Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT05099718
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2021-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Hyaluronic Acid on Oral Mucosal Wound Healing - Focus on Pain and Re-epithelisation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-02', 'studyFirstSubmitDate': '2021-10-09', 'studyFirstSubmitQcDate': '2021-10-21', 'lastUpdatePostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain / discomfort (burning) perception by means of a 100 mm VAS', 'timeFrame': '3 days', 'description': '0 indicates no pain, 100 indicates maximum pain'}, {'measure': 'pain / discomfort (burning) perception by means of a 100 mm VAS', 'timeFrame': '7 days', 'description': '0 indicates no pain, 100 indicates maximum pain'}, {'measure': 'pain / discomfort (burning) perception by means of a 100 mm VAS', 'timeFrame': '14 days', 'description': '0 indicates no pain, 100 indicates maximum pain'}, {'measure': 'pain / discomfort (burning) perception by means of a 100 mm VAS', 'timeFrame': '21 days', 'description': '0 indicates no pain, 100 indicates maximum pain'}], 'secondaryOutcomes': [{'measure': 'pain killer consumption', 'timeFrame': '3 days', 'description': 'amount of pills taken'}, {'measure': 'pain killer consumption', 'timeFrame': '7 days', 'description': 'amount of pills taken'}, {'measure': 'pain killer consumption', 'timeFrame': '14 days', 'description': 'amount of pills taken'}, {'measure': 'pain killer consumption', 'timeFrame': '21 days', 'description': 'amount of pills taken'}, {'measure': 'disturbance while eating or drinking by means of a 100 mm VAS', 'timeFrame': '3 days', 'description': '0 indicates no disturbance, 100 indicates maximum disturbance'}, {'measure': 'disturbance while eating or drinking by means of a 100 mm VAS', 'timeFrame': '7 days', 'description': '0 indicates no disturbance, 100 indicates maximum disturbance'}, {'measure': 'disturbance while eating or drinking by means of a 100 mm VAS', 'timeFrame': '14 days', 'description': '0 indicates no disturbance, 100 indicates maximum disturbance'}, {'measure': 'disturbance while eating or drinking by means of a 100 mm VAS', 'timeFrame': '21 days', 'description': '0 indicates no disturbance, 100 indicates maximum disturbance'}, {'measure': 'taste alteration experience by means of a 100 mm VAS', 'timeFrame': '3 days', 'description': '0 indicates no alteration, 100 indicates maximum alteration'}, {'measure': 'taste alteration experience by means of a 100 mm VAS', 'timeFrame': '7 days', 'description': '0 indicates no alteration, 100 indicates maximum alteration'}, {'measure': 'taste alteration experience by means of a 100 mm VAS', 'timeFrame': '14 days', 'description': '0 indicates no alteration, 100 indicates maximum alteration'}, {'measure': 'taste alteration experience by means of a 100 mm VAS', 'timeFrame': '21 days', 'description': '0 indicates no alteration, 100 indicates maximum alteration'}, {'measure': 'frequency of re-bleeding', 'timeFrame': '3 days', 'description': 'number of events'}, {'measure': 'frequency of re-bleeding', 'timeFrame': '7 days', 'description': 'number of events'}, {'measure': 'frequency of re-bleeding', 'timeFrame': '14 days', 'description': 'number of events'}, {'measure': 'frequency of re-bleeding', 'timeFrame': '21 days', 'description': 'number of events'}, {'measure': 're-epithelialised defect area (by means of standardized photographs)', 'timeFrame': '3 days', 'description': 'mm2'}, {'measure': 're-epithelialised defect area (by means of standardized photographs)', 'timeFrame': '7 days', 'description': 'mm2'}, {'measure': 're-epithelialised defect area (by means of standardized photographs)', 'timeFrame': '14 days', 'description': 'mm2'}, {'measure': 're-epithelialised defect area (by means of standardized photographs)', 'timeFrame': '21 days', 'description': 'mm2'}, {'measure': 're-epithelisation by colorimetric digital assessment of the calibrated photographs', 'timeFrame': '3 days', 'description': 'colorimetric assessment'}, {'measure': 're-epithelisation by colorimetric digital assessment of the calibrated photographs', 'timeFrame': '7 days', 'description': 'colorimetric assessment'}, {'measure': 're-epithelisation by colorimetric digital assessment of the calibrated photographs', 'timeFrame': '14 days', 'description': 'colorimetric assessment'}, {'measure': 're-epithelisation by colorimetric digital assessment of the calibrated photographs', 'timeFrame': '21 days', 'description': 'colorimetric assessment'}, {'measure': 'changes in total and specific bacterial counts', 'timeFrame': '3 days', 'description': 'log values'}, {'measure': 'changes in total and specific bacterial counts', 'timeFrame': '7 days', 'description': 'log values'}, {'measure': 'changes in total and specific bacterial counts', 'timeFrame': '14 days', 'description': 'log values'}, {'measure': 'defect volume fill by overlay of the intraoral scans', 'timeFrame': '3 days', 'description': 'mm3'}, {'measure': 'defect volume fill by overlay of the intraoral scans', 