Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-27 @ 1:19 PM
Study NCT ID:
NCT06165692
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2023-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Platelet-rich-fibrin in Lower Third Molar Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014095', 'term': 'Tooth, Impacted'}, {'id': 'D014084', 'term': 'Tooth Avulsion'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018677', 'term': 'Tooth Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2023-11-15', 'studyFirstSubmitQcDate': '2023-12-08', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Facial swelling qualitative analysis', 'timeFrame': 'Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery', 'description': 'To compare the effectiveness of PRF in reducing facial swelling using qualitative three-dimensional analysis (measured by colorimetric variation given by the overlapping volumes) .'}, {'measure': 'Facial swelling quantitative analysis - volumetric differences', 'timeFrame': 'Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery', 'description': 'To compare the effectiveness of PRF in reducing facial swelling using quantitative three-dimensional analysis ( volumes measured in cm3) .'}, {'measure': 'Facial swelling quantitative analysis - linear differences', 'timeFrame': 'Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery', 'description': 'To compare the effectiveness of PRF in reducing facial swelling using quantitative three-dimensional analysis (linear differences measured in cm2) .'}], 'secondaryOutcomes': [{'measure': 'Trismus analysis', 'timeFrame': 'Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery', 'description': 'To assess the effects of PRF administration on trismus (measured in cm)'}, {'measure': 'Pain analysis with Visual analogue scale (VAS)', 'timeFrame': 'Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery', 'description': 'To assess the effects of PRF administration on pain (measured by VAS-score from 0 to 10 point, with 10 as the worst outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['third molar surgery', 'facial swelling', '3D facial swelling evaluation', 'PRF', 'tooth impacted', 'platelet rich fibrin'], 'conditions': ['Facial Swelling', 'Tooth Position Anomalies', 'Tooth, Impacted', 'Tooth Extraction Status Nos', 'Tooth Avulsion']}, 'descriptionModule': {'briefSummary': 'The present study aims to analyze the effect of PRF (Platelet-rich-fibrin) in terms of facial swelling, trismus and pain after surgical removal of mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial.', 'detailedDescription': 'The present study aims to analyze the effect of PRF (Platelet-rich-fibrin) in terms of facial swelling, trismus and pain after surgical removal of mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial. Facial swelling will be assessed using an innovative three-dimensional digital technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '32 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 to 32 years who required both M3M extractions were recruited\n* Good health status\n* Indication to surgical extraction of both M3M\n* Complete root formation\n* Surgical risk level classified as "Conventional" or "Moderate" according to Daugela et al. classification\n\nExclusion Criteria:\n\n* Person under the age of 18 or over 32\n* Allergy or contraindications to administration of corticosteroids\n* Acute infection in any of the teeth to be extracted\n* Patients with chronic liver disease, diabetes, immune system dysfunction, or haematological disease\n* Pregnancy or breastfeeding\n* History of treatment with antiresorptive drugs\n* Chronic kidney disease'}, 'identificationModule': {'nctId': 'NCT06165692', 'briefTitle': 'The Use of Platelet-rich-fibrin in Lower Third Molar Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'University Magna Graecia'}, 'officialTitle': 'The Use of Platelet-rich-fibrin in Lower Third Molar Surgery: a Split-mouth Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Group', 'description': 'Placement of PRF in the post-extraction socket after third molar surgery', 'interventionNames': ['Biological: PRF']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No positioning PRF in the post-extraction socket after third molar surgery'}], 'interventions': [{'name': 'PRF', 'type': 'BIOLOGICAL', 'description': 'Post-operative PRF placement in the post-extraction socket after third molar surgery', 'armGroupLabels': ['Test Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Magna Graecia University of Catanzaro', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amerigo Giudice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Amerigo Giudice', 'investigatorAffiliation': 'University Magna Graecia'}}}}