Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-21 @ 3:50 AM
Study NCT ID:
NCT04175405
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2019-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-level Laser Therapy With a 635nm Diode Laser on Orthodontic Mini-implants Stability.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008312', 'term': 'Malocclusion, Angle Class II'}], 'ancestors': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, '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': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-21', 'studyFirstSubmitDate': '2019-11-21', 'studyFirstSubmitQcDate': '2019-11-21', 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stability of orthodontic mini-implants', 'timeFrame': '60 days', 'description': 'The mini-implants stability was estimated employing a Periotest device (Medzintechnik Gulden e K, Modautal, Germany). The Periotest measurement system includes the sound formed from contact between an object and a metallic tapping bar in a handpiece, which is electromagnetically driven and electronically verified. The Periotest response detection is analyzed through a fast Fourier transform (FFT) algorithm. Simply put, the Periotest answer to tapping is estimated by an accelerometer and then analyzed. The signal generated by tapping is then transformed to a value called the Periotest value (PTV), which depends on the damping characteristics of the peri-implant tissue. \\[27\\] The Periotest Test values (PTVs) are based on a numerical scale ranging from -8 to +50, defined by mathematical computation. The lower Periotest values indicate higher implant stability and thereupon the higher absorption effect of the target objects.'}], 'secondaryOutcomes': [{'measure': 'Pain level', 'timeFrame': '24 hours', 'description': 'Immediately after the mini-implants placement, each patient received a questionnaire for individual pain assessment (the numeric rating scale, NRS-11, grade level 0-10). The maximum pain level was measured at both sides of the maxilla during the first day after the treatment. The NRS-11 scale consists of a conscious, subjective assessment of the pain experienced; therefore, it is used in the case of patients over ten years old. A rating of 0 signifies no pain, 1-3 represents mild pain, 4-6 moderate pain, and 7-10 severe pain.'}, {'measure': 'mini-implants loss', 'timeFrame': '60 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ATP, biostimulation, micro-screw, Periotest, semiconductor laser'], 'conditions': ['Malocclusion, Angle Class II']}, 'descriptionModule': {'briefSummary': 'The study aimed to clinically estimate an influence of a 635nm diode laser on the primary and secondary stability of orthodontic mini-implants placed in a maxilla, to assess mini-implants failure rate (mini-implant loss) and to evaluate a pain level after the treatment. The randomized clinical split-mouth trial included 15 subjects, 30 implants (Dual Top Anchor System, Seoul, Korea) with a diameter 1.4mm and length of 10mm. Mini-implants were placed in the area of the attached gingiva between the second premolar and first molar teeth 2 mm below the mucogingival junction of both sides of the maxilla in 20 patients (13 women and 7 men; age: 32.5 ± 6.1 years).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with class II malocclusion defect requiring lateral maxillary teeth distillation based on the use of orthodontic mini-implant;\n* the patients were treated first time using fixed orthodontic appliance;\n* no systemic diseases;\n* were not using anti-inflammatory drugs;\n\nExclusion Criteria:\n\n* had used antibiotics in the previous 24 months;\n* smokers;\n* had history of radiotherapy,\n* taking bisphosphonate medication'}, 'identificationModule': {'nctId': 'NCT04175405', 'briefTitle': 'Low-level Laser Therapy With a 635nm Diode Laser on Orthodontic Mini-implants Stability.', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw Medical University'}, 'officialTitle': 'Low-level Laser Therapy With a 635nm Diode Laser Affects Orthodontic Mini-implants Stability. A Randomized Clinical Split-Mouth Trial.', 'orgStudyIdInfo': {'id': 'WroclawMU2212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Right side of the maxilla', 'description': 'The 635-nm laser parameters; dose: 10J per point (20J/cm2), time: 100 sec per point, 2 points (irradiation on a buccal, and a palatal side of the alveolus/implant), the total energy per session 20J.', 'interventionNames': ['Procedure: Irradiation of implants with 635nm laser']}, {'type': 'NO_INTERVENTION', 'label': 'Left side of the maxilla'}], 'interventions': [{'name': 'Irradiation of implants with 635nm laser', 'type': 'PROCEDURE', 'description': 'Irradiation of implants with 635nm laser with a dose of 10J', 'armGroupLabels': ['Right side of the maxilla']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wschowa', 'country': 'Poland', 'facility': 'Private Dental Healtcare', 'geoPoint': {'lat': 51.80705, 'lon': 16.31663}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jacek Matys', 'investigatorAffiliation': 'Wroclaw Medical University'}}}}