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IRCT20210221050435N1 IRCT 2021-04-04 Yazd University of Medical Sciences The effect of low level laser on mandibular growth in patients treated with functional appliance Evaluation of the effect of low level laser in the treatment of class II patients with mandibular deficiency treated with Farmand functional appliance 2021-03-05 anticipated 22 Complete https://irct.ir/trial/54505 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, using Random allocation software version 1.0 under Windows ,we generate a random sequence using a simple random allocation method. In this table, it is specified from 1 to 22 and each number is assigned to an intervention group (A or B). The first eligible patient is assigned number 1, the second patient is assigned number 2 and so on up to 22 patients. In order to blind the random allocation of clients by a third person who is unaware of the interventions, they are placed in intervention groups (A or B) by this table, Blinding description: In our study, patients are unaware of which group they are in (Farmand group or Farmand + laser group) because all patients, even those who does not include laser receiving, are in the same situation to receive the laser, except that we placed the applicator of laser in specific places, but without laser radiation. In this study, with the exception of the laser device operator (who is aware of the laser irradiation or non-irradiation), the researcher (who is also responsible for treating the patients), the data collector, and the statistics consultant, who is responsible for analyzing the data, all are unaware of which group each patient belonged to. N/A mandibular deficiency. Intervention 1: Intervention group: After the Farmand functional appliances are made for each patient, they are trained to use the appliance 24 hours a day, except when eating, exercising, and brushing. The laser used in this study is diode (GaA1As) (A.R.C. Laser, Deutschland, Nurberg) with a wavelength of 980 nm, the output power of 100 mw. After one month of using the appliance, until the end of treatment, once a week (12 sessions) laser with the above characteristics is irradiated. Radiation is performed accurately and continuously by contact method at 4 points around the temporomandibular joint (upper, anterior, posterior, posterior) and 100 seconds for each point. Intervention 2: Control group: We place the patients in control group in the same conditions (constructing a functional appliance, training for use, starting treatment with a functional appliance and presence at laser treatment sessions) with the difference that we place only the laser applicator in the mentioned points but without laser radiation. Yes - There is a plan to make this available What will be shared: after unidentifying, It is possible to share all lateral cephalometric variables of patients before and after treatment. When: Start the access period 6 months after publishing the results To whom: Researchers working in academic and scientific institutions and valid scientific research journals Conditions: In order to use the documents of this study for other studies and researches to apply the results Where to obtain: Responsible person in this field: Mohadeseh Sharifi , email address: Sharifimohadeseh@yahoo.com How to obtain: The applicant can send his request to the above-mentioned email address with his introduction and the reason for the request and receive the information as soon as possible (finally within 7-10 days). Comments:
public Hossein agha Aghili
Dental school, The beginning of Dahe Fajr Boulevard, Imam Khomeini St, Yazd
Yazd Iran (Islamic Republic of) 8914881167 +98 35 3625 5881 hosseinaghily@gmail.com Yazd University of Medical Sciences scientific Hossein Aghili
Shahid sadoughi university of medical sciences .school of dentistry.orthodontics dept
Yazd Iran (Islamic Republic of) 8914881167 +98 35 3824 1785 Hosseinaghily@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Age range 10 to 13 years for girls and 11 to 14 years for boys The patient profile in clinical view show the pattern of skeletal class II with mandibular deficiency so that the patient with retrognathic appearance has more acceptance profile after bringing the mandible forward. The patient has dental canine and molar class II relationship 10 years 14 years Both History of disease affected the growth process History of jaw surgery History of trauma to skull and face M27.0 Developmental disorders of jaws Treatment - Devices Treatment - Devices Intervention group: After the Farmand functional appliances are made for each patient, they are trained to use the appliance 24 hours a day, except when eating, exercising, and brushing. The laser used in this study is diode (GaA1As) (A.R.C. Laser, Deutschland, Nurberg) with a wavelength of 980 nm, the output power of 100 mw. After one month of using the appliance, until the end of treatment, once a week (12 sessions) laser with the above characteristics is irradiated. Radiation is performed accurately and continuously by contact method at 4 points around the temporomandibular joint (upper, anterior, posterior, posterior) and 100 seconds for each point. Control group: We place the patients in control group in the same conditions (constructing a functional appliance, training for use, starting treatment with a functional appliance and presence at laser treatment sessions) with the difference that we place only the laser applicator in the mentioned points but without laser radiation. Increase rate of Co-Gn variable. Timepoint: Measurement of Co-Gn variable at the beginning of study (before the start of intervention) and after the end of functional appliance treatment period (after 6 months). Method of measurement: Measurement on lateral cephalometric radiographs using a ruler and conveyor. Increase rate of ANB variable. Timepoint: Measurement of ANB variable at the beginning of study (before the start of intervention) and after the end of functional appliance treatment period (after 6 months). Method of measurement: Measurement on lateral cephalometric radiographs using a ruler and conveyor. Yazd University of Medical Sciences Approved 2019-05-25 Ethic committee of Yazd Shahid sadoughi University of medical science central building of shahid sadoughi university of medical science and health services-Bahonar square-Yazd Yazd Yazd Iran (Islamic Republic of)