Assessing the Efficacy of a Hydrogen Peroxide Gel for Oral Wound Healing and Oral Hygiene

NACompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

May 2, 2023

Primary Completion Date

December 27, 2023

Study Completion Date

December 27, 2023

Conditions
Wound HealPostoperative PainBiopsy WoundWound; MouthQuality of LifeDental PlaqueGingival Inflammation
Interventions
DEVICE

Hydrogen Carbamide/Peroxide Gel

"UNISEPT® ORAL GEL is an oral gel containing 10% w/v urea peroxide which releases 3.50% w/w hydrogen peroxide, glycerin, propylene glycol, carbopol, disodium EDTA, sodium saccharin, methyl salicylate, menthol, and water, serving as the active ingredient.~Participants should apply the gel to the biopsy area and the corresponding sextant teeth three times daily, leaving it on for five minutes without rinsing, for a total of 14 days, beginning on 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 gel application.Participants are asked to maintain their usual oral hygiene routine.~UNISEPT® ORAL GEL 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 Gel

"Placebo gel is a similar (look-and-taste-alike) product to UNISEPT® ORAL GEL, made by the same manufacturer, without active ingredients, containing glycerin, propylene glycol, carbomer, menthol, sodium saccharin, methyl salicylate, triethanolamine.~Participants are called upon to apply the gel in exactly the same way as the experimental product, i.e apply the gel to the biopsy area and the corresponding sextant teeth three times daily, leaving it on for five minutes without rinsing, for a total of 14 days, beginning on day 0."

Trial Locations (1)

11527

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

All Listed Sponsors
collaborator

Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.

INDUSTRY

lead

National and Kapodistrian University of Athens

OTHER

NCT06370260 - Assessing the Efficacy of a Hydrogen Peroxide Gel for Oral Wound Healing and Oral Hygiene | Biotech Hunter | Biotech Hunter