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IRCT20220108053669N3 IRCT 2023-03-01 Mashhad University of Medical Sciences Comparison of a new method of placing orthodontic brackets (devices) with the standard method in terms of effects on smile beauty and dental inclinations and values Comparison of a new method of placing orthodontic brackets (devices) with the standard method in terms of effects on smile beauty and dental inclinations and values 2023-01-21 anticipated 40 Complete https://irct.ir/trial/65944 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Patients will be divided into two group of 20 people using four strata using stratified randomization. IOn this way, according to the two confounding variables of age and gendr, in terms of gender, male and female, and in terms of age, in two groups of less than 15 yearts, and 15 years and older, four strata will be obtained and with random allocation of the members of each stratum will be placed in one of two intervention or control groups with the help of a random number table, Blinding description: In this study, due to the nature of the intervention, it is not possible to blind the clinician (orthodontist who places the brackets) to the method of placing the brackets. However, despite the knowledge of participating in the study, the patients will not know the method of placing the brackets, and in general, it is not possible to distiniguish the method of bracketing by pateints and non-spe3cialists. In addiction, the individuals and the panel that measure and evaluate the outcomes of the study and the statistician will be blinded to the type of treatment received by the patients. 3 Orthosurgery. Intervention 1: Intervention group: in 20 people who will be randomly placed in the intervention group; Roth 018 orthodontic brackets will be placed on the front teeth with the smile arc protection method. In such a way that the incisal edge of the wings of the canine bracket, will be placed gingival to the hypothetical line connecting the mesial and distal contacts of this tooth. The central bracket is placed 1.5 mm more gingivally than the distance from the incisal edge to the canine bracket slot. The lateral bracket will be bonded 0.75 to 1 mm more incisal than the central bracket. In the posterior teeth of patients in the intervention group, as in the control group, the center of the bracket slot will be placed on the LA point and in line with the longitudinal axis of the tooth. Intervention 2: Control group: in 20 patients who will be randomly placed in the control group; Roth 018 orthodontic brackets, in the front teeth will be placed in the usual and standard way (i.e. the center of the bracket slot with a distance of 4.5, 4 and 4.5 mm from the incisal edge, respectively, for central, lateral and canine in children and with a distance of 5, 4.5 and 5 mm from the incisal edge respectively for central, lateral and canine in adults) and in posterior teeth, the center of the bracket slot will be placed on the LA point and in line with the longitudinal axis of the tooth. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Alireza Ghasemzadeh
Faculty of Dentistry, In front of Mellat park, Vakil Abad Boulvard, Mashhad.
Mashhad Iran (Islamic Republic of) ٩١٧٧٩۴٨٩۵٩ +98 51 3841 1538 GhayourM@mums.ac.ir Mashhad University of Medical Sciences scientific Alireza Ghasemzadeh
Faculty of Dentistry, In front of Mellat park, Vakil Abad Boulvard, Mashhad.
Mashhad Iran (Islamic Republic of) ٩١٧٧٩۴٨٩۵٩ +98 51 3841 1538 GhayourM@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Receiving comprehensive orthodontic treatment by patients Good oral hygiene and proper patient cooperation No need for tooth extraction in the treatment plan Absence of severe deep bite in patients 11 years 25 years Both Patients in need of orthosurgery and cosmetic surgeries Receiving expansion by patients Patients who need to change the shape of their teeth after orthodontic treatment Treatment - Other Treatment - Other Intervention group: in 20 people who will be randomly placed in the intervention group; Roth 018 orthodontic brackets will be placed on the front teeth with the smile arc protection method. In such a way that the incisal edge of the wings of the canine bracket, will be placed gingival to the hypothetical line connecting the mesial and distal contacts of this tooth. The central bracket is placed 1.5 mm more gingivally than the distance from the incisal edge to the canine bracket slot. The lateral bracket will be bonded 0.75 to 1 mm more incisal than the central bracket. In the posterior teeth of patients in the intervention group, as in the control group, the center of the bracket slot will be placed on the LA point and in line with the longitudinal axis of the tooth. Control group: in 20 patients who will be randomly placed in the control group; Roth 018 orthodontic brackets, in the front teeth will be placed in the usual and standard way (i.e. the center of the bracket slot with a distance of 4.5, 4 and 4.5 mm from the incisal edge, respectively, for central, lateral and canine in children and with a distance of 5, 4.5 and 5 mm from the incisal edge respectively for central, lateral and canine in adults) and in posterior teeth, the center of the bracket slot will be placed on the LA point and in line with the longitudinal axis of the tooth. Amount of incisor display at smile. Timepoint: Measuring the amount of incisor display at smile 1- before starting orthodontic treatment 2- after completing orthodontic treatment. Method of measurement: With the help of a gauge or caliper in millimeters. Additionally, the smile line or lip line index, which indicates the visibility of the upper incisors and the raising of the upper lip during a smile, and divides patients into high, average, and low categories; will be used. While smiling in the high type, the front teeth of the maxilla are seen with a significant amount of gum. In average type, maxillary anterior teeth along with only interdental gum and in low type, less than two thirds of maxillary anterior teeth are visible during smile. Smile arc. Timepoint: Determining the type of smile arc at 1- before starting orthodontic treatment 2- after completing orthodontic treatment. Method of measurement: The smile arc will be placed visually by the evaluator in one of three categories: consonant (harmony of the curvature of the upper front teeth with the arch of the lower lip), non-consonant (including flat and reverse) and not-available (in cases where the front of the maxilla is covered by the lower lip). Labiodental relationship of the lower lip and maxillary anterior teeth. Timepoint: Determining the labiodental relationship of the lower lip and maxillary anterior teeth at 1- before starting orthodontic treatment 2- after completing orthodontic treatment. Method of measurement: It was identified by evaluating the distance between the superior border of the lower lip and inferior border of the maxillary anterior teeth. The relationship may be divided into lower lip “slightly touching” the lower border of maxillary anterior teeth, “not touching” the teeth or “covering” the anterior teeth. Overbite measurement in millimeters. Timepoint: Measuring the amount of overbite 1- before starting orthodontic treatment 2- after completing orthodontic treatment. Method of measurement: with the help of a gauge or caliper in millimeters by assessor from study models. Axial inclination of upper anterior teeth (U1 to SN and U1 to NA). Timepoint: Measuring the axial inclination of upper anterior teeth 1- before starting orthodontic treatment 2- after completing orthodontic treatment. Method of measurement: measured by Dolphin software version 11 after lateral cephologram tracing. Measurement of occlusal plane angle. Timepoint: Measuring the occlusal plane angle 1- before starting orthodontic treatment 2- after completing orthodontic treatment. Method of measurement: measured by Dolphin software version 11 after lateral cephologram tracing. Perceived smile esthetics. Timepoint: Measuring the perceived smile esthetics 1- after completing orthodontic treatment. Method of measurement: frontal and close-up photograph of all patients' smiles at the end of the treatment will be given to a panel of 30 persons, including ten orthodontists, ten general dentists, and ten lay persons, and they will be asked to give their opinion about the beauty of the smiles of the treated patients in two treatment and intervention groups, by scoring their smile based on a visual analogue scale. Mashhad University of Medical Sciences Approved 2022-06-26 Mashhad University of Medical Sciences Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)