Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT07033351
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2025-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Platelet Rich Fibrin Layers on Peri-implant Tissue Phenotype
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D056690', 'term': 'Prolactin-Releasing Hormone'}], 'ancestors': [{'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcomes assessor was blinded to the group allocation to prevent bias during the evaluation of soft tissue width and crestal bone measurements.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2025-06-13', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ridge Width Changes (RW)', 'timeFrame': 'Baseline (preoperative), immediate postoperative, 6 weeks, and 12 weeks', 'description': 'The changes in Ridge Width is measured at the reference points using a digital vernier caliper.'}, {'measure': 'Bone Width (BW)', 'timeFrame': 'Baseline (preoperative), and 12 weeks postoperatively', 'description': 'Measured in millimeters by subtracting the buccal and lingual mucosal thickness from the ridge width.'}, {'measure': 'Change in width of keratinized tissue (KTW)', 'timeFrame': 'Baseline (preoperative), 6 weeks, and 12 weeks', 'description': 'Measured in millimeters at the mid-buccal aspect of the implant site using an endodontic rotary file and digital vernier caliper.'}, {'measure': 'Keratinized Tissue Thickness (KTT)', 'timeFrame': 'Baseline (preoperative), and 12 weeks postoperatively', 'description': 'Measured in millimeters at the buccal, crestal and lingual reference points using a periodontal probe and a digital vernier caliper.'}, {'measure': 'Radiographic Mucosal Thickness (RT)', 'timeFrame': 'Baseline (preoperative), immediate postoperative, 6 weeks, and 12 weeks', 'description': 'Measured in millimeters on periapical radiographs using digital software from the crestal bone level to the crest of crestal oral mucosa 5 mm away from the height distal surface of the adjacent tooth on the mesial side of the implant.'}, {'measure': 'Crestal Bone Height (BH)', 'timeFrame': 'Immediate postoperative, 6 weeks, and 12 weeks', 'description': 'Measured in millimeters on periapical radiographs using digital software from the second serration on the mesial side of the implant to the crest of the bone.'}], 'secondaryOutcomes': [{'measure': 'Plaque Index (PI)', 'timeFrame': 'Baseline (preoperative), 6 weeks, and 12 weeks', 'description': "O'Leary plaque index"}, {'measure': 'Gingival Index (GI)', 'timeFrame': 'Baseline (preoperative), 6 weeks, and 12 weeks', 'description': 'Gingival Bleeding Index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Platelet-Rich Fibrin (PRF)', 'Dental Implant', 'Keratinized Mucosa', 'Crestal Bone Level', 'Soft Tissue Healing'], 'conditions': ['Dental Implant', 'Platelet Rich Fibrin', 'Keratinized Mucosa', 'Crestal Bone Loss']}, 'descriptionModule': {'briefSummary': 'The present investigation seeks to determine how varying quantities of Platelet-Rich Fibrin (PRF) membranes influence the repair of both gingival and osseous tissues adjacent to dental implants. A secondary objective is to establish whether the incorporation of PRF contributes to enhanced stability of the soft-tissue cover and more effective retention of alveolar bone over an extended period.\n\nCentral to the study are two specific inquiries: Does the application of PRF correlate with an increase in the width and thickness of keratinized mucosa surrounding the implant? Is there a dose-response relationship such that the use of multiple PRF layers yields superior maintenance of bone height compared with a single layer or no PRF at all?\n\nTo address these questions, clinicians will juxtapose three treatment groups: one receiving no PRF, another receiving a single membrane, and a third receiving a triple-layer graft. Healing parameters will be measured before surgery and again at 6-week and 12-week checkpoints, allowing direct appraisal of outcome changes across the comparative cohorts.\n\nEach participant will ultimately be allotted to one of the experimental arms by random assignment, thus mitigating selection bias. Routine follow-up examinations and radiographic imaging, will be used to track healing progress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults (male or female) over 18 years of age.\n* Partially edentulous spaces.\n* No history of bone augmentation procedures in the implant site.\n* Good oral health, as measured by:\n* Calibrated gingival bleeding index (≤10%)\n* O'Leary plaque index (\\<10%)\n\nExclusion Criteria:\n\n* Bleeding disorders.\n* Compromised immune systems.\n* Excessive smoking or alcohol consumption.\n* Poor oral hygiene.\n* Diabetes.\n* Inability to attend follow-up visits."}, 'identificationModule': {'nctId': 'NCT07033351', 'briefTitle': 'The Effect of Platelet Rich Fibrin Layers on Peri-implant Tissue Phenotype', 'organization': {'class': 'OTHER', 'fullName': 'Al-Mustansiriyah University'}, 'officialTitle': 'The Effect of Platelet Rich Fibrin Layers on Peri-implant Tissue Phenotype', 'orgStudyIdInfo': {'id': 'MUOSU-202131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '0 PRF', 'description': 'Each implant placed in this group did NOT have PRF membrane placed over the implant.', 'interventionNames': ['Procedure: Dental implant placement without PRF']}, {'type': 'EXPERIMENTAL', 'label': '1 PRF', 'description': 'Each implant placed in this group had ONE PRF membrane placed over the implant.', 'interventionNames': ['Biological: Single-layer PRF membrane application']}, {'type': 'EXPERIMENTAL', 'label': '3 PRF', 'description': 'Each implant placed in this group had THTEE STACKED PRF membranes placed over the implant.', 'interventionNames': ['Biological: Triple-layer PRF membrane application']}], 'interventions': [{'name': 'Dental implant placement without PRF', 'type': 'PROCEDURE', 'description': 'Standard dental implant placement procedure with flap elevation and suturing, without the application of any PRF membrane over the implant site.', 'armGroupLabels': ['0 PRF']}, {'name': 'Single-layer PRF membrane application', 'type': 'BIOLOGICAL', 'description': 'PRF membrane prepared via centrifugation is applied as a single layer over the implant site following implant placement before flap closure.', 'armGroupLabels': ['1 PRF']}, {'name': 'Triple-layer PRF membrane application', 'type': 'BIOLOGICAL', 'description': 'Three autologous PRF membranes prepared via centrifugation are stacked and applied as a 3-layer membrane over the implant site before flap closure.', 'armGroupLabels': ['3 PRF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41002', 'city': 'Mosul', 'state': 'Nenavah', 'country': 'Iraq', 'facility': 'University of Mosul / College of Dentistry', 'geoPoint': {'lat': 36.335, 'lon': 43.11889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Mustansiriyah University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmed Mahir Tawfeeq Karakchi', 'investigatorAffiliation': 'Al-Mustansiriyah University'}}}}