Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT05092633
Status:
UNKNOWN
Last Update Posted:
2021-11-17
First Post:
2021-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Low Level Laser Therapy on Orthodontic Miniscrew Displacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-05-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-09', 'studyFirstSubmitDate': '2021-09-27', 'studyFirstSubmitQcDate': '2021-10-22', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect of low level laser therapy on displacement of miniscrews', 'timeFrame': '4 months', 'description': 'Miniscrews displacement will be assessed after four months of canine retraction using CBCT scan. The head and tail of miniscrew will be measured in relation to anterior nasal spine as a fixed reference point before and after retraction'}], 'secondaryOutcomes': [{'measure': 'effect of LLL application on gingival condition around the miniscrew.', 'timeFrame': '4 months', 'description': 'Gingival inflammation around miniscrew head will evaluated just after placement and at day 7 and 14 before application of retraction force and during days 21, 30, 60 which will be during the period of force application, based on modified gingival index with scores range from 0 to 3 as follows:Score 0 - no signs of inflammation (tissue around head is pink in color).\n\nScore 1 - mild inflammation (tissues are red in color, no bleeding sign). Score 2 - moderate inflammation (tissues are intense red in color, small bleeding signs).\n\nScore 3- severe inflammation (bleeding, evidence of swelling).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Miniscrew'], 'conditions': ['Orthodontic Appliance']}, 'descriptionModule': {'briefSummary': 'EFFECT OF LOW LEVEL LASER THERAPY ON ORTHODONTIC MINISCREW DISPLACEMENT', 'detailedDescription': 'Miniscrews can achieve good anchorage for different types of tooth movements, as intrusion, retraction, and protraction. However, obtaining primary stability is a challenge in their clinical application.Low Level Laser Therapy is suggested to prevent miniscrew displacement. Also previous studies concluded that Low Level Laser Therapy has an effect in stabilizing miniscrew after direct application.\n\nSo the aim of this study is to assess the effect of Low Level Laser Therapy on displacement of miniscrews during canine retraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '22 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 to 22 years old.\n* Permanent dentition.\n* Class I Bimaxillary protrusion and class II devision 1 patients.\n* Good oral hygiene.\n\nExclusion Criteria:\n\n* Medically compromised patients.\n* Chronic renal failure and hormonal disorders as thyroid and parathyroid.\n* Regular use of steroids, barbiturates, anticonvulsants drugs, and thyroid hormone replacements.\n* Tobacco smoking.\n* Any disease or metabolic disorder that can affect bone physiology'}, 'identificationModule': {'nctId': 'NCT05092633', 'acronym': 'Miniscrew', 'briefTitle': 'Effect of Low Level Laser Therapy on Orthodontic Miniscrew Displacement', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effect of Low Level Laser Therapy on Orthodontic Miniscrew Displacement', 'orgStudyIdInfo': {'id': 'Effect of laser on mini screw'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Will have miniscrew only without laser application', 'interventionNames': ['Device: Miniscrew']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Will have miniscrew and laser application', 'interventionNames': ['Device: Miniscrew']}], 'interventions': [{'name': 'Miniscrew', 'type': 'DEVICE', 'otherNames': ['Laser'], 'description': 'Application of laser on miniscrew', 'armGroupLabels': ['Control', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed A Elzoheiry', 'role': 'CONTACT', 'email': 'dr.melzoheiry@gmail.com', 'phone': '01007036198'}], 'facility': 'Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Elzoheiry', 'role': 'CONTACT', 'email': 'Dr.melzoheiry@gmail.com', 'phone': '01007036198'}], 'facility': 'AlexandriaU', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Mohamed A Elzoheiry', 'role': 'CONTACT', 'email': 'dr.melzoheiry@gmail.com', 'phone': '01007036198'}, {'name': 'Mohamed A Elzoheiry', 'role': 'CONTACT', 'email': 'dr.melzoheiry@gmail.com', 'phone': '01064705192'}], 'overallOfficials': [{'name': 'Mohamed A Elzoheiry', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mohamed Elzoheiry', 'investigatorAffiliation': 'Alexandria University'}}}}