Status:
COMPLETED
Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity
Lead Sponsor:
GlaxoSmithKline
Conditions:
Dentin Sensitivity
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 2 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2014
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT02226562
Start Date
September 2 2014
End Date
December 5 2014
Last Update
August 27 2018
Active Locations (1)
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1
GSK Investigational Site
Fort Wayne, Indiana, United States, 46825