Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 3:33 PM
Study NCT ID:
NCT06777069
Status:
COMPLETED
Last Update Posted:
2025-01-15
First Post:
2025-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Leucocyte- and Platelet-Rich Fibrin on Palatal Wound Healing After Free Gingival Graft Harvesting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007958', 'term': 'Leukocyte Count'}], 'ancestors': [{'id': 'D001772', 'term': 'Blood Cell Count'}, {'id': 'D002452', 'term': 'Cell Count'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2025-01-10', 'studyFirstSubmitQcDate': '2025-01-10', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Donor site pain', 'timeFrame': 'Postoperative day 1 and weeks 1, 2, 3, and 4', 'description': 'Pain at the donor site was assessed using a VAS (Visual Analogue Scale) of 0-10.'}], 'secondaryOutcomes': [{'measure': 'Donor site burning sensation', 'timeFrame': 'Postoperative day 1 and weeks 1, 2, 3, and 4', 'description': 'Burning sensation at the donor site was assessed using a VAS(Visual Analogue Scale) of 0-10.'}, {'measure': 'Donor site bleeding', 'timeFrame': 'Postoperative days 1, 3, 5, and 7', 'description': 'Postoperative bleeding at the palatal donor site was assessed using a scale of 0 to 3: 0 = no bleeding, 1 = mild bleeding, 2 = moderate bleeding, and 3 = severe bleeding.'}, {'measure': 'Donor site color matching with the adjacent healthy tissue', 'timeFrame': 'Postoperative day 1 and weeks 1, 3, and 6', 'description': 'The color matching of the donor site with the adjacent healthy tissue was assessed using a scale of 0 to 10: 0 = no match, 10 = perfect match.'}, {'measure': 'Donor site clinical healing', 'timeFrame': 'Postoperative weeks 1, 2, 3, and 4', 'description': 'Clinical wound healing at the donor site was scored from 0 to 5 based on the consistency of the clinical appearance with the expected course of healing. Deviations from the expected appearance were recorded as "-1". The expected healing course was as follows: Days 1-7: Fibrin covers the wound surface with petechiae at the wound edge; Days 7-14: Decreased fibrin coverage; Days 14-21: Epithelialization of the defect area; Day 21 onwards: Complete healing.'}, {'measure': 'Donor site wound area', 'timeFrame': 'At baseline, on postoperative day 3, and at weeks 1, 2, 3, and 4', 'description': 'Donor site wound areas were measured digitally from standardized photographs taken using an occlusal mirror.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['free gingival graft, platelet rich fibrin, wound healing'], 'conditions': ['Wound Healing']}, 'descriptionModule': {'briefSummary': 'Autogenous palatal free gingival graft harvesting presents challenges for patients due to the increased risk of postoperative morbidity related to a second intraoral surgical wound that heals with secondary intention. This study aimed to evaluate the efficacy of the application of leukocyte- and platelet-rich fibrin (L-PRF) membrane to the palatal donor site on wound healing, hemostasis, and pain control after free gingival graft harvesting. Twenty-six adult patients with insufficient attached gingiva underwent soft tissue augmentation using free gingival grafts harvested from the palate. Patients were randomized to either an L-PRF group or a control group. In the L-PRF group, the L-PRF membrane was sutured to the donor sites, whereas in the control group, donor sites healed by secondary intention. Postoperative evaluations were conducted on days 1, 3, 5, and 7 and at weeks 2, 3, 4, 5, and 6. Donor sites were evaluated clinically for pain, burning sensation, bleeding, wound healing, and color match to adjacent tissues. Donor site wound areas were analyzed using digital images.', 'detailedDescription': 'Soft tissue grafting techniques using autogenous free gingival grafts and connective tissue grafts are reliable and predictable procedures that are commonly used to increase the dimensions of keratinized gingiva. These tehniques are indicated in situations such as shallow vestibular depth, gingival recession, and inadequate peri-implant attached gingiva. Although free soft tissue grafts can be harvested from various intraoral sites, the keratinized gingiva of the hard palate in the premolar-molar region is the most commonly used donor site. However, harvesting tissue from the palate presents challenges for patients, including a second intraoral surgical wound and an increased risk of postoperative morbidity. The palatal wound, which typically heals over two to four weeks by secondary intention, often causes significant patient discomfort due to pain, burning sensation, prolonged bleeding, and delayed healing, often caused by secondary irritation.\n\nLeukocyte- and platelet-rich fibrin (L-PRF), a second-generation platelet concentrate, was developed for oral and maxillofacial surgery in 2001 by Choukroun et al. Polymerization without any biochemical activation, which occurs in a manner comparable to the natural coagulation process, produces a strong fibrin matrix resistant to rapid resorption. Compressing this fibrin matrix creates a strong, suture-resistant membrane that can be fixed to the wound edges and provides a stable barrier against the oral environment.\n\nWhile L-PRF has shown promise in several applications in regenerative dentistry, randomized controlled clinical trials evaluating L-PRF membrane as an adjunct for donor site wound healing in free gingival grafting procedures are limited in the literature. This study aimed to evaluate the efficacy of L-PRF membrane as a palatal wound dressing in promoting wound healing, hemostasis, and pain control at palatal donor sites following free gingival grafting procedures.