Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-26 @ 7:40 AM
Study NCT ID:
NCT04998292
Status:
UNKNOWN
Last Update Posted:
2021-08-10
First Post:
2021-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Piezo-surgical Implant With Laser
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'split mouth study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-03', 'studyFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2021-08-03', 'lastUpdatePostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of pain', 'timeFrame': '2 hours after surgery'}, {'measure': 'Assessment of pain using visual analog scale', 'timeFrame': '6 hours after surgery'}, {'measure': 'Assessment of pain using visual analog scale', 'timeFrame': '24 hours after surgery'}, {'measure': 'Assessment of pain using visual analog scale', 'timeFrame': '2 days after surgery'}, {'measure': 'Assessment of pain using visual analog scale', 'timeFrame': '3 days after surgery'}, {'measure': 'Assessment of pain using visual analog scale', 'timeFrame': '4 days after surgery'}, {'measure': 'Assessment of pain using visual analog scale', 'timeFrame': '7 days after surgery'}], 'secondaryOutcomes': [{'measure': 'Swelling using swelling score system', 'timeFrame': '2 hours after surgery'}, {'measure': 'Swelling using swelling score system', 'timeFrame': '6 hours after surgery'}, {'measure': 'Swelling using swelling score system', 'timeFrame': '24 hours after surgery'}, {'measure': 'Swelling using swelling score system', 'timeFrame': '2 days after surgery'}, {'measure': 'Swelling', 'timeFrame': '3 days after surgery'}, {'measure': 'Swelling using swelling score system', 'timeFrame': '4 days after surgery'}, {'measure': 'Swelling using swelling score system', 'timeFrame': '7 days after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Effect of Piezo-surgical Implant With Laser on Pain and Swelling in Patients With Missing Teeth']}, 'descriptionModule': {'briefSummary': 'Evaluation of the effect of laser with piezo-surgical device in dental implants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects having good oral hygiene\n* History of bilateral extractions in the lower molar area not less than 6 months ago.\n\nExclusion Criteria:\n\n* Patients with debilitating diseases or bad oral hygiene,\n* Patients with parafunctional habits and patients who are taking analgesics or with alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT04998292', 'briefTitle': 'Piezo-surgical Implant With Laser', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Piezo-surgical Implant Placement With Laser', 'orgStudyIdInfo': {'id': 'REC/82-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low level laser therapy', 'interventionNames': ['Device: Piezo-surgery with low level laser therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Device: Piezo-surgery only']}], 'interventions': [{'name': 'Piezo-surgery with low level laser therapy', 'type': 'DEVICE', 'description': 'Low level laser therapy', 'armGroupLabels': ['Low level laser therapy']}, {'name': 'Piezo-surgery only', 'type': 'DEVICE', 'description': 'Piezo-surgery only', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud Sedky', 'role': 'CONTACT', 'email': 'dr.mahmoud.sedky@gmail.com', 'phone': '01091783307'}], 'facility': 'Mahmoud', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mahmoud Sedky', 'investigatorAffiliation': 'Cairo University'}}}}