actual Primary Completion Date : December 1, 2014
Actual Study Completion Date : December 5, 2014


Arm Intervention/treatment
Experimental: Potassium nitrate and sodium fluoride
3.0% weight by weight (w/w) potassium nitrate mouthwash with 0.02% sodium fluoride
Drug: Potassium nitrate and sodium fluoride
3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride

Standard fluoride dentifrice
Standard fluoride dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate (SMFP)
Drug: Standard fluoride dentifrice
Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP




Primary Outcome Measures :
  1. Mean Change From Baseline in Schiff Sensitivity Score at Week 8 [ Time Frame: Baseline to 8 week ]
    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 :
  1. Mean Change From Baseline in Schiff Sensitivity Score at Week 4 [ Time Frame: Baseline to 4 week ]
    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.

  2. Mean Change From Baseline in Tactile Threshold at Week 8 [ Time Frame: Baseline to 8 week ]
    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.

  3. Mean Change From Baseline in Tactile Threshold at Week 4 [ Time Frame: Baseline to 4 week ]
    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.

  4. Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8 [ Time Frame: Baseline to 8 week ]
    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.

  5. Mean Change From Baseline in VRS at Week 4 [ Time Frame: Baseline to 4 week ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

    1. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
    2. Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1.
    3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226562


Locations
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United States, Indiana
GSK Investigational Site
Fort Wayne, Indiana, United States, 46825
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02226562     History of Changes
Other Study ID Numbers: 202196
RH02492 ( Other Identifier: GSK )
First Posted: August 27, 2014    Key Record Dates
Results First Posted: August 26, 2015
Last Update Posted: August 27, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Fluorides
Sodium Fluoride
Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents