Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-01-01 @ 5:44 PM
Study NCT ID:
NCT05375357
Status:
COMPLETED
Last Update Posted:
2022-12-19
First Post:
2022-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet Rich Fibrin in Soft Tissue Healing After Implant Uncovering
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-15', 'studyFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2022-05-10', 'lastUpdatePostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete re-epithelialization of the wound of donor area (CWE)', 'timeFrame': '4 weeks', 'description': 'Time needed to obtain a complete re-epithelialization of the wound of donor area'}], 'secondaryOutcomes': [{'measure': 'Post-Operative Discomfort (D)', 'timeFrame': '4 weeks', 'description': 'Evaluation of post-operative discomfort using Visual Analogue Scale (VAS).The scale is represented by a straight horizontal line of fixed length, generally 10 cm. Extremities are defined as extreme limits of the parameter to be measured, oriented from left (worst) to right (best).'}, {'measure': 'Changes in Feedind Habits (CFH)', 'timeFrame': '4 weeks', 'description': "Evaluation of changes in patients' feedind habits using Visual Analogue Scale (VAS).The scale is represented by a straight horizontal line of fixed length, generally 10 cm. Extremities are defined as extreme limits of the parameter to be measured, oriented from left (worst) to right (best)."}, {'measure': 'Consumption of Analgesics (AU)', 'timeFrame': '4 weeks', 'description': 'Assessment of postoperative pain by the number of analgesics taken'}, {'measure': 'Alteration of Sensivity (AS)', 'timeFrame': '4 weeks', 'description': 'Evaluation of alteration of sensivity on donor area'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Platelet Rich Fibrin', 'Wound Healing', 'Implant Uncovering'], 'conditions': ['Healing Surgical Wounds']}, 'descriptionModule': {'briefSummary': "This study represents a prospective, controlled and randomized clinical trial assessing the effects of L-PRF on the healing time of the donor area and on the patient's postoperative morbidity in the 4 weeks following the Apically Positioned Flap (APF) procedure in the uncovering phase of two-stage implants.\n\nA total of 40 patients were recruited and divided into two groups. The implant uncovering procedure in the test group was performed with APF and application of L-PRF on the donor area. Patients in the control group, on the other hand, were treated with APF alone, leaving the donor area to heal by secondary intention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* to have at least one implant in the maxilla with a quantity of vestibular keratinized gingiva \\< 2 mm\n* to be in good systemic health\n* to have a good oral hygiene (FMPS and FMBS \\< 20%)\n\nExclusion Criteria:\n\n* systemic diseases: coagulation disorders; medications affecting periodontal status in the previous 6 months; pregnancy or lactation;\n* smoking habits;\n* peri-implant surgery on the experimental sites.'}, 'identificationModule': {'nctId': 'NCT05375357', 'briefTitle': 'Platelet Rich Fibrin in Soft Tissue Healing After Implant Uncovering', 'organization': {'class': 'OTHER', 'fullName': "G. d'Annunzio University"}, 'officialTitle': 'Evaluation of Healing Time and Postoperative Morbidity After Implant Uncovering With Vestibularly Repositioned Flap Associated With Leucocyte Platelet Rich Fibrin (L-PRF): a Randomized and Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '19102021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APF + L-PRF', 'description': 'Application of a layer of L-PRF to protect the donor area after uncovering implant procedure using Apically Positioned Flap (APF).', 'interventionNames': ['Procedure: Application of L-PRF on the donor area']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'APF without L-PRF', 'description': 'The donor area is left to heal by secondary intention after APF in the implant uncovering procedure.', 'interventionNames': ['Procedure: Secondary intention healing of the donor area']}], 'interventions': [{'name': 'Application of L-PRF on the donor area', 'type': 'PROCEDURE', 'description': 'After implant uncovering procedure with apically positioned flap, the donor area is covered with a layer of L-PRF', 'armGroupLabels': ['APF + L-PRF']}, {'name': 'Secondary intention healing of the donor area', 'type': 'PROCEDURE', 'description': 'After implant uncovering procedure with apically positioned flap, the donor area is left to heal by secondary intention', 'armGroupLabels': ['APF without L-PRF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66100', 'city': 'Chieti', 'country': 'Italy', 'facility': "G. D'Annunzio University", 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "G. d'Annunzio University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full time professor', 'investigatorFullName': 'Michele Paolantonio', 'investigatorAffiliation': "G. d'Annunzio University"}}}}