Assessing the Efficacy of a Hydrogen Peroxide Gel for Oral Wound Healing and Oral Hygiene - Trial NCT06370260
Access comprehensive clinical trial information for NCT06370260 through Pure Global AI's free database. This phase not specified trial is sponsored by National and Kapodistrian University of Athens and is currently Completed. The study focuses on Wound Heal,Postoperative Pain,Biopsy Wound,Wound; Mouth,Quality of Life,Dental Plaque,Gingival Inflammation. Target enrollment is 54 participants.
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Study Focus
Hydrogen Carbamide/Peroxide Gel
Interventional
device
Sponsor & Location
National and Kapodistrian University of Athens
Timeline & Enrollment
N/A
May 02, 2023
Dec 27, 2023
Primary Outcome
Assessment of wound healing based on Percentage Healing Index on day 14,Assessment of wound healing based on Percentage Healing Index on day 7
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06370260
Device Trial