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IRCT20191008045028N1 IRCT 2019-12-11 Yazd University of Medical Sciences Effect of diode laser irradiation on pro-inflammatory cytokines and mini-screw stability Effect of 980 nm diode laser irradiation on pro-inflammatory cytokines and mini-screw stability 2019-05-22 anticipated 12 Complete https://irct.ir/trial/43051 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization is done.the side of laser irradiation and the control side is determined by the coin toss of each patient, Blinding description: Banding and bonding of teeth perform by the first examiner for all patients. Low level laser perform by the second examiner in a double-blind fashion such that the patient and the first examiner blind to the group allocation of each quadrant and the selected quadrant for laser therapy. 3 patients with class II division I malocclusion or bimaxillary protrusion. Intervention 1: Intervention group:Mini-screws were placed between the roots of maxillary second premolar and first molar. Diode laser was irradiated with 980 nm wavelength and 100 mW output power in continuous-wave mode for 30 seconds to the occlusal and 30 seconds to the gingival part of the mini-screw at four time points: T0 (1 h after mini-screw placement), T1 (1 week later), T2 (at 1 month) and T3 (at 3 months) in one quadrant of the maxilla (laser group). Intervention 2: Control group: Simultaneously the other quadrant of the maxilla underwent pseudo-application of laser . Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main outcome, can be shared. When: Start of access period 6 months after printing results To whom: Researchers working in academic and scientific institutions Conditions: To promote motivation and science Where to obtain: s.kordi3314@yahoo.com somaye kordi How to obtain: Email the responsible author Comments:
public Somaye Kordi
Department of Orthodontic, Faculty of Dentistry, Dahaye Fajr BLV, Imam Ave, Yazd, Iran
Yazd Iran (Islamic Republic of) 89195/165 +98 35 3621 2222 S.kordi3314@yahoo.com Yazd University of Medical Sciences scientific Somaye Kordi
Department of Orthodontic, Faculty of Dentistry, Dahaye Fajr BLV, Imam Ave, Yazd, Iran
Yazd Iran (Islamic Republic of) 89195/165 +98 35 3621 2222 S.kordi3314@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Patients with bimaxillary dentoalveolar protrusion or class II division I malocclusion requiring extraction of maxillary first premolars and anterior retraction. Good oral hygiene Signing the informed consent forms by the patients or their parents 15 years 18 years Both systemic disease history of extraction of other permanent teeth taking medications affecting the level of pro-inflammatory cytokines such as non-steroidal anti-inflammatory drugs and corticosteroids during the study period or in the past one month prior to the onset of treatment periodontal disease or radiographic evidence of bone loss pregnancy during the orthodontic treatment Treatment - Devices Placebo Intervention group:Mini-screws were placed between the roots of maxillary second premolar and first molar. Diode laser was irradiated with 980 nm wavelength and 100 mW output power in continuous-wave mode for 30 seconds to the occlusal and 30 seconds to the gingival part of the mini-screw at four time points: T0 (1 h after mini-screw placement), T1 (1 week later), T2 (at 1 month) and T3 (at 3 months) in one quadrant of the maxilla (laser group). Control group: Simultaneously the other quadrant of the maxilla underwent pseudo-application of laser . The primary stability of mini-screws. Timepoint: at four time points: T0 (1 h after mini-screw placement), T1 (1 week later), T2 (at 1 month) and T3 (at 3 months).PTV was measured at the above mentioned four time points and one hour after laser irradiation. Method of measurement: The primary stability of mini-screws was measured by Periotest M and reported as Periotest value (PTV). At each time point, samples were collected from the PMCF to assess the concentration of IL-1B and TGF-B1. Inflammation around the mini-screws. Timepoint: at four time points: T0 (1 h after mini-screw placement), T1 (1 week later), T2 (at 1 month) and T3 (at 3 months).The samples were collected at the aforementioned four time points and one hour after laser irradiation and prior to the measurement of PTV. Method of measurement: PMCF samples were collected using high-purity filter papers used as paper strips to measure the concentration of IL-1β and TGF-β1.A cotton roll was used for isolation of the area and the mini-screw site was dried with air spray for 15 seconds. The paper strip was inserted into the gingival sulcus around the mini-screw and remained there for 60 s. If the Periostrip was contaminated with blood or saliva, sampling was repeated. Immediately after PMCF collection, the paper strips were transferred into sterile 1.5 mL microtubes containing 250 µL of phosphate buffered saline. Parafilm (Bemis; Neenah, Wisconsin, USA) was used to seal the tubes. The vials were stored at -20°C until collection of all samples and onset of experiment. The PMCF samples were used to measure the concentration of IL-1β using a kit designed for this purpose (Diaclone SAS, Besancon, France) and TGF-β1 using the respective kit (IBL International GMBH, Germany) by enzyme-linked immunosorbent assay according to the manufacturers’ instructions. At each time point, samples were collected from the PMCF to assess the concentration of IL-1B and TGF-B1. Timepoint: at four time points: T0 (1 h after mini-screw placement), T1 (1 week later), T2 (at 1 month) and T3 (at 3 months). Method of measurement: The PMCF samples were used to measure the concentration of IL-1B using a kit designed for this purpose (Diaclone SAS, Besancon, France) and TGF-B1 using the respective kit (IBL International GMBH, Germany) by enzyme-linked immunosorbent assay according to the manufacturers’ instructions. Yazd University of Medical Sciences Approved 2018-05-30 Ethics committee of shahid sadoughi University of Medical Sciences Faculty of Dentistry, Dahaye Fajr BLV, Imam Ave, Yazd, Iran Yazd Yazd Iran (Islamic Republic of)