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IRCT20220119053766N1 IRCT 2022-03-17 Tehran University of Medical Sciences- faculty of dentistry Evaluating the effect of photobiomodulation therapy with diode laser on peri-implant soft tissue healing following uncovering. Evaluating the effect of photobiomodulation therapy with 445 nm diode laser on peri-implant soft tissue healing following uncovering: a triple-blind, split-mouth, randomized controlled trial. 2022-07-23 anticipated 10 Complete https://irct.ir/trial/61528 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using a simple randomized method, one side of the mouth is considered as the intervention area and the other side of the mouth is considered as the control. A randomization list will be prepared by the statistics consultant using the RAND function in Excel software and will be provided to the researcher. In the intervention area, the soft tissue around the desired dental implant will be exposed by laser. In the control area, the laser device probe will be used in off mode in the soft tissue area around the desired dental implant, Blinding description: In this study, the patient, the evaluator (consisting of two periodontists and a maxillofacial surgeon who measures the outcomes of the study based on the EHS index), and the statistical analyst (statistics consultant) will be blinded by the intervention and control. During laser treatment, goggles are placed on the patient's eyes. The patient will not feel any heat changes or pain during the laser treatment. The device probe is used on the control side at the same time as intended on the intervention side in off mode. The patient (according to the above points) will be blind to which side of the mouth he receives the laser. The laser operator is not blind to the assignment of the laser to either side of the mouth, but the person measuring the results of the study will be blind to this assignment. Also, labels A and B are considered for both intervention and control so that the statistical analyst is blind to the end of the data analysis relative to the allocation. N/A Evaluating the effect of photobiomodulation therapy with 445 nm diode laser on peri-implant soft tissue healing following uncovering. Intervention 1: Intervention group:Initially, to start the process; local anesthesia with local infiltration technique in the maxilla or inferior alveolar nerve block in the mandible with 2% lidocaine anesthetic solution and epinephrine 1/100000 (Elixir Pharmaceutical Company, 1.8 ml)will be done . After uncovering by a surgeon with midcrestal incision and mucoperiosteal flap elevation and healing abutment insertion(after three months) with absorptive sutures (vicryl 000, 19 mm, reverse cut) by simple interrupted method (one in front And another behind the healing), on days zero (immediately after surgery), third, seventh and fourteenth after surgery with a 445 nm blue diode laser with specifications (SIRO Laser Blue, Sirona Dental SystemsGmbH, Bensheim, Germany) at a power of 200 mW and in continuous wave mode with handpiece therapy to a cross section of 0.5 cm2 for 15 seconds and a density energy of 6 J / cm2 will be irradiated by a laser operator (one of the researchers) in each of the two buccal and lingual areas. Intervention 2: Control group:In the control area, the laser device probe will be used in off mode in the soft tissue area around the desired dental implant. Yes - There is a plan to make this available What will be shared: Data file and statistical analysis will be shared When: 3 months after data collection To whom: The above information will be made available to the public in the form of appendices along with the published article Conditions: To better understand the study findings as well as a reference for future studies. Where to obtain: website of the journal where the article will be published. How to obtain: The data file and statistical analysis will be available to everyone Comments:
public Nima Dehghani
North Karegar St,Tehran-Iran
Tehran Iran (Islamic Republic of) 14399-55991 P.O.BOX: +98 21 8801 5801 nimadt2002@yahoo.com Tehran University of Medical Sciences- School of Dentistry scientific Nima Dehghani
North Karegar St,Tehran-Iran
Tehran Iran (Islamic Republic of) 14399-55991 P.O.BOX: +98 21 8801 5801 nimadt2002@yahoo.com Tehran University of Medical Sciences- School of dentistry Iran (Islamic Republic of) 1) Patients who have received dental implants in a two-stage (conventional) method, bilaterally in one jaw(maxilla or mandible), and need healing abutment of a same size. 2) People over 18 years old. 3) No smoking, tobacco and other tobacco and alcohol consumption in the last six months. 4) Patients who have a good oral hygiene. (Patients are evaluated with O'Leary plaque index; and plaque index less than 10% is considered as good oral hygiene). 5) bleeding score less than 25% in 6 areas of each tooth 6) No history of periodontal treatment in the surgical area in the past year. 18 years no limit Both 1) Patients with uncontrolled systemic disease (uncontrolled diabetes, immunodeficiency and uncontrolled periodontal disease). 2) Pregnant and lactating women. 3) People allergic to the drugs used in the study. 4) History of IV bisphosphonates consumption during the past three years and oral mode over ten years. 5) History of radiotherapy and chemotherapy in the head and neck area. 6) People who need advanced soft tissue management procedures (patients who have soft tissue defects or have extra soft tissue in the area). 7) Candidates of fresh socket implant method. Treatment - Other Placebo Intervention group:Initially, to start the process; local anesthesia with local infiltration technique in the maxilla or inferior alveolar nerve block in the mandible with 2% lidocaine anesthetic solution and epinephrine 1/100000 (Elixir Pharmaceutical Company, 1.8 ml)will be done . After uncovering by a surgeon with midcrestal incision and mucoperiosteal flap elevation and healing abutment insertion(after three months) with absorptive sutures (vicryl 000, 19 mm, reverse cut) by simple interrupted method (one in front And another behind the healing), on days zero (immediately after surgery), third, seventh and fourteenth after surgery with a 445 nm blue diode laser with specifications (SIRO Laser Blue, Sirona Dental SystemsGmbH, Bensheim, Germany) at a power of 200 mW and in continuous wave mode with handpiece therapy to a cross section of 0.5 cm2 for 15 seconds and a density energy of 6 J / cm2 will be irradiated by a laser operator (one of the researchers) in each of the two buccal and lingual areas. Control group:In the control area, the laser device probe will be used in off mode in the soft tissue area around the desired dental implant Early Wound Healing Score (EHS). Timepoint: Days 3, 7, 14 before the laser and also in the 21st day session. Method of measurement: By the Early Wound Healing Score (EHS) in the data collection form. Patient evaluation of pain and discomfort in the surgical area. Timepoint: On each of the 3, 7, 14 days before the laser and also on the 21st day after surgery. Method of measurement: Assessment of pain and discomfort in the surgical area, which is scored by the patient himself with a visual analog scale in the form of a 10 cm linear segment. The lowest score indicates the least pain and the highest score indicates the most pain and discomfort in the surgical area. Tehran University of Medical Sciences- faculty of dentistry Approved 2021-10-30 Ethics committee of Tehran University of Medical Sciences-faculty of dentistry North Karegar St,Tehran-Iran Tehran Tehran Iran (Islamic Republic of)