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IRCT20200111046078N1 IRCT 2020-03-22 Mashhad University of Medical Sciences Comparison of direct and indirect methods in retraction of maxillary anterior teeth by mini-screw in orthodontic patients: A randomized clinical trial. Comparison of direct and indirect methods in retraction of maxillary anterior teeth by mini-screw in orthodontic patients: A randomized clinical trial. 2019-04-05 anticipated 24 Complete https://irct.ir/trial/44910 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization models such as lane or line, random number table or computer randomization methods will be used. And we will put every client in the intervention or control group, for example by dropping coins, lane , and lines, Blinding description: Since both groups of patients are treated the same way, and the only difference between the two groups is in mechanical therapy, it is natural that patients are not aware of the type of mechanical therapy. Since the statistical data is provided to the statistical adviser without specifying the group name, it is obvious that the statistical advisor is not aware of the groups. N/A Malocclusion, Angle class II. Intervention 1: Intervention group: Intervention group 1: direct en mass retraction: The treatment plan for all patients in both groups will include maxillary first premolar extraction on both sides. After the pre-treatment records (lateral cephalometry and cast) were taken from the patients, Roth system brackets (0.018×0.028 ) will be bandaged for all patients. Lateral cephalometry and Oral Scan will be provided for all patients after leveling and alignment. Then the miniscrews (8 mm 4 1.4 mm in diameter of the bracket type, Jeil ؛ Dentos, Daegu, South Korea) will be anesthetized on the buccal side of the interstitial bone in the gingiva attachment between the second premolar and the first molar. (33). The retraction in both groups will continue until the Cl I canonical relationship and the Insisurian relationship are achieved. After closure of the extraction space, all patients in both cephalometric and Oral Scan radiographs will again be taken to evaluate the variables (33 and 20). Arch wires stainless steel (0.016 02 0.02) with crimpable hooks in distal lateral incisor in maxilla, and 150 g force on each side with a nickel titanium coil spring closed from implant to crimpable hooks Expanded in parallel with occlusal planes applied for en-mass retraction of maxillary anterior teeth. En-mass retraction will be performed after 3 weeks of miniscrew placement (due to lack of rapid force loading and failure of miniscrew). Coil springs are checked for strength every 3 weeks. After the Leveling & Alignment phase, all patients will receive lateral cephalometry and Oral Scan. The retraction continues until the Cl I canonical relationship and the insisural relationship are achieved. After the closure of the extraction space, all patients will be re-taken with cephalometric radiography and Oral Scan to evaluate the variables. Intervention 2: Intervention group: Intervention group 2: indirect en mass retraction: The treatment plan for all patients in both groups will include maxillary first premolar extraction on both sides. After the pre-treatment records (lateral cephalometry and cast) were taken from the patients, Roth system brackets (0.018×0.028 ) will be bandaged for all patients. Lateral cephalometry and Oral Scan will be provided for all patients after leveling and alignment. Then the miniscrews (8 mm 4 1.4 mm in diameter of the bracket type, Jeil ؛ Dentos, Daegu, South Korea) will be anesthetized on the buccal side of the interstitial bone in the gingiva attachment between the second premolar and the first molar. (33). The retraction in both groups will continue until the Cl I canonical relationship and the Insisurian relationship are achieved. After closure of the extraction space, all patients in both cephalometric and Oral Scan radiographs will again be taken to evaluate the variables (33 and 20). In the indirect method, the mini-screws will passively attach to the first molars using a 0.016 × 0.02 02 0.02 stainless steel auxiliary wire, which provides the indirect anchorage. En-mass retraction after 3 weeks of miniscrew placement (due to failure to load fast and failure of miniscrew) with a closed coil spring nickel titanium alloy (150 g force on each side) mounted to the hook between lateral and canine incisors Gets Started. After closure of the extraction space, cephalometric radiographs and Oral Scans will be taken from patients to evaluate variables. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mohammad Sadegh Nazari
Vakil Abad Blvd., School of Dentistry, Department of Orthodontics
Mashhad Iran (Islamic Republic of) 9177948959 +98 66 3313 3223 msn.dentist@yahoo.com Mashhad University of Medical Sciences scientific Mohammad Sadegh Nazari
