At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Determination of the Oral Irritation and Sensitization Potential of Two Experimental Potassium Oxalate Containing Mouthrinses
In Brief
A clinical study evaluating Potassium Oxalate without Fluoride, Potassium Oxalate with Fluoride, and 1 other intervention for Oral Manifestations. Completed, enrolled 80 participants across 1 site.
Detailed Summary
This study is 25 days long. People participating in this study will be asked to brush their teeth two times a day. People will be assigned to a mouthwash and will rinse four times a day at the site for five days. A dentist or dental hygienist will look at the mouth, teeth, tongue and gums to make sure the mouthwash does not irritate the mouth. After Day 5 of the study, people will continue to brush two times a day and will return on Day 24 to have their mouth looked at again. People without irritation in their mouth will rinse 4 times a day at the clinical site. People will return to the clinical site the next day and have a final oral exam in which the dentist or dental hygienist will look at the mouth for irritation.
Study Details
Timeline
Interventions
1.40% Potassium Oxalate Sensitive Mouthwash without fluoride - Rinse with 10ml for 60 seconds, four times daily successively at 1 hour intervals for five days
1.40% Potassium Oxalate Sensitive Mouthwash with fluoride - Rinse with 20ml for 60 seconds, four times daily successively at 1 hour intervals for five days
Rinse with comparator mouthwash 20ml for 30 seconds, four times daily successively at 1 hour intervals for five days