Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT06213467
Status:
COMPLETED
Last Update Posted:
2024-01-19
First Post:
2024-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using Diode Laser in 2nd Stage of Implant.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D054023', 'term': 'Lasers, Semiconductor'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '15 patients that have at least two dental implants in jaws.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-09', 'studyFirstSubmitDate': '2024-01-09', 'studyFirstSubmitQcDate': '2024-01-09', 'lastUpdatePostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain perceived by the patient.', 'timeFrame': 'recordings were done immediately at time of exposure , after 2 , 5 ,7 days postsurgical.', 'description': 'Pain was measured using visual analogue scale from 0-10, filled by the patient'}], 'secondaryOutcomes': [{'measure': 'need for injectable anesthesia', 'timeFrame': 'at time of operation treatment', 'description': 'need for anesthesia done when patient feels pain after application of local anesthesia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diode laser', 'dental implant', 'local anasthesia'], 'conditions': ['Dental Implant Exposure Using Diode Laser']}, 'descriptionModule': {'briefSummary': 'Dental Implants that are teeth replacements usually place with two stages. In the second stage the implant fixture, (which is the body that inserted in the bone is exposed to place the artificial tooth), is exposed using surgical blade, however; an alternative method using diode laser may be used. This study aimed to compare the two methods in relation to pain anticipated by the patients and the need for local anesthesia usage.', 'detailedDescription': 'Second-stage implant exposure involves removing soft tissue above the dental implant, as a part of the implant procedures to replace the missing teeth which can be done either by using diode laser or traditional method This study included fifteen patients, aged between 18 and 70 years old. Implant exposure was performed on 15 patients has at least two implants in two groups: group 1 with a diode laser at 940nm and group 2 with the traditional method performed either using a puncture, flap, or incision in 5 private clinics and one governmental run hospital in city of Baghdad/ Iraq.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 1. Describe the target population and the criteria for their inclusion. Patients indicated for fixed implant treatment with conventional Implant procedure with implant insertd before (3-6) months by using two stage dental implant.\n\n2\\. Treatment with two or more implant in same patient. 3. Patients aged from 18 to 70 years of both the gender with the presence of adequate osseointegration and healthy keratinized tissue surrounding the implant site.\n\nExclusion Criteria:\n\n* 1\\. Patient have single implant. 2. Expose dental implant or already have gingival former. 3. Poor oral hygiene. 4. Failure implant osseointegration to bone.'}, 'identificationModule': {'nctId': 'NCT06213467', 'briefTitle': 'Using Diode Laser in 2nd Stage of Implant.', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': 'Pain Perception and Evaluated Injectable Anesthesia Needed by Using Pulsating Diode Laser 940nm in Second Stage Implant Exposure Versus Traditional Methods', 'orgStudyIdInfo': {'id': '1375'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A and B', 'description': 'Each patient in which two implants have already been inserted are exposed, the first implant expose by using traditional methods , the second one expose by using diode laser 940nm .', 'interventionNames': ['Device: diode laser 940nm']}], 'interventions': [{'name': 'diode laser 940nm', 'type': 'DEVICE', 'description': 'Exposure for the two implants was done at the same visit, with one implant being exposed using diode laser and the other implant using traditional method', 'armGroupLabels': ['A and B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10071', 'city': 'Baghdad', 'state': 'Al-Jadiriya', 'country': 'Iraq', 'facility': 'laser institute for postgraduate studies, University of Baghdad', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'will be provided when needed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Baghdad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Msc student', 'investigatorFullName': 'Saad Mahmood Jameel', 'investigatorAffiliation': 'University of Baghdad'}}}}