Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT05339620
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2022-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Implant Driver Facilitated Micro-osteo Perforation on the Rate of Tooth Movement.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-15', 'studyFirstSubmitDate': '2022-04-15', 'studyFirstSubmitQcDate': '2022-04-15', 'lastUpdatePostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing rate of canine retraction between intervention and non-intervention side.', 'timeFrame': '28 days', 'description': 'distance from cusp tip of canine to mesio-buccal cusp tip of molar taken by digital vernier caliper.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['micro-osteoperforations, tooth movement, implant driver'], 'conditions': ['Tooth Movement Techniques']}, 'referencesModule': {'references': [{'pmid': '27894545', 'type': 'BACKGROUND', 'citation': 'Cheung T, Park J, Lee D, Kim C, Olson J, Javadi S, Lawson G, McCabe J, Moon W, Ting K, Hong C. Ability of mini-implant-facilitated micro-osteoperforations to accelerate tooth movement in rats. Am J Orthod Dentofacial Orthop. 2016 Dec;150(6):958-967. doi: 10.1016/j.ajodo.2016.04.030.'}, {'pmid': '33984223', 'type': 'BACKGROUND', 'citation': 'Ozkan TH, Arici S. The effect of different micro-osteoperforation depths on the rate of orthodontic tooth movement: A single-center, single-blind, randomized clinical trial. Korean J Orthod. 2021 May 25;51(3):157-165. doi: 10.4041/kjod.2021.51.3.157.'}, {'pmid': '31155698', 'type': 'BACKGROUND', 'citation': 'Aboalnaga AA, Salah Fayed MM, El-Ashmawi NA, Soliman SA. Effect of micro-osteoperforation on the rate of canine retraction: a split-mouth randomized controlled trial. Prog Orthod. 2019 Jun 3;20(1):21. doi: 10.1186/s40510-019-0274-0.'}, {'pmid': '35024875', 'type': 'BACKGROUND', 'citation': 'Bolat Gumus E, Kinsiz E. Effects of miniscrew-facilitated micro-osteoperforations on the rate of orthodontic tooth movement : A split-mouth, randomized controlled trial. J Orofac Orthop. 2023 Apr;84(Suppl 2):104-110. doi: 10.1007/s00056-021-00371-6. Epub 2022 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'we have conducted a split-mouth randomized clinical trial to study effects of implant induced micro-osteoperforations on the rate of tooth movement during canine retraction.', 'detailedDescription': 'The experimental group will receive implant driver facilitated microosteoperforation on one side of the mouth( according to split mouth design) decided by random allocation.\n\nAfter 3 months of extraction of upper first premolar ( according to planned orthodontic treatment), 3 microosteoperforation will be done with implant in an implant driver distal to canine. Surgical procedure will be done in local anesthesia, no flap will be raised. Alginate impressions will be taken before the procedure and 28 days after canine retraction has started, to measure the difference between rate of canine retraction on both sides. Measurement was done by a digital vernier caliper,'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Male and female\n\n * Age 18- 45 years\n * Class 2 div 1\n * No systemic disease\n * No radiographic evidence of bone loss\n * No history of periodontal therapy\n * No current active periodontal disease\n * No smoking\n * No gingivitis or untreated caries\n * Probing depth \\< 4mm in all teeth\n * Gingival index \\< 1mm\n * Plaque index \\< 1mm\n\nExclusion Criteria:\n\n* Long term use of antibiotics, phenytoin,cyclosporine, anti inflammatory drugs, systemic corticosteroids and calcium channel blockers.\n* Poor oral hygiene for more than 2 visits.\n* Extreme skeletal class 2 malocclusion, overjet \\> 10mm, anb\\> 7\n* Systemic disease\n* Evidence of bone loss\n* Past periodontal disease\n* Current periodontal disease\n* Smoking\n* Gingivitis and caries\n* Probing depth \\> 4mm'}, 'identificationModule': {'nctId': 'NCT05339620', 'briefTitle': 'Effect of Implant Driver Facilitated Micro-osteo Perforation on the Rate of Tooth Movement.', 'organization': {'class': 'OTHER', 'fullName': 'Bahria University'}, 'officialTitle': 'Effect of Implant Driver Facilitated Micro-osteo Perforations on the Rate of Tooth Movement.', 'orgStudyIdInfo': {'id': 'ERC 05/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mop group', 'description': 'a group of patients with a class 2 divsion 1 dental malocclusion, overjet greater than 9 mm, extraction of upper first premolars planned, and it has been 3 months post extraction and before canine retraction is commenced.', 'interventionNames': ['Procedure: implant driver facilitated micro-osteoperforations']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'mop group ( same)', 'description': 'a group of patients with a class 2 divsion 1 dental malocclusion, overjet greater than 9 mm, extraction of upper first premolars planned, and it has been 3 months post extraction and before canine retraction is commenced.', 'interventionNames': ['Procedure: implant driver facilitated micro-osteoperforations']}], 'interventions': [{'name': 'implant driver facilitated micro-osteoperforations', 'type': 'PROCEDURE', 'otherNames': ['micro-osteoperforations by any other means.'], 'description': '3 micro-osteoperforations(in a vertical pattern) are done on the randomly allocated experimental side , distal to canine under local anesthesia. the other side of the mouth is used as a control.\n\nalginate impression is taken before the intervention .', 'armGroupLabels': ['mop group', 'mop group ( same)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75200', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Bahria University Medical and Dental College', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bahria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'DR MARIA HABIB', 'investigatorAffiliation': 'Bahria University'}}}}