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IRCT20221218056853N1 IRCT 2022-12-26 Tabriz University of Medical Sciences Laser therapy in lower lip paresthesia and dysesthesia LLLT Evaluation of the adjunctive effect of photobiomodulation therapy with Nd: YAG laser(1064nm) on decrease of lower lip paresthesia and dysesthesia in patients with inferior alveolar nerve damage 2022-12-22 anticipated 50 Complete https://irct.ir/trial/67488 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is simple and its unit is individual. The randomization tool will be a table of random numbers. Based on this, the type of intervention will be marked with code A (real laser therapy) and code B (placebo) and will be placed inside sealed envelopes. Then the envelopes will be placed in a bag and mixed. The envelopes will be randomly taken out of the bag and will be presented to the relevant intervention patients by observing the intervention code. None of the patients will be informed about the intervention of another patient, Blinding description: In this study, it will be explained to the patients that there is a possibility of their placement in the real or fake laser therapy group, but the patients will not know their group and the laser device will be used in both groups. Patients wear blindfolds during laser therapy to protect them from laser radiation and do not notice the real or fake laser therapy. Laser therapy is performed by a person who has no knowledge of real or fake laser therapy (only the aiming beam is turned on) and evaluates the results of the study in each session. Data analysis will also be done by a person who does not know about the groups. N/A Lower lip paresthesia and/or dysesthesia. Intervention 1: First Intervention group: Patients with paresthesia and dysesthesia of the lower lip with less than 6 months of injury who receive routine treatment plus low level laser therapy. Intervention 2: First Control group: Patients with paresthesia and dysesthesia of the lower lip less than 6 months after the injury, who receive routine treatment plus placebo. Intervention 3: Second Intervention group: Patients with paresthesia and dysesthesia of the lower lip with more than 6 months of injury who receive routine treatment plus low level laser therapy. Intervention 4: Second Control group: Patients with paresthesia and dysesthesia of the lower lip more than 6 months after the injury, who receive routine treatment plus placebo. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: The access period starts from 2023 To whom: All people can apply for study documents. Conditions: The data of this study can be used to investigate the effect of low level laser therapy in patients who only have paresthesia or dysesthesia of the lower lip. Where to obtain: Meghdad Eslami 0098 9148528993 How to obtain: After submitting the application, the study documentation file will be sent as soon as possible Comments:
public Meghdad Eslami
No.346, 2th Golestan Ave, Ostandari Blvd
Tabriz Iran (Islamic Republic of) 5158943846 +98 41 3660 9691 meghdadeslami72@gmail.com Tabriz University of Medical Sciences scientific Meghdad Eslami
No.346, 2th Golestan Ave, Ostandari Blvd
Tabriz Iran (Islamic Republic of) 5158943846 +98 41 3660 9691 meghdadeslami72@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Paresthesia and dysesthesia of the lower lip, which are classified as 1, 2, and 3 in the Sunderland classification Not performing previous intervention related to nerve damage no limit no limit Both The presence of mass in the face, jaw and neck area Active infection in the chin and jaw area Involvement of other branches of the trigeminal nerve except the inferior alveolar nerve R20.2 Paresthesia of skin Treatment - Other Treatment - Other Treatment - Other Treatment - Other First Intervention group: Patients with paresthesia and dysesthesia of the lower lip with less than 6 months of injury who receive routine treatment plus low level laser therapy. First Control group: Patients with paresthesia and dysesthesia of the lower lip less than 6 months after the injury, who receive routine treatment plus placebo. Second Intervention group: Patients with paresthesia and dysesthesia of the lower lip with more than 6 months of injury who receive routine treatment plus low level laser therapy. Second Control group: Patients with paresthesia and dysesthesia of the lower lip more than 6 months after the injury, who receive routine treatment plus placebo. Visual analogue scale (VAS). Timepoint: Before starting the intervention and in every 10 laser therapy sessions. Method of measurement: In this way, Scale = 0 is considered for lack of sensitivity and Scale = 10 is considered as normal sensitivity and the patient is asked to choose a number between 0 and 10. Two-point discrimination test. Timepoint: Before starting the intervention and in every 10 laser therapy sessions. Method of measurement: Static two-point discrimination test is performed by two objects on the skin, which can be used to measure the distance between two points. These objects should be blunt and non-sharp and have the ability to stimulate pain receptors. The closest distance that the patient can distinguish two points from one point is recorded. Tabriz University of Medical Sciences Approved 2022-12-04 Ethics Committee of Tabriz University of Medical Sciences Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Tabriz East Azarbaijan Iran (Islamic Republic of)