'timeFrame': '7 days', 'description': 'mm3'}, {'measure': 'defect volume fill by overlay of the intraoral scans', 'timeFrame': '14 days', 'description': 'mm3'}, {'measure': 'defect volume fill by overlay of the intraoral scans', 'timeFrame': '21 days', 'description': 'mm3'}, {'measure': 'food restrictions (yes/no)', 'timeFrame': '3 days'}, {'measure': 'food restrictions (yes/no)', 'timeFrame': '7 days'}, {'measure': 'food restrictions (yes/no)', 'timeFrame': '14 days'}, {'measure': 'food restrictions (yes/no)', 'timeFrame': '21 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Soft Tissue Wound Healing']}, 'descriptionModule': {'briefSummary': 'Establishment of a sufficiently wide and thick keratinized gingival/mucosal tissue cuff around teeth/implants is considered of importance for long-term stability. This can more readily be achieved by means of autogenous soft tissue grafts harvested from the palate than with soft tissue substitutes. However, this often implies the creation of an open palatal wound involving secondary intention healing. The aim of this randomized controlled, split-mouth, clinical trial is to assess the effect of a hyaluronic acid containing commercial product on wound healing and patient morbidity after palatal soft tissue harvesting. Altogether, 20 volunteers will be recruited. An individualized splint containing 2 symmetrically located contralateral cylindrical openings will be used for standardized soft tissue harvesting (6 mm in Ø, 2 mm in depth). Soft tissue grafts will be harvested randomly from the right or left side and patients will be monitored for 3 weeks followed by a 1-month wash-out period prior to harvesting the second soft tissue graft from the other side. Participants will randomly start treating the palatal wound either with the test product (GUM Aftaclear Gel, Sunstar Suisse SA, Etoy, Switzerland; 0.3%) or saline solution for 7 days to promote the healing process, which will be reversed for the second round. Patient-related outcomes (morbidity, discomfort, taste alteration, pain killer consumption), frequency of bleeding events, defect closure (area, volume), and microbial colonisation will be recorded and analysed for any differences between the control and test product. Further, in 6 additional volunteers, biopsies of the healing wound are collected in a similar fashion as described above, but with the use of a larger stent in order to harvest also pristine surrounding tissues for histological analysis; biopsies are collected up to 14 days of healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years,\n* systemically healthy,\n* healthy periodontal conditions at the experimental region or conditions not interfering with proper biopsy harvesting,\n* no known sensitivity to HY,\n* no uncontrolled diabetes mellitus,\n* no radiotherapy or chemotherapy,\n* no current pregnancy or breastfeeding,\n* no hormonal diseases,\n* no infectious diseases,\n* no autoimmune diseases or under immunotherapy,\n* no systemic bone disease,\n* no wound healing disorders or acute inflammatory/infectious processes,\n* no systemic diseases with implications on mucous membranes (e.g., Morbus Crohn),\n* no increased risk of bleeding (i.e., patient with coagulation disorders or under anticoagulant therapy, and\n* no heavy smokers (i.e., no regular tobacco consumption \\> 10 cigarettes/day).\n\nExclusion Criteria:\n\n* not meeting the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT05099718', 'briefTitle': 'Effect of Hyaluronic Acid on Oral Mucosal Wound Healing - Focus on Pain and Re-epithelisation', 'organization': {'class': 'OTHER', 'fullName': 'Malmö University'}, 'officialTitle': 'Effect of Hyaluronic Acid on Oral Mucosal Wound Healing - Focus on Pain and Re-epithelisation', 'orgStudyIdInfo': {'id': '2020-01018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyaluronic acid', 'description': 'Application 3-times per day for 7 days.', 'interventionNames': ['Procedure: palatal soft tissue harvesting', 'Device: Hyaluronic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline solution', 'description': 'Application 3-times per day for 7 days.', 'interventionNames': ['Procedure: palatal soft tissue harvesting', 'Other: Saline solution (placebo)']}], 'interventions': [{'name': 'palatal soft tissue harvesting', 'type': 'PROCEDURE', 'description': 'A 6x2mm palatal soft tissue graft will be harvested.', 'armGroupLabels': ['Hyaluronic acid', 'Saline solution']}, {'name': 'Hyaluronic acid', 'type': 'DEVICE', 'description': 'application 3-times per day for 7 days', 'armGroupLabels': ['Hyaluronic acid']}, {'name': 'Saline solution (placebo)', 'type': 'OTHER', 'description': 'application 3-times per day for 7 days', 'armGroupLabels': ['Saline solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Malmo', 'country': 'Sweden', 'facility': 'Faculty of Odontology, Malmo University', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Malmö University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Andreas Stavropoulos', 'investigatorAffiliation': 'Malmö University'}}}}