N/A
N=24
A Clinical Study to Determine the Safety and Effectiveness of Dentinal Hypersensitivity Treatment With Two Different Toothbrushes
Dentin Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT02513212 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Change From Baseline Air Challenge — -0.409; -0.917 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Potassium Oxalate (Device); Stannous fluoride paste (Drug); Manual toothbrush (Device); Power toothbrush (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Procter and Gamble
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Air Challenge |
-0.409; -0.917 | — |
| SECONDARY Change From Baseline Visual Analog Scale |
-11.000; -28.500 | — |
Summary
This study will determine the effects toothbrush type (power or manual) has on the safety and effectiveness of professional dentinal hypersensitivity treatment with a marketed oxalate-containing solution.
Eligibility Criteria
Inclusion Criteria
- be at least 18 years of age;
- provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- complete a photography consent agreement pertaining to the collection and use of non-identifying intraoral photographs;
- be in good general health as determined by the Investigator/designee; and
- have at least one tooth with a Schiff sensitivity score of at least 1 in response to the cool air challenge.
Exclusion Criteria
- self-reported pregnancy or nursing;
- severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
- active treatment of periodontitis;
- any diseases or conditions that might interfere with the safe completion of the study; or
- an inability to undergo any study procedures.
Data sourced from ClinicalTrials.gov (NCT02513212). 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.