N/A
N=30
A Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene
Dentin Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT02221349 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Change From Baseline Air Challenge — -1.643; -1.500 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Potassium oxalate (Device); Sodium fluoride paste (Drug); Stannous fluoride paste (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Procter and Gamble
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Air Challenge |
-1.643; -1.500 | — |
| SECONDARY Change From Baseline Visual Analog Scale |
-29.82; -24.67 | — |
Summary
This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.
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 confidentiality disclosure agreement
- Be in good general health as determined by the Investigator/designee
- Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the 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
- Fixed facial orthodontic appliances
- A history of kidney stones
- Known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
- Any diseases or conditions that might interfere with the safe completion of the study
- An inability to undergo any study procedures.
Data sourced from ClinicalTrials.gov (NCT02221349). 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.