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IRCT20190511043559N1 IRCT 2019-09-13 Kerman University of Medical Sciences Laser effect on orthodontics relapse Evaluation of low level laser therapy in relapse of rotated premolar teeth in patients under fixed orthodontics treatment 2019-03-06 anticipated 24 Complete https://irct.ir/trial/40366 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization is performed in which individuals are divided into two groups of intervention and control based on random numbers. N/A Relapse of rotated premolar teeth in patients under fixed orthodontics treatment. Intervention 1: Intervention group: One of the patient's rotated premolar will be irradiated with low-level Indium Aluminum Arsenide diode laser (Epic10, Biolase USA, wavelength 940 nm) 2 times a week for 4 weeks with a density of 35.7 J/cm2. Laser probe with the power of 500 milliwatt contacts the gingival tissue of one-third coronal root surface. This irradiation is applied on 2 points around the tooth including the lingual and buccal side. Irradiation continues for 120 seconds on each point. The final archwire will be removed and the alginate impression will be taken and poured with dental stone. casts will be scanned with a scanner (DentalDirekt DD Argus M2 UHD) (T1). Then archwire will be removed for 6 weeks from the rotated teeth to let the teeth relapsing. After 6 weeks the second impression will be taken and casts will be poured and scanned (T2). After that casts will be analyzed using Digimizer software for measuring dental relapse. Intervention 2: Control group: Another rotated premolar of the patient falls in the control group which will not get any laser irradiation. After completion of the intervention group's laser therapy, alginate impression will be taken and final archwire will be removed for 6 months to let the teeth relapsing. After 6 months, the alginate impression is taken again and casts are prepared. afterwards casts will be analysed using Digimizer software for the magnitude of relapse. Yes - There is a plan to make this available What will be shared: Data can be shared after patients are made unrecognizable. When: Commence of accessibility will be one month after results publishment. To whom: َAll individuals can send requests to access data. Conditions: There are no conditions for access to the results. Where to obtain: Contact us Fatemeh Abdi abdi_201339@yahoo.com How to obtain: The results will be sent after receiving a request of need for this study within a week. Comments:
public Fatemeh Abdi
Orthodontics Depatment, Kerman Dental School, Shafa Ave, Kerman Town
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9021 abdi_201339@yahoo.com Kerman University of Medical Sciences scientific Neda Sinaee
Orthodontics Department, Kerman Dental School, Shafa Ave, Kerman Town
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9021 nedasinaee@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Patients with full permanent dentition under orthodontics treatment with at least two rotated premolar teeth of 30 degrees rotation on both side of upper or both side of lower arch Dental rotation should have been corrected Patient with no pre-extracted or missing teeth Patient should not have extracted teeth for orthodontic purpose Patients of 12 years old or over 12 years no limit Both Pregnancy Patients with systemic diseases Patients with periodontal disease and poor oral hygiene Teeth with severe caries and restorations extended to CEJ Taking medications that interfere with bone metabolism Z00-Z99 Factors influencing health status and contact with health services Prevention Prevention Intervention group: One of the patient's rotated premolar will be irradiated with low-level Indium Aluminum Arsenide diode laser (Epic10, Biolase USA, wavelength 940 nm) 2 times a week for 4 weeks with a density of 35.7 J/cm2. Laser probe with the power of 500 milliwatt contacts the gingival tissue of one-third coronal root surface. This irradiation is applied on 2 points around the tooth including the lingual and buccal side. Irradiation continues for 120 seconds on each point. The final archwire will be removed and the alginate impression will be taken and poured with dental stone. casts will be scanned with a scanner (DentalDirekt DD Argus M2 UHD) (T1). Then archwire will be removed for 6 weeks from the rotated teeth to let the teeth relapsing. After 6 weeks the second impression will be taken and casts will be poured and scanned (T2). After that casts will be analyzed using Digimizer software for measuring dental relapse. Control group: Another rotated premolar of the patient falls in the control group which will not get any laser irradiation. After completion of the intervention group's laser therapy, alginate impression will be taken and final archwire will be removed for 6 months to let the teeth relapsing. After 6 months, the alginate impression is taken again and casts are prepared. afterwards casts will be analysed using Digimizer software for the magnitude of relapse. Dental relapse. Timepoint: At the end of study. Method of measurement: Digimizer software. Rotation of premolar tooth. Timepoint: Before orthodontics treatment. Method of measurement: Digimizer software. Time duration after correction of tooth rotation. Timepoint: At the start of study. Method of measurement: Month numbers. Kerman University of Medical Sciences Approved 2019-07-30 Ethics committee of Kerman University of Medical Sciences Orthodontics Depatment, Kerman Dental School, Shafa Ave, Kerman Town Kerman Kerman Iran (Islamic Republic of)