\n\nPatients requiring soft tissue augmentation with a free gingival graft due to inadequate keratinized attached gingiva were included in this study. Patients were randomized to either an L-PRF group (n=13) or a control group (n=13). All procedures were performed by a single clinician to reduce variability in surgical technique. After achieving adequate anesthesia, a recipient site was prepared to receive the graft in areas lacking sufficient attached gingiva. This procedure involved an incision at the mucogingival junction followed by blunt dissection to separate the epithelium from the underlying connective tissue, creating a vascular bed for graft integration and survival. A sterile paper template was created to match the dimensions of the recipient site. The paper template was positioned on the palatal mucosa in the premolar/molar region, and the graft margins were outlined with a scalpel. A 1-2 mm thick graft consisting of epithelium and a thin layer of connective tissue was carefully harvested by moving the blade parallel to the mucosal surface. The free gingival graft was carefully oriented on the recipient site, with the epithelium facing outward and the connective tissue in contact with the recipient bed. It was then sutured to ensure close contact between the graft and the underlying tissue to prevent any movement that could compromise revascularization and lead to graft failure. In the L-PRF group, 10 ml of venous blood was drawn from the antecubital vein of the patient using sterile, anticoagulant-free vacutainer tubes and immediately centrifuged at 3000 rpm for 10 minutes. A fibrin clot was structured in the middle of the tube, just between the red corpuscles at the bottom and the acellular plasma at the top. The L-PRF layer was isolated and compressed into a flexible membrane using its special box. The L-PRF membrane was shaped to fit the donor site wound and placed as a single layer, ensuring complete contact with the underlying tissue. It was secured at the wound corners using 5-0 bioabsorbable polyglactin sutures to minimize displacement during the healing process.\n\nParticipants were evaluated on days 1, 3, 5, and 7, and weeks 2, 3, 4, 5, and 6 postoperatively to monitor wound healing and complications at the palatal donor site. An examiner recorded subjective parameters (pain, burning sensation), clinically evaluated objective parameters (postoperative bleeding, wound healing, and color matching with the adjacent healthy tissue), obtained donor site photographs, and performed wound area measurements using digital image analysis. Blinding of patients to L-PRF treatment was not feasible due to ethical concerns regarding the collection of blood samples in the control group, and blinding of investigators during digital image analysis and clinical assessment was also not feasible due to the nature of the surgical procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients requiring soft tissue augmentation with a free gingival graft due to inadequate keratinized attached gingiva (shallow vestibular depth, gingival recession)\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Patients with systemic medical conditions that may compromise wound healing (e.g., uncontrolled diabetes mellitus, hypertension, blood disorders, rheumatoid arthritis)\n* Patients receiving medication that may affect periodontal tissues (e.g., antibiotics, immunomodulatory drugs, steroids, non-steroidal anti-inflammatory drugs) within the last 3 months before surgery\n* Patients receiving anticoagulant and antiaggregant therapy\n* Smokers\n* Pregnancy or breastfeeding\n* History of palatal free gingival graft harvesting procedure'}, 'identificationModule': {'nctId': 'NCT06777069', 'briefTitle': 'Effect of Leucocyte- and Platelet-Rich Fibrin on Palatal Wound Healing After Free Gingival Graft Harvesting', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Enhanced Palatal Wound Healing With Leucocyte- and Platelet-Rich Fibrin After Free Gingival Graft Harvesting: A Controlled Prospective Clinical Trial', 'orgStudyIdInfo': {'id': 'IMUH-OMFS-SG-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Leucocyte and platelet rich fibrin (L-PRF)', 'description': 'The L-PRF membrane was sutured to the palatal donor sites', 'interventionNames': ['Procedure: Leucocyte and platelet rich fibrin membrane application']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The palatal donor sites healed by secondary intention without L-PRF application'}], 'interventions': [{'name': 'Leucocyte and platelet rich fibrin membrane application', 'type': 'PROCEDURE', 'description': "Leukocyte and platelet rich membrane, obtained by centrifuging 10 ml of venous blood collected from the patient's antecubital vein, was sutured to the donor sites.", 'armGroupLabels': ['Leucocyte and platelet rich fibrin (L-PRF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06490', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Baskent University, Faculty of Dentistry, Çankaya/Ankara', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Serap Gulsever, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medipol University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '6 months after application', 'ipdSharing': 'YES', 'description': 'We are planning to share our data, after publication of the study', 'accessCriteria': 'via e-mail'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Assistant Professor', 'investigatorFullName': 'Serap Gulsever', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}