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IRCT20091118002736N2 IRCT 2019-09-25 Mashhad University of Medical Sciences The efficacy of LLLT in reducing complications of tooth extraction The efficacy of low level laser irradiation in reducing pain and accelerating socket healing after undisturbed tooth extraction 2019-09-24 anticipated 10 Complete https://irct.ir/trial/41534 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization The participants are randomly assigned to four groups using a random numbers table. The details of the allocated groups are recorded on cards contained in sequentially numbered, sealed, and opaque envelopes. These cards are prepared by an independent person who is not involved in the study protocol. Once the patient undergoes tooth extraction and agrees to participate in the trial, the allocation assignment is revealed by opening the envelope by this independent person, Blinding description: To provide double blind design of the study, neither the participants nor the subject who assesses the outcomes are aware of the group assignment. Regarding patient, blinding is so that in the probe is entered the mouth in all patients but the patient is not aware of the wavelength and does not know whether the probe is on or off. Regarding the assessor, the operator who delivers the pain questionnaires to the patient and the specialist who evaluates the degree of healing using photographs are not aware of the group assignment. N/A The patients who undergo molar extraction in the lower jaw.. Intervention 1: Intervention group : 1- irradiation with a 660 nm laser: the patients in group 1 (low level red laser) received irradiation from an indium-gallium-aluminum-phosphide (InGaAlP) low level laser (Thor DD2 Control Unit, Thor, London, UK). The laser emits a wavelength of 660 nm and operates at the output power of 200 mW at approximately 10 mm distance to the target area. The target areas are the lingual, buccal and occlusal surfaces of the extraction socket. The irradiation is performed for 30 seconds to each target area, delivering 6 J of energy with energy density of 4.21 J/cm2 per area. Laser exposure is performed after 30 to 60 minutes of extraction (day 1) and 2 days later (day 3). Intervention 2: Intervention group 2: The subjects in group 2 (low level infrared laser) are irradiated with a gallium- aluminum-arsenide (GaAlAs) low power laser (Thor DD2 Control Unit). This laser emits a wavelength of 810 nm at the power of 200 mW. The target areas and the duration of irradiation are similar to that in group 1, but the surface area of the probe is different. Therefore, 6 J of energy is delivered to each surface with energy density of 21.4 J/cm2,. Intervention 3: Intervention group 3: In group 3 (combination laser therapy), a combination of InGaAlP and GaAlAs diode lasers is used with exposure time of 15 seconds each. The energy delivered to the target area by the red or infrared lasers is 3 J with energy density of 2.1 J/cm2 for red wavelength and 10.7 J/cm2 for infrared wavelength. Intervention 4: Control group: The patients in group 4 (placebo) are considered as the control in whom the treatment is the same as that in group 1 but with no laser radiation. 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 There is no further information
public Farzaneh Ahrari
Dental research center, Vakilabad Blvd
Mashhad Iran (Islamic Republic of) 9177873476 +98 51 3882 9504 Ahrarif@mums.ac.ir Mashhad University of Medical Sciences scientific Farzaneh Ahrari
Department of Laser, School of dentistry, Vakilabad Blvd.
mashhad Iran (Islamic Republic of) 9177873476 +98 51 3882 9504 ahrarif@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) no history of underlying systemic disorders, smoking, pregnancy or breast feeding in females no active treatment with antibiotics, steroidal and non-steroidal anti-inflammatory drugs no sign of periodontal problems in the target teeth. 18 years 50 years Both the occurrence of dry socket (alveolar osteitis) at follow-up appointments the occurrence of trauma during the extraction process patients who had more than one tooth extraction at the same time. K08.8 Other specified disorders of teeth and supporting structures Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group : 1- irradiation with a 660 nm laser: the patients in group 1 (low level red laser) received irradiation from an indium-gallium-aluminum-phosphide (InGaAlP) low level laser (Thor DD2 Control Unit, Thor, London, UK). The laser emits a wavelength of 660 nm and operates at the output power of 200 mW at approximately 10 mm distance to the target area. The target areas are the lingual, buccal and occlusal surfaces of the extraction socket. The irradiation is performed for 30 seconds to each target area, delivering 6 J of energy with energy density of 4.21 J/cm2 per area. Laser exposure is performed after 30 to 60 minutes of extraction (day 1) and 2 days later (day 3). Intervention group 2: The subjects in group 2 (low level infrared laser) are irradiated with a gallium- aluminum-arsenide (GaAlAs) low power laser (Thor DD2 Control Unit). This laser emits a wavelength of 810 nm at the power of 200 mW. The target areas and the duration of irradiation are similar to that in group 1, but the surface area of the probe is different. Therefore, 6 J of energy is delivered to each surface with energy density of 21.4 J/cm2,. Intervention group 3: In group 3 (combination laser therapy), a combination of InGaAlP and GaAlAs diode lasers is used with exposure time of 15 seconds each. The energy delivered to the target area by the red or infrared lasers is 3 J with energy density of 2.1 J/cm2 for red wavelength and 10.7 J/cm2 for infrared wavelength. Control group: The patients in group 4 (placebo) are considered as the control in whom the treatment is the same as that in group 1 but with no laser radiation. Pain degree. Timepoint: at bedtime for 7 days following tooth extraction. Method of measurement: Visual analogue scale (VAS) for pain. Wound healing score. Timepoint: days 3 and 7 after tooth extraction. Method of measurement: assessing photographs and scoring the degree of socket wound healing using a 10-cm visual analogue scale. Mashhad University of Medical Sciences Approved 2016-01-13 The protocol of the present study was submitted to the ethical committee of Mashhad University of Me Dental research center, School of Dentistry, Vakilabad Blvd, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)