Clinical Trial Protocol Iranian Registry of Clinical Trials

01 Oct 2021

Eﬀect of micro-osteoperforations on the rate of tooth movement in the maxilliary and mandibular arches in human.

Protocol summary Registrant information Name Summary Dana Zandian Introduction: one of the general mutual problems Name of organization / entity besetting both patients and the orthodontist is the long Islamic Azad University, Isfahan (Khorasgan) Branch period of time required for orthodontic treatment. It is Country generally believed that the main limiting factor in the Iran (Islamic Republic of) movement of teeth is the cortical plate; hence by decline Phone this factor the duration of orthodontic treatment can be +98 61 3338 6675 Email address decreased. In recent years, a different method of flapless [email protected] corticotomy called micro-osteoperforations (MOP) has been introduced. Objective: The main aim of the study is Recruitment status the evaluation of MOP with two holes in the buccal Recruitment complete cortex, by presenting a on the rate of tooth movement. Funding source Also a comparison between the response of tooth Islamic Azad University, Isfahan (Khorasgan) Branch movement following MOP in the maxilla and the mandible has been done. Methods and Materials: each Expected recruitment start date side of jaws of ten class 1 dental malocclusion adults 2015-03-20, 1393/12/29 patients required extraction of the four first premolars Expected recruitment end date were divided into case and control group randomly. The 2016-07-19, 1395/04/29 experimental group of maxilla and mandible received Actual recruitment start date MOP with two holes using a bone screw and a hand held empty screwdriver .After 28 days, the rate of space closure Actual recruitment end date between canine and second premolar was measured empty through digital models in Ortho Analyser software. Trial completion date empty

General information Scientiﬁc title Eﬀect of micro-osteoperforations on the rate of tooth Acronym movement in the maxilliary and mandibular arches in MOP(micro-osteoperforation) human. IRCT registration information IRCT registration number: IRCT2016052127990N1 Public title Registration date: 2017-03-05, 1395/12/15 Orthodontic rate of tooth movement Registration timing: retrospective Purpose Treatment Inclusion/Exclusion criteria Last update: Inclusion criteria: Cl I malocclusion; no systemic disease; Update count: 0 no radio graphic bone loss; no active periodontal Registration date disease; no smoking; P.D <4mm. Exclusion criteria: 2017-03-05, 1395/12/15 history of medication; poor oral hygiene; Cl II,III

1 malocclusion; skeletal problem; cross bite; systemic 1 disorders; radio graphic bone loss; active periodontal Description disease; smoking; para-function; p.d>4mm. Rate of tooth movement Age Timepoint From 18 years old to 33 years old At the beginning of the intervention and 28 days later Gender Method of measurement Both Ortho Analyzer software Phase N/A Secondary outcomes Groups that have been masked empty No information Sample size Intervention groups Target sample size: 40 Randomization (investigator's opinion) Randomized 1 Randomization description Description Blinding (investigator's opinion) Intervention group: Micro-osteoperforation Single blinded Category Blinding description Treatment - Surgery Placebo Not used 2 Assignment Parallel Description Other design features Control: no intervention Category N/A Secondary Ids empty Recruitment centers

Ethics committees 1 Recruitment center 1 Name of recruitment center Islamic Azad University(Khorasgan branch), Ethics committee Orthodontic department Name of ethics committee Full name of responsible person Isfahan University of Medical Sciences Dr. Dana Zandian Street address Street address Isfahan University of Medical Sciences, Hezar Jarib City City Isfahan Isfahan Postal code Approval date Sponsors / Funding sources 2015-10-25, 1394/08/03 Ethics committee reference number 1 IR.MUI.REC.1394.4.95 Sponsor Name of organization / entity Health conditions studied Research Center of Dental Faculty Full name of responsible person Vahid Esfahanian 1 Street address Description of health condition studied Dental school, Isfahan Azad University (khorasegan tooth movement branch), Arghavanieh blvd. ICD-10 code City Z46.4 Isfahan ICD-10 code description Grant name Grant code / Reference number Fitting and adjustment of orthodontic device Is the source of funding the same sponsor organization/entity? Primary outcomes Yes

2 Title of funding source Islamic Azad University Isfahan(Khorasgan branch), Research Center of Dental Faculty Arghavanieh blvd. Proportion provided by this source City 100 Isfahan Public or private sector Postal code empty Phone Domestic or foreign origin +98 31 3535 4001 empty Fax Category of foreign source of funding Email empty [email protected] Country of origin Web page address Type of organization providing the funding Person responsible for updating data empty Contact Person responsible for general inquiries Name of organization / entity Islamic Azad University Isfahan(Khorasgan branch) Contact Full name of responsible person Name of organization / entity Dr. Dana Zandian Islamic Azad University Isfahan(Khorasgan branch) Position Full name of responsible person Resident of orthodontics Dr. Dana Zandian Other areas of specialty/work Position Street address Resident of orthodontics Islamic Azad University Isfahan(Khorasgan branch), Other areas of specialty/work Arghavanieh blvd. Street address City Islamic Azad University Isfahan(Khorasgan branch), Isfahan Arghavanieh blvd. Postal code City Phone Isfahan +98 31 3535 4001 Postal code Fax Phone Email +98 31 3535 4001 Web page address Fax Email [email protected] Sharing plan Web page address Deidentiﬁed Individual Participant Data Set (IPD) empty Person responsible for scientiﬁc Study Protocol inquiries empty Statistical Analysis Plan Contact empty Name of organization / entity Informed Consent Form Islamic Azad University Isfahan(Khorasgan branch) empty Full name of responsible person Clinical Study Report Dr. Masoud Feizbakhsh empty Position Analytic Code Assistant professor empty Other areas of specialty/work Data Dictionary Street address empty