N/A
N=60
Effectiveness of Two Water-Based Potassium Oxalate Desensitizers
Dentin Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT02192307 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Change From Baseline Air Challenge — -0.98; -0.97 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Potassium oxalate (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Procter and Gamble
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Air Challenge |
-0.98; -0.97 | — |
| SECONDARY Change From Baseline Visual Analog Scale |
-38.10; -32.62 | — |
Summary
This study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.
Eligibility Criteria
Inclusion Criteria
- Provide written informed consent to participate in the study
- Be at least 18 years of age
- Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study
- Agree to refrain from participating in any other oral/dental product studies for the duration of the study
- Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study
- Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study
- Agree to comply with study/product usage instructions; and
- Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the Cold Air Sensitivity Schiff scale during screening
Exclusion Criteria
- Gross oral neglect or urgent dental treatment needs
- Severe periodontal disease and/or generalized mobility
- Active treatment for periodontitis
- Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study
- Self-reported pregnancy or nursing
Data sourced from ClinicalTrials.gov (NCT02192307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.