Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-01-03 @ 9:21 AM
Study NCT ID:
NCT04999150
Status:
COMPLETED
Last Update Posted:
2021-08-17
First Post:
2021-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Corticotomy and Micro-Osteoperforation During Canine Retraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Each patient was randomly assigned an identification number (S1-S13) by picking a sealed envelope. The randomization of IDs to the right or left side for MOP was accomplished with a 1:1 allocation ratio, using a computer-generated research randomizer.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a split-mouth randomized clinical trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-10', 'studyFirstSubmitDate': '2021-08-09', 'studyFirstSubmitQcDate': '2021-08-09', 'lastUpdatePostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Canine retraction', 'timeFrame': '3 months', 'description': 'Amount of tooth movement (in mm) attained by the maxillary canines after retracting them'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Corticotomy; MOP; Tooth movement'], 'conditions': ['Malocclusion, Class I/II']}, 'referencesModule': {'availIpds': [{'id': 'B0710118', 'url': 'https://irbrcm.rcm.upr.edu/', 'type': 'Study Protocol'}], 'references': [{'pmid': '29655409', 'type': 'BACKGROUND', 'citation': 'Li Y, Jacox LA, Little SH, Ko CC. Orthodontic tooth movement: The biology and clinical implications. Kaohsiung J Med Sci. 2018 Apr;34(4):207-214. doi: 10.1016/j.kjms.2018.01.007. Epub 2018 Feb 3.'}, {'pmid': '21300255', 'type': 'BACKGROUND', 'citation': 'Aboul-Ela SM, El-Beialy AR, El-Sayed KM, Selim EM, El-Mangoury NH, Mostafa YA. Miniscrew implant-supported maxillary canine retraction with and without corticotomy-facilitated orthodontics. Am J Orthod Dentofacial Orthop. 2011 Feb;139(2):252-9. doi: 10.1016/j.ajodo.2009.04.028.'}, {'pmid': '6345475', 'type': 'BACKGROUND', 'citation': 'Frost HM. The regional acceleratory phenomenon: a review. Henry Ford Hosp Med J. 1983;31(1):3-9. No abstract available.'}, {'pmid': '26599115', 'type': 'BACKGROUND', 'citation': 'Verna C. Regional Acceleratory Phenomenon. Front Oral Biol. 2016;18:28-35. doi: 10.1159/000351897. Epub 2015 Nov 24.'}, {'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': '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': '17465647', 'type': 'BACKGROUND', 'citation': 'Fischer TJ. Orthodontic treatment acceleration with corticotomy-assisted exposure of palatally impacted canines. Angle Orthod. 2007 May;77(3):417-20. doi: 10.2319/0003-3219(2007)077[0417:OTAWCE]2.0.CO;2.'}, {'pmid': '24592904', 'type': 'BACKGROUND', 'citation': 'Leethanakul C, Kanokkulchai S, Pongpanich S, Leepong N, Charoemratrote C. Interseptal bone reduction on the rate of maxillary canine retraction. Angle Orthod. 2014 Sep;84(5):839-45. doi: 10.2319/100613-737.1. Epub 2014 Mar 4.'}, {'pmid': '24182579', 'type': 'BACKGROUND', 'citation': 'Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.'}, {'pmid': '13793201', 'type': 'BACKGROUND', 'citation': 'AMLER MH, JOHNSON PL, SALMAN I. Histological and histochemical investigation of human alveolar socket healing in undisturbed extraction wounds. J Am Dent Assoc. 1960 Jul;61:32-44. doi: 10.14219/jada.archive.1960.0152. No abstract available.'}, {'pmid': '25329505', 'type': 'BACKGROUND', 'citation': 'Arreghini A, Lombardo L, Mollica F, Siciliani G. Torque expression capacity of 0.018 and 0.022 bracket slots by changing archwire material and cross section. Prog Orthod. 2014 Sep 25;15(1):53. doi: 10.1186/s40510-014-0053-x.'}, {'pmid': '23376899', 'type': 'BACKGROUND', 'citation': 'Pandis N, Walsh T, Polychronopoulou A, Katsaros C, Eliades T. Split-mouth designs in orthodontics: an overview with applications to orthodontic clinical trials. Eur J Orthod. 2013 Dec;35(6):783-9. doi: 10.1093/ejo/cjs108. Epub 2013 Feb 1.'}, {'type': 'BACKGROUND', 'citation': 'Alikhani M, Alansari S, Sangsuwon C, et al. Micro-osteoperforations: Minimally invasive accelerated tooth movement. Semin Orthod. 2015; 21(3): 162-169.'