protocolSection identificationModule nctId: NCT06370260, orgStudyIdInfo id: INTM-PMCF-UNIGEL, secondaryIdInfos id: 571/13.02.2023, type: OTHER, domain: INTERMED S.A, briefTitle: Assessing the Efficacy of a Hydrogen Peroxide Gel for Oral Wound Healing and Oral Hygiene, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-02, primaryCompletionDateStruct date: 2023-12-27, completionDateStruct date: 2023-12-27, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: National and Kapodistrian University of Athens, class: OTHER, collaborators name: Ioulia And Irene Tseti Pharmaceutical Laboratories S.A., descriptionModule briefSummary: 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., conditionsModule conditions: Wound Heal, conditions: Postoperative Pain, conditions: Biopsy Wound, conditions: Wound; Mouth, conditions: Quality of Life, conditions: Dental Plaque, conditions: Gingival Inflammation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This trial is designed as a prospective, randomized, placebo-controlled, triple blinded, with two parallel groups and an equal allocation ratio in all groups. In this study, the intervention consists of delivery of a hydrogen carbamide/peroxide gel or placebo gel, made by the same manufacturer., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: Hydrogen Carbamide/Peroxide Gel, interventions name: Placebo Gel, outcomesModule primaryOutcomes measure: Assessment of wound healing based on Percentage Healing Index on day 14, primaryOutcomes measure: Assessment of wound healing based on Percentage Healing Index on day 7, secondaryOutcomes measure: Postoperative symptoms (pain, eating and speech difficulty) during the first week (at home), secondaryOutcomes measure: Postoperative symptoms (pain, eating and speech difficulty) on day 7, secondaryOutcomes measure: Postoperative symptoms (pain, eating and speech difficulty) on day 14, secondaryOutcomes measure: Wound healing based on clinical signs, secondaryOutcomes measure: Oral Hygiene - Dental Plaque: Sextant Plaque Index, secondaryOutcomes measure: Oral Hygiene - Gingival Inflammation: Sextant Gingival Index, secondaryOutcomes measure: Oral Health Related Quality of Life, otherOutcomes measure: Adverse Events, otherOutcomes measure: Participant's comments and satisfaction regarding the provided treatment/use of the products, otherOutcomes measure: Compliance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry, city: Athens, state: Attiki, zip: 11527, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, hasResults: False