Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT04758702
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2021-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Clinical Impact of L-PRF, H-PRF or the Use of Surgical Stent on Palatal Donor Site Healing.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-28', 'studyFirstSubmitDate': '2021-02-08', 'studyFirstSubmitQcDate': '2021-02-12', 'lastUpdatePostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.', 'timeFrame': '5 days', 'description': 'The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.'}, {'measure': 'The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.', 'timeFrame': '10 days', 'description': 'The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.'}, {'measure': 'The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.', 'timeFrame': '14 days', 'description': 'The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.'}, {'measure': 'The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.', 'timeFrame': '21 days', 'description': 'The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.'}], 'secondaryOutcomes': [{'measure': 'The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.', 'timeFrame': '5 days', 'description': 'The secondary outcome is to compare the post-operative discomfort between the three groups during the healing period using the Visual Analogue Scale and Analgesic consumption. The visual analog scale is a validated, subjective measure for acute and chronic pain; with (0) indicates no pain and (10) indicates worst pain possible. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain", which is the (0) and "worst pain possible", which is the (10). Also, the patient will write down his/her analgesic consumption, including the frequency and the amount used.'}, {'measure': 'The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.', 'timeFrame': '10 days', 'description': 'The secondary outcome is to compare the post-operative discomfort between the three groups during the healing period using the Visual Analogue Scale and Analgesic consumption. The visual analog scale is a validated, subjective measure for acute and chronic pain; with (0) indicates no pain and (10) indicates worst pain possible. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain", which is the (0) and "worst pain possible", which is the (10). Also, the patient will write down his/her analgesic consumption, including the frequency and the amount used.'}, {'measure': 'The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.', 'timeFrame': '14 days', 'description': 'The secondary outcome is to compare the post-operative discomfort between the three groups during the healing period using the Visual Analogue Scale and Analgesic consumption. The visual analog scale is a validated, subjective measure for acute and chronic pain; with (0) indicates no pain and (10) indicates worst pain possible. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain", which is the (0) and "worst pain possible", which is the (10). Also, the patient will write down his/her analgesic consumption, including the frequency and the amount used.'}, {'measure': 'The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.', 'timeFrame': '21 days', 'description': 'The secondary outcome is to compare the post-operative discomfort between the three groups during the healing period using the Visual Analogue Scale and Analgesic consumption. The visual analog scale is a validated, subjective measure for acute and chronic pain; with (0) indicates no pain and (10) indicates worst pain possible. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain", which is the (0) and "worst pain possible", which is the (10). Also, the patient will write down his/her analgesic consumption, including the frequency and the amount used.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lack of Keratinized Gingiva']}, 'descriptionModule': {'briefSummary': 'A Randomized, Three Parallel Arms Clinical Trial to evaluate s the clinical impact of L-PRF vs H-PRF vs Palatal stent on the healing of the donor palatal site.', 'detailedDescription': 'A Randomized, Three Parallel Arms Clinical Trial. The primary objective is to assess the clinical impact of L-PRF vs H-PRF vs Palatal stent on the healing of the donor palatal site by comparing the percentage of re-epithelization of the palatal donor site at 5, 10, 14 and 21 days using a standardized intraoral palatal photo.\n\nThe secondary objective is to compare the post op discomfort between the three groups during the healing period daily for 2 weeks using the Visual Analogue Scale (VAS) and Analgesic consumption.\n\nAll subjects from the University of Kentucky College of Dentistry clinics. Subjects that are coming increasing the width of keratinized tissue or for the treatment of gingival recession, and match the inclusion criteria will be told about the research and offered the opportunity to participate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects between 18-65 years of age.\n2. Subjects need FGG or de-epithelialized Connective tissue graft\n3. Good oral hygiene (Plaque and bleeding indexes \\<20%).\n4. Subjects can withstand alginate impression or wear a retainer.\n5. No other surgery or need for analgesics at the same site.\n\nExclusion Criteria:\n\n1. Subjects with any systemic disorders that might compromise wound healing (Uncontrolled diabetes mellitus, rheumatoid arthritis, osteoporosis, chemotherapy/radiotherapy and immunological disorders).\n2. Smokers\n3. Patients not maintaining oral hygiene (plaque score \\>20%)\n4. Pregnant or breastfeeding females.\n5. Inability to provide informed consent.\n6. Grafts thickness more than 2mm will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04758702', 'briefTitle': 'The Clinical Impact of L-PRF, H-PRF or the Use of Surgical Stent on Palatal Donor Site Healing.', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'The Clinical Impact of L-PRF, H-PRF or the Use of Surgical Stent on Palatal Donor Site Healing: A Randomized, Three Parallel Arms Clinical Trial.', 'orgStudyIdInfo': {'id': '63364'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GROUP 1', 'description': 'L-PRF membranes will be placed on the palatal donor site to help stabilizing the blood clot and release of growth factors that help in deceasing the discomfort wound healing.', 'interventionNames': ['Biological: L-PRF (Leucocyte- platelet rich fibrin)']}, {'type': 'EXPERIMENTAL', 'label': 'GROUP 2', 'description': 'H-PRF membranes will be placed on the palatal donor site to help stabilizing the blood clot and release of growth factors that help in deceasing the discomfort wound healing.', 'interventionNames': ['Biological: H-PRF (Horizontal -platelet rich fibrin)']}, {'type': 'EXPERIMENTAL', 'label': 'GROUP 3', 'description': 'A surgical stent will be delivered to cover the surgical site and apply pressure on the wound site.', 'interventionNames': ['Device: Surgical stent']}], 'interventions': [{'name': 'L-PRF (Leucocyte- platelet rich fibrin)', 'type': 'BIOLOGICAL', 'description': "Leucocyte-Platelet rich fibrin is a high density fibrin clot. it serves as a biological healing matrix by supporting cell migration and cytokine release, expanding the range of its potential applications greatly. Patient's own blood is centrifuged using (Intra-spin) FDA approved centrifuge on 45 degrees angle on 2700 rpm for 12 minutes.", 'armGroupLabels': ['GROUP 1']}, {'name': 'H-PRF (Horizontal -platelet rich fibrin)', 'type': 'BIOLOGICAL', 'description': 'Platelet rich fibrin is a high density fibrin clot. it serves as a biological healing matrix by supporting cell migration and cytokine release, expanding the range of its potential applications greatly.Horizontally centrifuged platelet rich fibrin using (Bio-prf) centrifuge on 700 g force for 8 minutes. On a horizontal centrifugation, the cells separate much more efficiently throughout the entire membrane. This leads to better layer separation and also favors cells that are evenly distributed throughout the PRF clot.', 'armGroupLabels': ['GROUP 2']}, {'name': 'Surgical stent', 'type': 'DEVICE', 'otherNames': ['Essix retainer'], 'description': 'An essix surgical stent will be obtained using a high vacuum suction and used to protect the denuded donor site after suturing the wound. (Biostar® Scan/Biostar®V) will be used to make the stent.', 'armGroupLabels': ['GROUP 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Mohanad Al-Sabbagh, DDS, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abdo Y Ismail', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Post-graduate Periodontics Resident', 'investigatorFullName': 'Abdo Y Ismail', 'investigatorAffiliation': 'University of Kentucky'}}}}