Assessing the Efficacy of a Carbamide Peroxide Mouthwash for Oral Wound Healing, Oral Hygiene and Xerostomia Relief

NACompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

April 25, 2023

Primary Completion Date

April 1, 2024

Study Completion Date

April 1, 2024

Conditions
Wound HealOral DrynessPostoperative PainSjogren's SyndromeBiopsy WoundMouth; WoundMouth DrynessDental PlaqueGingival Inflammation
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (1)

11527

Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry, National and kapodistrian University of Athens, Athens

All Listed Sponsors
collaborator

Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.

INDUSTRY

lead

National and Kapodistrian University of Athens

OTHER