protocolSection identificationModule nctId: NCT06363955, orgStudyIdInfo id: INTM-PMCF-UNIMOUTH, secondaryIdInfos id: 750/13.02.2023, type: OTHER, domain: National and Kapodistrian University of Athens, briefTitle: Assessing the Efficacy of a Hydrogen Peroxide Mouthwash for Oral Wound Healing, Oral Hygiene and Xerostomia Relief, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-25, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National and Kapodistrian University of Athens, class: OTHER, collaborators name: Ioulia And Irene Tseti Pharmaceutical Laboratories S.A., descriptionModule briefSummary: The aim of this study is to evaluate the efficacy and safety of a hydrogen carbamide/peroxide mouthwash, named UNISEPT® MOUTHWASH, regarding oral wound healing, postoperative symptoms, xerostomia (dry mouth) and oral hygiene improvement. Study participants have reported dry mouth and are scheduled for a diagnostic biopsy of minor labial salivary glands to investigate Sjögren's Syndrome, following consultation with their rheumatologist. This is a standardized diagnostic procedure that leads to healing by primary intention (i.e. wound edges are closely re-approximated with sutures).Researchers are comparing this mouthwash 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 dry mouth and/or oral hygiene. Participants randomly get the hydrogen carbamide/peroxide mouthwash or the placebo one to use for 14 days after the biopsy. The investigators will not know which one they are providing as the bottles will be identical.Oral wound healing, postoperative symptoms (such as pain, eating and speech difficulties), oral hygiene (dental plaque and gingival inflammation), improvement of dry mouth 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 consultation and the biopsy, one at 7 days and one at 14 days after the biopsy. They are asked to fill in some questionnaires, while certain procedures (such as measuring saliva) 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: Oral Dryness, conditions: Postoperative Pain, conditions: Sjogren's Syndrome, conditions: Biopsy Wound, conditions: Mouth; Wound, conditions: Mouth Dryness, 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 mouthwash or placebo mouthwash, 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 Mouthwash, interventions name: Placebo mouthwash, outcomesModule primaryOutcomes measure: Assessment of wound healing based on the modified Landry Healing Index on day 14, primaryOutcomes measure: Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 14, primaryOutcomes measure: Assessment of wound healing based on the modified Landry Healing Index on day 7, primaryOutcomes measure: Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) 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 the incision/wound length, secondaryOutcomes measure: Subjective oral dryness symptoms (8-item VAS questionnaire), secondaryOutcomes measure: Observed (objective) signs of oral dryness, secondaryOutcomes measure: Change in Unstimulated Saliva Flow Rate, secondaryOutcomes measure: Oral Hygiene - Dental Plaque: Full-Mouth Plaque Index, secondaryOutcomes measure: Oral Hygiene - Gingival Inflammation: Full Mouth Gingival Index, secondaryOutcomes measure: Oral Health Related Quality of Life, secondaryOutcomes measure: Assessment of swelling in the biopsy area, 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, National and kapodistrian University of Athens, city: Athens, state: Attiki, zip: 11527, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, hasResults: False