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IRCT20110420006239N2 IRCT 2019-06-07 Tabriz University of Medical Sciences Evaluating the Effectiveness of Red and Infrared Low Level laser Therapy on Pain Control after Removal of Impacted Wisdom Teeth LLLT Comparison of the Effectiveness of Red and Infrared Low level Laser Therapy for Post Operative Pain Control,Swelling and Trismus in Patients with Impacted Mandibular Third Molar 2019-04-09 anticipated 30 Complete https://irct.ir/trial/38352 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is achieved through www.randomization.org website in 3 groups of 10 from number 1 to 30, Blinding description: Switching on /off of the laser therapy device is controlled by the responsible nurse and the patient and the researcher are blind. 3 Condition 1: Trismus. Condition 2: Pain. Condition 3: Swelling. Condition 4: Total analgesic drug consumption. Intervention 1: Intervention group:In first group red laser(with the wavelength of 660 nm and the power of 6 joules per square centimeter)is applied extraorally on 2 occasions, once 30 minutes before the impacted lower 3rd molar surgery and the other one is performed on the second day after operation. Irradiation will be performed by positioning the laser probe in contact with the skin on four points of the masseter muscle: 1 –, lower region (near the mandibular insertion); 2 –, lower middle region; 3 –, upper middle region; and 4 –, upper region (near the insertion of the zygomatic arch). The laser will be applied for 7 minutes at each point. Intervention 2: Intervention group: In the second group infra red laser(with the wavelength of 890 nm and the power of 6 joules per square centimeter) is applied extraorally on 2 occasions, once 30 minutes before the impacted lower 3rd molar surgery and the other one is performed on the second day after operation. Irradiation will be performed by positioning the laser probe in contact with the skin on four points of the masseter muscle: 1 –, lower region (near the mandibular insertion); 2 –, lower middle region; 3 –, upper middle region; and 4 –, upper region (near the insertion of the zygomatic arch).The laser will be applied for 5 minutes at each point. Intervention 3: Control group: Placebo laser(off laser) is applied extraorally on 2 occasions, once 30 minutes before the impacted lower 3rd molar surgery and the other one is performed on the second day after operation. Placebo laser therapy will be performed by positioning the laser probe in contact with the skin on four points of the masseter muscle: 1 –, lower region (near the mandibular insertion); 2 –, lower middle region; 3 –, upper middle region; and 4 –, upper region (near the insertion of the zygomatic arch). 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 more information
public Javad Yazdani
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave.
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 6965 Yazdanij@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Javad Yazdani
Dentistry faculty of Tabriz, Golgasht Ave.
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3335 5965 Yazdanij@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients admitted to the dental clinic who require the removal of impacted lower 3rd molar Patients who have impacted lower 3rd molar with grade lllB or IIIC surgical difficulty according to Pell-Gregory classification Patients who have mesioangular impacted lower 3rd molar Patients without any systemic disease 18 years 35 years Both Patients with distoangular or vertical impacted lower 3rd molar Soft tissue impaction of the lower 3rd molar Hypersensitivity to local anesthetics Patients with systemic disease Local infection Blood dyscrasias Patients with a history of gastric ulcer or patients who are currently suffering from a gastric ulcer Cardiovascular condition Pregnancy Lactation Patients who have used analgesic or anti inflammatory drugs 24 hours prior surgery Surgical procedures taking longer than 20 minutes R25.2 R52 R60 Y45.3 Cramp and spasm Pain, unspecified Edema, not elsewhere classified Other nonsteroidal anti-inflammatory drugs [NSAID] Treatment - Devices Treatment - Devices Placebo Intervention group:In first group red laser(with the wavelength of 660 nm and the power of 6 joules per square centimeter)is applied extraorally on 2 occasions, once 30 minutes before the impacted lower 3rd molar surgery and the other one is performed on the second day after operation. Irradiation will be performed by positioning the laser probe in contact with the skin on four points of the masseter muscle: 1 –, lower region (near the mandibular insertion); 2 –, lower middle region; 3 –, upper middle region; and 4 –, upper region (near the insertion of the zygomatic arch). The laser will be applied for 7 minutes at each point. Intervention group: In the second group infra red laser(with the wavelength of 890 nm and the power of 6 joules per square centimeter) is applied extraorally on 2 occasions, once 30 minutes before the impacted lower 3rd molar surgery and the other one is performed on the second day after operation. Irradiation will be performed by positioning the laser probe in contact with the skin on four points of the masseter muscle: 1 –, lower region (near the mandibular insertion); 2 –, lower middle region; 3 –, upper middle region; and 4 –, upper region (near the insertion of the zygomatic arch).The laser will be applied for 5 minutes at each point. Control group: Placebo laser(off laser) is applied extraorally on 2 occasions, once 30 minutes before the impacted lower 3rd molar surgery and the other one is performed on the second day after operation. Placebo laser therapy will be performed by positioning the laser probe in contact with the skin on four points of the masseter muscle: 1 –, lower region (near the mandibular insertion); 2 –, lower middle region; 3 –, upper middle region; and 4 –, upper region (near the insertion of the zygomatic arch). Pain. Timepoint: Day 2 post-operation, day 7 post-operation. Method of measurement: Visual analog scale (asking from patient, scoring from 1 to 10). Swelling. Timepoint: Pre-operation, day 2 post-operation, day 7 post-operation. Method of measurement: Measuring 3 parameters: 1-tragus-labial commissure distance, 2- Lateral canthus of eye-mandibular angle distance, 3-tragus–pogonion distance. Trismus. Timepoint: Pre-operation, day 2 post-operation, day 7 post-operation. Method of measurement: Measuring the maximum space between central incisors of maxilla and mandible( in millimeter). Number of pain relief tablets taken. Timepoint: Day 2 post-operation, day 7 post-operation. Method of measurement: Asking the patient. Tabriz University of Medical Sciences Approved 2019-03-11 Ethics committee of Tabriz University of Medical Sciences Dentistry faculty of Tabriz, Golgasht Ave. Tabriz East Azarbaijan Iran (Islamic Republic of)