protocolSection identificationModule nctId: NCT06309719, orgStudyIdInfo id: 339479, briefTitle: Hyaluronic Acid and Polynucleotides for Supra-bony Defects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Queen Mary University of London, class: OTHER, collaborators name: Geistlich Pharma AG, descriptionModule briefSummary: The goal of this pilot study is to describe the early wound healing molecular events and the vascularization pattern associated with the treatment of supra-bony defects with access flap alone or in association with a combined formulation of hyaluronic acid and polydeoxyribonucleotides gel., conditionsModule conditions: Periodontal Diseases, conditions: Wound Heal, conditions: Periodontal Inflammation, conditions: Periodontal Pocket, conditions: Periodontal Attachment Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Periodontal Access Flap (AF) + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA), interventions name: Periodontal Access Flap (AF), outcomesModule primaryOutcomes measure: Early wound healing molecular events through GCF, primaryOutcomes measure: Early gingival tissue vascularization pattern when supra-bony defects are treated with AF, in association or not with PNHA, secondaryOutcomes measure: Periodontal parameters and periodontal inflamed surface area (PISA) on the teeth involved in the surgery, secondaryOutcomes measure: Probing pocket depth (PPD), secondaryOutcomes measure: Gingival recession (REC), secondaryOutcomes measure: Clinical attachment level (CAL), secondaryOutcomes measure: Suppuration, secondaryOutcomes measure: Gingival phenotype, secondaryOutcomes measure: Keratinized tissue (KT), secondaryOutcomes measure: Full mouth plaque score (FMPS), secondaryOutcomes measure: Full mouth bleeding score (FMBS), secondaryOutcomes measure: Early Healing Index (EHI), secondaryOutcomes measure: Gingival morphometric changes, secondaryOutcomes measure: Oral impact on daily performance (OIDP), secondaryOutcomes measure: Dentine/root sensitivity, secondaryOutcomes measure: Food impaction, secondaryOutcomes measure: Patient perception about therapy, secondaryOutcomes measure: Global ratings of Periodontal Health and Quality of Life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Barts Health NHS Trust Dental Hospital, city: London, zip: E1 1BB, country: United Kingdom, contacts name: Vandana Luthra, role: CONTACT, phone: +44(0)207 882 6348, email: BHNT.Clinicaloralresearchcentre@nhs.net, contacts name: Elena Calciolari, DDS, MS, PhD, role: CONTACT, email: e.calciolari@qmul.ac.uk, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Centre for Oral Clinical Research (COCR), city: London, zip: E1 2AD, country: United Kingdom, contacts name: Vandana Luthra, role: CONTACT, phone: +44(0)207 882 6348, email: BHNT.Clinicaloralresearchcentre@nhs.net, contacts name: Elena Calciolari, DDS, MS, PhD, role: CONTACT, email: e.calciolari@qmul.ac.uk, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False