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IRCT20191019045159N1 IRCT 2019-12-04 Islamic Azad University Effect of Low-Level Laser Therapy on Bone Loss around Dental Implants Effect of Postoperative 660 nm Low-Level Laser Therapy on the Radiographic Crestal Bone Loss of Fresh Socket Implants 2019-05-22 anticipated 30 Complete https://irct.ir/trial/43119 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Thirty patients were randomly divided into two groups: laser (intervention) and no-laser groups (control). Random allocation list was generated using randomization software (RandList version 1.2; DatIng GmbH, Tübingen, Deutschland). Each patient could just provide an area for implant treatment, Blinding description: The stages of the study were described for each patient and the volunteers who completed the study completed the written informed consent form and entered the study. We placed the laser on the patient's surgical area in control group ,but no laser emission is received to them to avoid bias during the study. The amount of bone resorption was calculated by a radiologist using the software to identify the smallest pixel identifiable from the bone. The person who calculated the amount of bone resorption by software from the patient's graphs was blinded regarding group assignment. The data analyzer also did not know whether the patients were in the intervention or control group and the data were given to him as groups one and two. N/A Crestal Bone Loss. Intervention 1: Intervention group: After selection of the patients based on eligibility criteria, local anesthesia was performed by injecting 2% lidocaine (with adrenaline 1/80000). After cutting the crestal and removing the mucoperiosteal flap and extracting the tooth without trauma, preparation of bone -level implant recipient was done under cooling with physiological serum solution, in terms of the manufacturer's protocol (Dio, Seoul, Korea). For all implants, a speed of 15rpm with a torque of 35-40 Ncm was used. Diameter of the implants was chosen so that, at least 1 mm of bone remained on both buccal and palatal sides after implant placement. For vertical positioning, the implant should also be positioned in the same level of buccal bone crest. After implantation, the implant was implanted with the surrounding mucosa and the area was sutured, and the sutures were removed by passing 7 days from surgery. After the surgery, all the patients received amoxicillin (1.5 g) or clindamycin (1.8 g) daily for 3 days as well as non-steroidal anti-inflammatory drug for pain relief and mouthwash. The patients were also received advice regarding oral hygiene. No temporary dentures were placed during the 4-month follow-up.A low-level 660 nm diode laser illuminated to surrounding tissues of the implant along its longitudinal axis was applied in this study. Low-Level Laser Treatment (LLLT) was started immediately after the surgery and was repeated three times per week for 2 weeks. Total radiation dose per treatment for each implant unit was 6.26 J / cm². Output power was checked before working with the power meter. Intervention 2: Control group: After selection of the patients based on eligibility criteria, local anesthesia was performed by injecting 2% lidocaine (with adrenaline 1/80000). After cutting the crestal and removing the mucoperiosteal flap and extracting the tooth without trauma, preparation of bone -level implant recipient was done under cooling with physiological serum solution, in terms of the manufacturer's protocol (Dio, Seoul, Korea). For all implants, a speed of 15rpm with a torque of 35-40 Ncm was used. Diameter of the implants was chosen so that, at least 1 mm of bone remained on both buccal and palatal sides after implant placement. For vertical positioning, the implant should also be positioned in the same level of buccal bone crest. After implantation, the implant was implanted with the surrounding mucosa and the area was sutured, and the sutures were removed by passing 7 days from surgery. After the surgery, all the patients received amoxicillin (1.5 g) or clindamycin (1.8 g) daily for 3 days as well as non-steroidal anti-inflammatory drug for pain relief and mouthwash. To implants in the control group, the laser did not shine. We placed the laser on the patient's surgical area in control group ,but no laser emission is received to them to avoid bias during the study. Yes - There is a plan to make this available What will be shared: All potential data can be shared after unidentifiable people When: Start of access period 6 months after printing results To whom: Data will be available to researchers working in academia and in the industry as well. Conditions: All the scientific analyzes that are required to advance science and industry are permitted on the data of this study. Where to obtain: For any information you can send an email to this email address: Alireza_sigharydeljavan@yahoo.com How to obtain: For recieving these documents you can send your Individual specifications and desired request to this email address: Alireza_sigharydeljavan@yahoo.com Comments:
public Alireza Sighari Deljavan
Unit 25, Kasra Apartment, Kasra Alley, Beheshti Street, Isfahan.
