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IRCT20221023056272N1 IRCT 2023-04-29 Ahvaz University of Medical Sciences Evaluation the effect of low level laser therapy in management of the complications after guided bone regeneration(GBR) surgeries. Evaluation of the effect of using low level laser therapy in management of the complications of guided bone regeneration(GBR) surgeries in patients who need this surgery 2023-04-21 anticipated 22 Complete https://irct.ir/trial/66509 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A list of 22 characters consisting of 11 characters A (representative of the laser radiation group) and 11 characters B (representative of the group without laser radiation (placebo)) is created by simple randomization using the envelope-in-package method, and the patients are placed in one of groups A or B according to the order of their referral, Blinding description: Participant: For all the people participating in the study, the laser irradiation process is performed , the difference is that for the intervention group, the laser irradiation process is performed with the laser on, and for the control or placebo group, the laser irradiation process is performed with the laser off. Outcome assessor (clinical examiner): the clinical examiner does the patient's examination without being aware of the patient's group and records the necessary information. Data analyst: The data analyst or statistical consultant will analyze the data of each group without knowing witch group is the control and which is the intervention. 3 Post-operative complications of guided bone regeneration. Intervention 1: Intervention group: Laser radiation: In the laser radiation group, immediately after the surgery for each patient, the surgical site will be irradiated with Diode laser with a wavelength of 940 nm and a power of 300 mW and 16 seconds for each cm2 of the lesion. The necessary dose for laser therapy is 5 j/〖cm〗^2 (we will have 16 seconds of radiation for each cm2). According to the explained method, the same amount of energy is again irradiated to the desired area 48 hours after the surgery. Intervention 2: Control group: In the control group, laser irradiation is performed with the device turned off at the same time as the intervention group. 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 Privacy of patient's personal information
public Asma Moghadasi
Floor. 2, No. 12, East Elham, Kianpars Street
Ahwaz Iran (Islamic Republic of) 6155843651 +98 61 3333 5830 asma.moghadasi98@gmail.com Ahvaz University of Medical Sciences scientific Asma Moghadasi
East elham, kianpars streat, Ahwaz town
Ahwaz Iran (Islamic Republic of) 6155843651 +98 933 177 4942 moghadasi.a@ajums.ac Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients must be medically healthy Having healthy oral mucosa. Not having the history of implant failure at the surgical site or contraindications for implant placement Patients must be in need of bone grafting for placement of implant Cases, with maximum 0.5cc bone powder required for bone grafting, are going to be chosen The surgical field should be limited to 1 to 3 teeth Patients should not use removable prosthesis or similar items No history of medical conditions that might delay wound healing process such as: diabetes, smoking, and alcohol consumption. 20 years 60 years Both Lack of Patient's cooperation Having photosensitivity Patients who have used antibiotics and corticosteroids for any reason in the last 2 weeks T88.8XXA Other specified complications of surgical and medical care, not elsewhere classified, initial encounter Treatment - Devices Placebo Intervention group: Laser radiation: In the laser radiation group, immediately after the surgery for each patient, the surgical site will be irradiated with Diode laser with a wavelength of 940 nm and a power of 300 mW and 16 seconds for each cm2 of the lesion. The necessary dose for laser therapy is 5 j/〖cm〗^2 (we will have 16 seconds of radiation for each cm2). According to the explained method, the same amount of energy is again irradiated to the desired area 48 hours after the surgery. Control group: In the control group, laser irradiation is performed with the device turned off at the same time as the intervention group. The VAS(visual analog scale) number of pain intensity declared by patients. Timepoint: At 12, 24, 48, 72 hours after surgery. Method of measurement: based on VAS (visual analog scale). The assigned number of the hemostasis status. Timepoint: On second day after surgery. Method of measurement: The number assigned to each hemostasis status is based on the following classification: 0 for the presence of bleeding in the wound margin/1 for the presence of fibrin in the wound margin/2 for the absence of fibrin in the wound margin. Determining the degree of wound healing based on assigned numbers. Timepoint: On the seventh day after surgery. Method of measurement: Wound healing is graded as follows: 0 for complete wound healing / 1 for wound healing and the presence of a thin line of fibrinous membrane / 2 for wound healing and the presence of fibrin / 3 for incomplete wound closure and the presence of a gap/ 4 no wound healing (necrosis). Determining the degree of inflammation based on two factors: 1) the degree of redness of the wound margin 2) presence or absence of extraoral swelling. Timepoint: On the second and seventh day after surgery. Method of measurement: To check the redness of the wound margin, the following grading is used: 0 for redness over 50% of the length of the wound margin / 1 for redness less than 50% of the length of the wound margin / 2 no redness. The number and dose of painkillers taken by the patient. Timepoint: On seventh day after surgery. Method of measurement: After the surgery, the patient is given a table and asked to make notes in the table after receiving each painkiller. And the table is delivered on the seventh day. Ahvaz University of Medical Sciences Approved 2023-04-08 Ethics committee of Ahwaz University of Medical Sciences 4th Floor ,No.12, Elham sharghi Street. Kianpars Street Ahwaz Khouzestan Iran (Islamic Republic of)