At a glance
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A Randomized Placebo-Controlled Clinical Trial Assessing the Efficacy of a Hydrogen Peroxide Gel (UNISEPT®ORAL GEL) for Oral Wound Healing, Postoperative Symptoms and Oral Hygiene in Patients Undergoing Incisional or Excisional Punch Biopsy of Gingival or Palatal Oral Mucosa
In Brief
A clinical study evaluating Hydrogen Carbamide/Peroxide Gel and Placebo Gel for Wound Heal and 6 related conditions. Completed, enrolled 54 participants across 1 site.
Detailed Summary
This study aims to assess the effectiveness and safety of a hydrogen carbamide/peroxide gel, called UNISEPT® ORAL GEL, in promoting oral wound healing, alleviating postoperative symptoms, and enhancing oral hygiene. Study participants will include individuals with any suspicious lesion in their gums or the roof of their mouth. They will undergo a procedure to remove a small piece of tissue for testing (biopsy) in order to confirm the diagnosis.This is a standardized diagnostic procedure that involves the use of a punch, which is a plastic handpiece with a cylindrical cutting blade. Subsequently, the wound heals naturally without the need for sutures. Researchers are comparing this gel with a placebo (a look-and-taste-alike substance that contains no active ingredients) to see if it is helpful with healing of wounds in the mouth and associated symptoms, improving oral hygiene. Participants randomly get the hydrogen carbamide/peroxide gel or the placebo one to use for 14 days after the biopsy. The researchers will not know which one they are providing as the gel tubes will be identical. Oral wound healing, postoperative symptoms (such as pain, eating and speech difficulties), oral hygiene (dental plaque and gingival inflammation) and quality of life are assessed during a 14-day period after the biopsy. Participants are required to visit the clinic three times, one for the initial biopsy, one at 7 days and one at 14 days after the biopsy. They are asked to fill in some questionnaires, while certain procedures (taking a photo the site of the biopsy) and assessments (like evaluating the dental plaque and gingival inflammation) take place. During the first week they, also, keep a diary of their symptoms, as instructed.
Study Details
Timeline
Interventions
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.
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.