Isfahan Iran (Islamic Republic of) 8184865759 +98 31 3535 4123 Alireza_sigharydeljavan@yahoo.com Islamic Azad University scientific Alireza Sighary Deljavan
Unit 25, Kasra Apartment, Kasra Alley, Beheshti Street, Isfahan.
Isfahan Iran (Islamic Republic of) 8184865759 +98 31 3535 4123 Alireza_sigharydeljavan@yahoo.com Islamic Azad University Iran (Islamic Republic of) Individuals referred to the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Islamic Azad University, Isfahan, Iran, were treated with tooth extraction and implant placement. patients without inflammation or gingivitis. Healthy adults who are at least 18 years old. Sufficient bone density to receive the implant without the need for bone augmentation. no history of tooth extraction within selected 6 months. Having at least 6 mm bucco-lingual ridge width at the site of implant placement for inserting an implant at least 4 mm in diameter in ideal position. 18 years no limit Both pregnancy or lactation systemic diseases affecting osseointegration using anticoagulants systemic glucocorticoid therapies history of radiotherapy in craniofacial region in the last 12 months smoking more than 10 cigarettes per day mouth cancer history of seizures Acute oral infection Untreated or uncontrolled periodontal disease Prevention Placebo Intervention group: After selection of the patients based on eligibility criteria, local anesthesia was performed by injecting 2% lidocaine (with adrenaline 1/80000). After cutting the crestal and removing the mucoperiosteal flap and extracting the tooth without trauma, preparation of bone -level implant recipient was done under cooling with physiological serum solution, in terms of the manufacturer's protocol (Dio, Seoul, Korea). For all implants, a speed of 15rpm with a torque of 35-40 Ncm was used. Diameter of the implants was chosen so that, at least 1 mm of bone remained on both buccal and palatal sides after implant placement. For vertical positioning, the implant should also be positioned in the same level of buccal bone crest. After implantation, the implant was implanted with the surrounding mucosa and the area was sutured, and the sutures were removed by passing 7 days from surgery. After the surgery, all the patients received amoxicillin (1.5 g) or clindamycin (1.8 g) daily for 3 days as well as non-steroidal anti-inflammatory drug for pain relief and mouthwash. The patients were also received advice regarding oral hygiene. No temporary dentures were placed during the 4-month follow-up.A low-level 660 nm diode laser illuminated to surrounding tissues of the implant along its longitudinal axis was applied in this study. Low-Level Laser Treatment (LLLT) was started immediately after the surgery and was repeated three times per week for 2 weeks. Total radiation dose per treatment for each implant unit was 6.26 J / cm². Output power was checked before working with the power meter. Control group: After selection of the patients based on eligibility criteria, local anesthesia was performed by injecting 2% lidocaine (with adrenaline 1/80000). After cutting the crestal and removing the mucoperiosteal flap and extracting the tooth without trauma, preparation of bone -level implant recipient was done under cooling with physiological serum solution, in terms of the manufacturer's protocol (Dio, Seoul, Korea). For all implants, a speed of 15rpm with a torque of 35-40 Ncm was used. Diameter of the implants was chosen so that, at least 1 mm of bone remained on both buccal and palatal sides after implant placement. For vertical positioning, the implant should also be positioned in the same level of buccal bone crest. After implantation, the implant was implanted with the surrounding mucosa and the area was sutured, and the sutures were removed by passing 7 days from surgery. After the surgery, all the patients received amoxicillin (1.5 g) or clindamycin (1.8 g) daily for 3 days as well as non-steroidal anti-inflammatory drug for pain relief and mouthwash. To implants in the control group, the laser did not shine. We placed the laser on the patient's surgical area in control group ,but no laser emission is received to them to avoid bias during the study. Crestal Bone Loss. Timepoint: immediately after the surgery and also by passing 4 months from that. Method of measurement: Bone quantification at the implant site was assessed using periapical intraoral radiograph and computerized software. Vice chancellor for research of Islamic Azad University of Isfahan Approved 2018-09-12 Ethics committee of Islamic Azad University of Isfahan Jey st Isfahan Isfehan Iran (Islamic Republic of)