Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-03 @ 10:15 PM
Study NCT ID:
NCT03857035
Status:
COMPLETED
Last Update Posted:
2019-05-08
First Post:
2019-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMPARISON OF PIEZOSURGERY AND CONVENTIONAL ROTARY INSTRUMENTS IN IMPACTED THIRD MOLAR SURGERY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014313', 'term': 'Trismus'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D013035', 'term': 'Spasm'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-07', 'studyFirstSubmitDate': '2019-02-22', 'studyFirstSubmitQcDate': '2019-02-26', 'lastUpdatePostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All the patients will be given a form containing verbal rating scale ranging from 0 to 5, showing the degree of swelling.', 'timeFrame': 'Up to 1 week', 'description': 'The edema measurement will be done during the one week after surgery.'}], 'secondaryOutcomes': [{'measure': 'Pain will be assessed using a visual analogue scale.', 'timeFrame': 'Up to 1 week', 'description': 'The level of postoperative pain will be evaluated using a 10-cm visual analogue scale , with zero representing no pain and 10 representing excruciating pain. Pain measurement will be done preoperatively, postoperative 2nd day, 7th day after the surgery.'}, {'measure': 'Trismus will be evaluated using a caliper at maximum mouth opening.', 'timeFrame': 'Up to 1 week', 'description': 'Trismus will be assessed by measuring the maximum interincisal opening (in millimetres) - the distance between the incisal margin of the upper and lower central incisors. Trismus measurement will be done preoperatively, postoperative 2nd day, 7th day after the surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trismus', 'piezosurgery', 'pain', 'swelling'], 'conditions': ['Impacted Third Molar Tooth']}, 'descriptionModule': {'briefSummary': "The purpose is to compare the effects of piezosurgery and conventional rotary instruments on postoperative pain, swelling, trismus and patients' comfort after mandibular third molar surgery.", 'detailedDescription': 'The investigators plan a prospective and split mouth study. Thirty patients will be randomly selected. Inclusion criteria were being older than 18 of age, having asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) fully covered with mucosa and bone, and being otherwise medically healthy.\n\nOne side of the patients will be randomly selected and labeled as "experimental group". In experimental group, impacted third molar will be extracted using piezosurgery. The other side will be accepted as "control group". In the control group, impacted third molar will be extracted using conventional rotary instruments.There will at least one month between two surgeries. The investigators will compare postoperative pain, swelling, trismus and patients\' comfort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria were being older than 18 of age, having asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) fully covered with mucosa and bone, and being otherwise medically healthy.\n\nExclusion Criteria:\n\n* Exclusion criteria were as follows: Alcohol abuse, smoking, pregnancy, and presence of acute severe periodontitis.'}, 'identificationModule': {'nctId': 'NCT03857035', 'briefTitle': 'COMPARISON OF PIEZOSURGERY AND CONVENTIONAL ROTARY INSTRUMENTS IN IMPACTED THIRD MOLAR SURGERY', 'organization': {'class': 'OTHER', 'fullName': 'Konya Necmettin Erbakan Üniversitesi'}, 'officialTitle': 'A PROSPECTIVE SPLIT MOUTH CLINICAL STUDY: OF PIEZOSURGERY AND CONVENTIONAL ROTARY INSTRUMENTS IN IMPACTED THIRD MOLAR SURGERY', 'orgStudyIdInfo': {'id': 'NEU3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Piezosurgery group', 'description': 'One side of the patients will be randomly selected and labeled as "experimental group". In experimental group, impacted third molar will be extracted using piezosurgery.', 'interventionNames': ['Other: Piezosurgery group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Rotary Instruments Group', 'description': 'The other side will be accepted as "control group". In the control group, impacted third molar will be extracted using conventional rotary instruments.', 'interventionNames': ['Other: Piezosurgery group']}], 'interventions': [{'name': 'Piezosurgery group', 'type': 'OTHER', 'description': 'Piezosurgery technique will be examined about impacted third molar surgery.', 'armGroupLabels': ['Piezosurgery group', 'Rotary Instruments Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42050', 'city': 'Konya', 'state': 'Karatay', 'country': 'Turkey (Türkiye)', 'facility': 'Necmettin Erbakan University, Faculty of Dentistry', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}, {'zip': '42050', 'city': 'Konya', 'state': 'Karatay', 'country': 'Turkey (Türkiye)', 'facility': 'Necmettin Erbakan University', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'Dilek Menziletoglu, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Necmettin Erbakan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya Necmettin Erbakan Üniversitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Dilek Menziletoglu', 'investigatorAffiliation': 'Konya Necmettin Erbakan Üniversitesi'}}}}