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

• 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: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Indiana

GSK Investigational Site

Fort Wayne, Indiana, United States, 46825

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02226562
• Other Study ID Numbers: 202196; RH02492 ( Other Identifier: GSK )
• First Posted: August 27, 2014
• Results First Posted: August 26, 2015
• Last Update Posted: August 27, 2018
• Last Verified: July 2018

Additional relevant MeSH terms:

Dentin Sensitivity; Hypersensitivity; Immune System Diseases; Tooth Diseases; Stomatognathic Diseases; Listerine; Fluorides; Sodium Fluoride; Cariostatic Agents; Protective Agents; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents