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IRCT20180114038364N1 IRCT 2020-05-02 Tabriz University of Medical Sciences effect of low level laser therapy on postoperative pain in gum surgery Effect of Low Level Laser Therapy on post operative pain after clinical crown lengthening procedures 2020-05-21 anticipated 30 Complete https://irct.ir/trial/47328 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomization will be individually and simple. using the table of randomized numbers, each individual will be put in either of the laser therapy or control groups. Odd numbers will be assigned to the intervention group and even numbers will be assigned to the control group. the analyst will move in a specific direction in the table in one row or column and assign the numbers to the patients. the surgeon and the researcher will not know the patient's group until the surgery is over. after the surgery, the researcher will know the individual's code number and if the code is an odd number then patient will be referred for low level laser therapy and if the code number is an even number, the patient will be referred for placebo laser therapy, Blinding description: This study is designed as one way blind and the patients will be blinded. all the participants in the study will be informed that they will receive low level laser therapy after the surgery so that the effect of laser on post operation pain is evaluated. same information and instructions will be given to all the patients regarding the laser therapy. in the laser therapy group, the laser is applied with a specific dose and specific duration and within a specific distance from the site of surgery. in the control group the same laser will be held for the same duration and same distance from the surgery site but the laser is not active and the patient will not be informed that the laser is not active. N/A post operative pain. Intervention 1: Intervention group: a diode GaAlAs laser with a power of 100 milliwatts, wave length of 660 nano meters and energy density of 4 jules per square centimetres will be used on the surgery site for a duration of 30 seconds. this will be done at the day of surgery, 3 days after surgery and 7 days after surgery. Intervention 2: Control group: a diode GaAlAs laser(same with the intervention group) will be used deactivated on the site of surgery for 30 seconds. this will be done at the day of surgery, 3 days after surgery and 7 days after surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is no further comments.
public Sina Ranjbaraghdam
no 96, 3rd hafez avenue, eil goli boulevard, Tabriz
Tabriz Iran (Islamic Republic of) 5166884461 +98 41 3383 1992 ranjbar.sinara.sina576@gmail.com Tabriz University of Medical Sciences scientific Sina Ranjbaraghdam
no 96, 3rd hafez avenue, eil goli boulevard, Tabriz
Tabriz Iran (Islamic Republic of) 5166884461 +98 41 3383 1992 ranjbar.sinara.sina576@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) the patients must be between 18 and 60 years of age patients must not have systemic conditions patients must have adequate oral hygiene 18 years 60 years Both if the patient is a smoker. if the patient has systemic conditions. if the patient has drug induced gum hyperplasia. G89.18 other acute post procedural pain Treatment - Devices Placebo Intervention group: a diode GaAlAs laser with a power of 100 milliwatts, wave length of 660 nano meters and energy density of 4 jules per square centimetres will be used on the surgery site for a duration of 30 seconds. this will be done at the day of surgery, 3 days after surgery and 7 days after surgery. Control group: a diode GaAlAs laser(same with the intervention group) will be used deactivated on the site of surgery for 30 seconds. this will be done at the day of surgery, 3 days after surgery and 7 days after surgery. The amount of post operative pain on a scale of 0 to 10. Timepoint: Daily up to 10 days after the day of surgery. Method of measurement: Using Visual analogue scale (VAS). Amount of usage of prescribed pain relieving medication. Timepoint: Daily up to 10 days after surgery. Method of measurement: Asking the patient whether they took the prescribed pain relieving medication and if yes how many. Tabriz University of Medical Sciences Approved 2020-03-09 Ethics committee of tabriz university of medical sciences No. 96, 3rd hafez avenue, eil goli boulevard, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)