54
Participants
Start Date
April 25, 2023
Primary Completion Date
April 1, 2024
Study Completion Date
April 1, 2024
Carbamide Peroxide Mouthwash
The experinmental mouthwah is a solution containing 4.3% w/v hydrogen carbamide, which breaks down to 1.51% w/v hydrogen peroxide, serving as the active ingredient. Participants rinse (swish and spit) with the mouthwash three times a day for one minute each time, using a 10ml quantity (as indicated by a marking line inside the bottle cap) for a total of 14 days, starting from day 0, i.e. the day of the biopsy (see procedure in the detailed description). Consumption of liquid or solid foods should be avoided for at least thirty minutes following each rinse. Participants are asked to maintain their usual oral hygiene routine. It is a Class IIa, CE-marked medical device made and distributed by Intermed S.A. and Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.
Placebo mouthwash
Placebo mouthwash is a similar (look-and-taste-alike) solution to the experinmental mouthwash made by the same manufacturer, without active ingredients. Participants rinse (swish and spit) with the mouthwash three times a day for one minute each time, using a 10ml quantity (as indicated by a marking line inside the bottle cap) for a total of 14 days, starting from day 0, i.e. the day of the biopsy (see procedure in the detailed description). Consumption of liquid or solid foods should be avoided for at least thirty minutes following each rinse. Participants are asked to maintain their usual oral hygiene routine.
Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry, National and kapodistrian University of Athens, Athens
Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.
INDUSTRY
National and Kapodistrian University of Athens
OTHER