Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
Study NCT ID:
NCT06212232
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2024-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A New Piezoelectric Technique in Third Molar Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D014095', 'term': 'Tooth, Impacted'}, {'id': 'D014084', 'term': 'Tooth Avulsion'}], 'ancestors': [{'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': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2024-01-17', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', '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 piezosurgery 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 piezosurgery 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 piezosurgery 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 piezosurgery 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 piezosurgery on pain (measured by VAS-score from 0 to 10 point, with 10 as the worst outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['third molar surgery', 'facial swelling', '3D facial swelling evaluation', 'Piezoelectric technique', 'tooth impacted', 'piezosurgery'], 'conditions': ['Tooth Diseases', 'Piezoelectric Technique', 'Tooth, Impacted', 'Tooth Extraction Status Nos', 'Tooth Avulsion', 'Facial Swelling']}, 'descriptionModule': {'briefSummary': 'The present study aims to analyze the effect of the piezoelectric technique in third molar surgery in terms of facial swelling, trismus and pain in a split-mouth randomized controlled clinical trial', 'detailedDescription': 'The present study aims to analyze the effect of of the piezoelectric technique n third molar surgery in terms of facial swelling, trismus and pain 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': 'NCT06212232', 'briefTitle': 'A New Piezoelectric Technique in Third Molar Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Magna Graecia'}, 'officialTitle': 'Efficacy of a New Piezoelectric Technique in Third Molar Surgery and Evaluation of Postoperative Sequelae: a Randomized Split-mouth', 'orgStudyIdInfo': {'id': '123/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Test Group', 'description': 'Use of a new piezoelectric technique in third molar surgery', 'interventionNames': ['Procedure: Piezoelectric surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional: Control Group', 'description': 'Use of the traditional technique in third molar surgery', 'interventionNames': ['Procedure: Piezoelectric surgery']}], 'interventions': [{'name': 'Piezoelectric surgery', 'type': 'PROCEDURE', 'description': 'Application of a new piezoelectric technique in third molar surgery', 'armGroupLabels': ['Experimental: Test Group', 'Traditional: Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88100', 'city': 'Catanzaro', 'state': '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'}}}}