Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-02-20 @ 6:03 PM
Study NCT ID:
NCT04055935
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2019-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Full Thickness Mucoperiosteal Flap Versus Low Level Laser in Orthodontic Tooth Movement Acceleration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008644', 'term': 'Mesial Movement of Teeth'}], 'ancestors': [{'id': 'D014085', 'term': 'Tooth Migration'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-07', 'size': 974661, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-08-09T04:47', 'hasProtocol': False}, {'date': '2019-08-07', 'size': 556980, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-09T04:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'split mouth study design, side intervention and other side for control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-18', 'studyFirstSubmitDate': '2019-07-30', 'studyFirstSubmitQcDate': '2019-08-12', 'lastUpdatePostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of orthodontic tooth movement acceleration determination by measuring the rate of maxillary canine retraction', 'timeFrame': 'the rate of retraction( distance from the first day of retraction to the end of retraction/ time)) it was with total time frame 24 weeks for starting of retraction', 'description': 'measure the rate of canine retraction on series of study models'}], 'secondaryOutcomes': [{'measure': 'clinical mesial movement of first maxillary molar measured by millimeter on the 3D model', 'timeFrame': 't0(start of canine retraction) to 24 months', 'description': 'amount of mesial movement of first maxillary molar after 24 month'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mesial Movement of Teeth']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the effect of using full thickness mucoperiosteal flap (FTMPF) elevation only versus low level laser therapy (LLLT) on acceleration of orthodontic tooth movement.', 'detailedDescription': 'This study was a split mouth design study included 32 side according to sample size calculation. Those sides were divided into 2 groups. Group 1divided into (group 1a: 8 sides with FTMPF, group 1b:8 sides control). Group 2(group 2 a: 8 sides with LLLT, group 2b: 8 sides control). Extraction of the first maxillary premolars followed by canine retraction in the extraction space with maximum anchorage were indicated. FTMPF was elevated from the mesial interdental papilla of maxillary canine to the mesial interdental papilla of second maxillary premolar. LLLT was applied at 3,7,14,28.56 days of retraction. During retraction study model for all patients were taken at 2ed, 6th, 14th,16th weeks and at the end of retraction (I1,I2,I3,I4,I5 or overall interval). 3D laser scanning and digital superimposition was done to measure the rate of canine retraction and anchorage loss.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* o Free of any syndromes affecting the head region or any craniofacial injuries.\n\n * No history of previous orthodontic treatment\n * All of the permanent dentition present excluding third molars.\n * Good oral hygiene before starting treatment.\n * Cases indicated for extraction of the maxillary first premolars and canine retraction into the extraction space with maximum anchorage.\n * Malocclusion cases that allow initial stage of leveling and alignment without extraction.\n\nExclusion Criteria:\n\n* o Patients with systemic diseases especially bleeding disorders and osteoporosis.\n\n * History of administration of corticosteroids, exogenous hormones and non-steroidal anti-inflammatory drugs (all drugs interfere with OTM).\n * Presence of previous history of oral surgeries in maxillary arch.'}, 'identificationModule': {'nctId': 'NCT04055935', 'briefTitle': 'Full Thickness Mucoperiosteal Flap Versus Low Level Laser in Orthodontic Tooth Movement Acceleration', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Evaluation of the Effect of Full Thickness Mucoperiosteal Flap Versus Low Level Laser in Orthodontic Tooth Movement Acceleration', 'orgStudyIdInfo': {'id': "Doctor's degree research"}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'full thickness mucoperiosteal flap', 'description': 'A full thickness mucoperiosteal flap (FTMPF) was reflected on FTMPF side at the maxillary canine/premolar region by the same surgeon for all patients following the same procedures.', 'interventionNames': ['Procedure: elevation of full thickness mucoperiosteal flap']}, {'type': 'EXPERIMENTAL', 'label': 'low level laser therapy', 'description': 'LLLT was done using a diode soft laser (Epic X, BioLase, USA). It is a semiconductor diode soft laser. Active medium is In-Ga-As with 940nm wave length', 'interventionNames': ['Device: low level laser therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control for Full thickness mucoperiosteal flap', 'description': 'Control for Full thickness mucoperiosteal flap, in which canine retraction was done in a conventional method'}, {'type': 'NO_INTERVENTION', 'label': 'control for Low level laser therapy group', 'description': 'Control for Low level laser therapy , in which canine retraction was done in a conventional method'}], 'interventions': [{'name': 'elevation of full thickness mucoperiosteal flap', 'type': 'PROCEDURE', 'description': 'A free gingival sulcular incision was done from the distal surface of maxillary second premolar to the mesial side of the maxillary canine. A releasing oblique incision was done including the interdental papilla between maxillary canine and lateral incisor extending to the mucogingival junction just beyond the attached mucosa. The flap reflection extended beyond the canine root apex. A FTMPF reflection was done with mucoperiosteal elevator. Free sulcus incision was done to allow elevation of palatal mucosa by tunneling technique on the palatal gingiva of maxillary canine.', 'armGroupLabels': ['full thickness mucoperiosteal flap']}, {'name': 'low level laser therapy', 'type': 'DEVICE', 'description': 'LLLT was done using a diode soft laser (Epic X, BioLase, USA). It is a semiconductor diode soft laser. Active medium is In-Ga-As with 940nm wave length. LLLT protocol was using active laser tip (bleaching tip)', 'armGroupLabels': ['low level laser therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7118', 'city': 'Cairo', 'state': 'Naser City', 'country': 'Egypt', 'facility': 'Faculty of dentistry ,Al-Azhar Univerisity', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohsena a arazik, orthodontist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Azhar University'}]}, 'ipdSharingStatementModule': {'url': 'https://drive.google.com/open?id=1VGIPJwCULeNnotdILJ4o5znvMF5pdPIw', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'by today,()30July 2019', 'ipdSharing': 'YES', 'description': 'the data will be shared the weekly rate and distance of canine retraction, the amount of maxillary canine mesial movement and the periodontal pocket depth around the maxillary canine', 'accessCriteria': 'Google drive'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of orthodontics', 'investigatorFullName': 'Mohsena Ahmad', 'investigatorAffiliation': 'Al-Azhar University'}}}}