}]}, 'descriptionModule': {'briefSummary': 'Corticotomy and micro-osteoperforation (MOP) have been proven to accelerate tooth movement and shorten orthodontic treatment time, compared to conventional treatment. MOP is less invasive; however, it is unclear whether it is as effective as a corticotomy. The purpose of this study was to compare the maxillary canine retraction achieved by these techniques.', 'detailedDescription': 'Thirteen patients (5 females, 8 males; mean age, 18.07±6.74 years) with healthy permanent dentition requiring the extraction of maxillary first premolars were included in a split-mouth randomized clinical trial. Subjects with previous orthodontic or endodontic treatment of canines were excluded. At least 3 months post-extraction, MOPs, and corticotomies were performed distal to the canines. Mini-screws with closed-coil springs (150g) were used for canine retraction. Dental casts were attained at baseline (T0) and 3 months post-intervention (T1). Calibrated examiners measured the distances from the canine to the second premolar on both sides. A Signed-rank sum test was used to compare canine retraction achieved in 3 months (T0-T1) in two sides'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy permanent dentition requiring the extraction of maxillary first premolars with less than 8mm of maxillary anterior crowding\n\nExclusion Criteria:\n\n* Previous orthodontic or endodontic treatment of the canines'}, 'identificationModule': {'nctId': 'NCT04999150', 'briefTitle': 'Comparison of Corticotomy and Micro-Osteoperforation During Canine Retraction', 'organization': {'class': 'OTHER', 'fullName': 'University of Puerto Rico'}, 'officialTitle': 'A Split-Mouth Randomized Clinical Trial for the Comparison of Corticotomy and Micro-Osteoperforations During Canine Retraction: A Pilot Study', 'orgStudyIdInfo': {'id': 'UPR MSC IRB B0710118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Corticotomy', 'description': '1. A full-thickness labial mucoperiosteal flap was reflected.\n2. Two vertical corticotomies (1 mesial and 1 distal to the canine) were performed . The cortical bone was cut 2 to 3 mm below the alveolar crest towards the apex until bone marrow was exposed.\n3. Cortical-cancellous bone grafts (0.5cc; PuraGraft, Kingwood, TX) were placed at the corticotomy sites.\n4. The mini-screws were placed.\n5. A nickel-titanium (NiTi) closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge (Orthopli Corp., Philadelphia, PA) was used to measure the force (150g).', 'interventionNames': ['Procedure: Corticotomy']}, {'type': 'EXPERIMENTAL', 'label': 'Micro-Osteoperforation', 'description': '1. MOPs were performed with a stainless-steel manual drill tip that had 1.6mm diameter with an adjustable depth set to 5mm (Excellerator® RT; Propel Orthodontics, Milpitas, CA).\n2. Six perforations were made along 2 parallel vertical lines (each line with 3 holes spaced \\~2mm apart) distal to the canine and perpendicular to the buccal cortical bone.\n3. The mini-screws were placed.\n4. A NiTi closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge was used to measure the force (150g).', 'interventionNames': ['Procedure: Micro-Osteoperforations']}], 'interventions': [{'name': 'Micro-Osteoperforations', 'type': 'PROCEDURE', 'otherNames': ['MOP'], 'description': 'MOPs were performed with a stainless-steel manual drill tip that had 1.6mm diameter with an adjustable depth set to 5mm (Excellerator® RT; Propel Orthodontics, Milpitas, CA).\n\nSix perforations were made along 2 parallel vertical lines (each line with 3 holes spaced \\~2mm apart) distal to the canine and perpendicular to the buccal cortical bone.\n\nThe mini-screws were placed. A NiTi closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge was used to measure the force (150g)', 'armGroupLabels': ['Micro-Osteoperforation']}, {'name': 'Corticotomy', 'type': 'PROCEDURE', 'description': 'A full-thickness labial mucoperiosteal flap was reflected. Two vertical corticotomies (1 mesial and 1 distal to the canine) were performed. The cortical bone was cut 2 to 3 mm below the alveolar crest towards the apex, until bone marrow was exposed.\n\nCortical-cancellous bone grafts (0.5cc; PuraGraft, Kingwood, TX) were placed at the corticotomy sites.\n\nThe mini-screws were placed. A nickel-titanium (NiTi) closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge (Orthopli Corp., Philadelphia, PA) was used to measure the force (150g)', 'armGroupLabels': ['Corticotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00921', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'UPR Medical Sciences Campus', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Augusto R Elias, DMD,MSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assitant Dean of Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Puerto Rico', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Zagreb', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}