Vakil Abad Blvd., School of Dentistry, Department of Orthodontics
Mashhad Iran (Islamic Republic of) 9177948959 +98 66 3313 3223 msn.dentist@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) 1- Having permanent teeth 2- Good oral hygine 3. Skeletal pattern of Cl I or Cl II 4- No transverse anomaly 5. No systemic disease that has contraindication for orthodontic treatment 6. Not having any systemic or allergic disease that is contraindicated for the use of the skeletal anchorage unit. 7. Remaining more than 4 mm of space in the distal canine after Alignment & Leveling. no limit no limit Both 1- Poor oral hygine 2- History of drug use 3. Systemic disease 4- Hormonal imbalance, Failed mini-screw. M26.212 Malocclusion, Angle's class II Treatment - Devices Treatment - Devices Intervention group: Intervention group 1: direct en mass retraction: The treatment plan for all patients in both groups will include maxillary first premolar extraction on both sides. After the pre-treatment records (lateral cephalometry and cast) were taken from the patients, Roth system brackets (0.018×0.028 ) will be bandaged for all patients. Lateral cephalometry and Oral Scan will be provided for all patients after leveling and alignment. Then the miniscrews (8 mm 4 1.4 mm in diameter of the bracket type, Jeil ؛ Dentos, Daegu, South Korea) will be anesthetized on the buccal side of the interstitial bone in the gingiva attachment between the second premolar and the first molar. (33). The retraction in both groups will continue until the Cl I canonical relationship and the Insisurian relationship are achieved. After closure of the extraction space, all patients in both cephalometric and Oral Scan radiographs will again be taken to evaluate the variables (33 and 20). Arch wires stainless steel (0.016 02 0.02) with crimpable hooks in distal lateral incisor in maxilla, and 150 g force on each side with a nickel titanium coil spring closed from implant to crimpable hooks Expanded in parallel with occlusal planes applied for en-mass retraction of maxillary anterior teeth. En-mass retraction will be performed after 3 weeks of miniscrew placement (due to lack of rapid force loading and failure of miniscrew). Coil springs are checked for strength every 3 weeks. After the Leveling & Alignment phase, all patients will receive lateral cephalometry and Oral Scan. The retraction continues until the Cl I canonical relationship and the insisural relationship are achieved. After the closure of the extraction space, all patients will be re-taken with cephalometric radiography and Oral Scan to evaluate the variables. Intervention group: Intervention group 2: indirect en mass retraction: The treatment plan for all patients in both groups will include maxillary first premolar extraction on both sides. After the pre-treatment records (lateral cephalometry and cast) were taken from the patients, Roth system brackets (0.018×0.028 ) will be bandaged for all patients. Lateral cephalometry and Oral Scan will be provided for all patients after leveling and alignment. Then the miniscrews (8 mm 4 1.4 mm in diameter of the bracket type, Jeil ؛ Dentos, Daegu, South Korea) will be anesthetized on the buccal side of the interstitial bone in the gingiva attachment between the second premolar and the first molar. (33). The retraction in both groups will continue until the Cl I canonical relationship and the Insisurian relationship are achieved. After closure of the extraction space, all patients in both cephalometric and Oral Scan radiographs will again be taken to evaluate the variables (33 and 20). In the indirect method, the mini-screws will passively attach to the first molars using a 0.016 × 0.02 02 0.02 stainless steel auxiliary wire, which provides the indirect anchorage. En-mass retraction after 3 weeks of miniscrew placement (due to failure to load fast and failure of miniscrew) with a closed coil spring nickel titanium alloy (150 g force on each side) mounted to the hook between lateral and canine incisors Gets Started. After closure of the extraction space, cephalometric radiographs and Oral Scans will be taken from patients to evaluate variables. Anchorage loss due to lateral cephalometric radiographics and oral scan. Timepoint: Lateral cephalometry at baseline (before treatment); oral scan after leveling & alignment; oral scan and lateral cephalometry after space closure. Method of measurement: Linear and angular measurements of variables from oinal scan and lateral cephalometry. Mashhad University of Medical Sciences Approved 2019-12-29 Ethics committee of Mashhad University of Medical Sciences Vakilabad Blvd., Mellat Park, Mashhad University of Medical Sciences, Faculty of Dentistry, Deputy of Research and Technology Mashhad Razavi Khorasan Iran (Islamic Republic of)