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IRCT20230222057497N1 IRCT 2023-05-09 Mazandaran University of Medical Sciences Comparison of the Effect of Using Photobiomodulation with Platelet-Rich Fibrin on Dental Sockets Healing Clinical and Radiographic Evaluation of the Effect of Using Photobiomodulation in Comparison with Platelet-Rich Fibrin on Dental Sockets Healing: A Single-blind Randomized Clinical Trial 2023-05-31 anticipated 36 Complete https://irct.ir/trial/69308 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: ‏Using block classification, the samples will be assigned to two groups: C (control group (atraumatic extraction only) and T (intervention group (platelet-rich fibrin (PRF) along with photobiomodulation))). The blocking process is done using Excel software and the samples will be placed in 9 blocks of 4 (the total sample size is 36). ‏We will have six types of blocks of 4 such as TTCC, TCTC, TCCT, CCTT, CTCT, CTTC, where T is for the intervention group and C is for the control group. Using Excel software, numbers will be randomly generated 9 times with the RANDBETWEEN command in the range of 1 to 6 and according to the production values ​​of one of the blocks (for a production number 1 CTTC block, for a production number 2 CTCT blocks and so on) Samples will be allocated. For example, four people have come to the center, two people are supposed to enter the intervention group and two people are in the control group. In the Excel software, between the number one and six, the number two is supposed to be chosen by chance, so these four people are assigned to the CTCT block in the order of reference. In fact, the first person enters the control group, the second person enters the intervention group, the third person enters the control group, and the fourth person enters the intervention group, Blinding description: The Study Sequence will be hidden from the Person who Measures (Radiologist, Periodontist). 3 Platelet-Rich Fibrin, Photobiomodulation. Intervention 1: Intervention group: The nurse takes 10 ml of a blood sample from the median cubital vein of each patient and puts it in a dry test tube without anticoagulant. Then, they will be centrifuged in a centrifuge machine (BioHorizon,USA) at a speed of 3000 rpm for 10 minutes. The obtained PRF will be separated using a sterile tweezer. The PRF will be placed inside the socket and sutured with a 4-0 polyglycolic acid suture with a 19 needle (Suchers-Iran) using figure 8 suturing technique. Intervention 2: Control group: Immediately after tooth extraction, the socket is sutured with a 4-0 polyglycolic acid suture with a 19 needle (Suchers-Iran) using figure 8 suturing technique. The day after the extraction, the periodontist Uses a diode laser (Dentsply Sirona, Germany) with a wavelength of 660 nm,  power of 100 MW, and energy density of 2 j/cm2 for 10 seconds in three positions, i.e., buccally, lingually, and diagonally to the edge of the tissue. She will also perform it from the socket with the minimum possible distance to repair the soft tissue. Then, she will continuously use diode laser radiation (Dentsply Sirona, Germany) with a wavelength of 970 nm, power of 200 MW, and an energy density of 6 j/cm2 for 20 seconds to repair the hard tissue. The laser is irradiated by a low-power head (8 mm multi tip with a cross-sectional area of ​​1.5 cm2) in the buccal and lingual areas so that it covers half the length of the root each time. This protocol is repeated on the day after the extraction and then every other day for at least two weeks (1, 3, 6, 8, 10, 13, 15). Yes - There is a plan to make this available What will be shared: Vertical Height and Width of the Buccolingual Alveolar Ridge; Soft Tissue Healing; Width of Keratinized Gingiva; pain; Bone Density When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: The request should be sent to the responsible person after consultation with the research team, the data will be provided to the requesting person and it is necessary to give reference to the data owners in the articles or wherever the data is going to be used. Where to obtain: Avideh Maboudi Sadaf Complex, Narenj Alley, 15 Khordad Ave, Postal code 4818865454 989111531637 981133263345 avideh48188@yahoo.com How to obtain: Send the reason for the request to avideh48188@yahoo.com email address Comments:
public Avideh Maboudi
Sadaf Complex, Narenj Alley, 15 Khordad Ave
Sari Iran (Islamic Republic of) 4818865454 +98 11 3326 3345 avideh48188@yahoo.com Mazandaran University of Medical Sciences scientific Avideh Maboudi
Sadaf Complex, Narenj Alley, 15 Khordad Ave
Sari Iran (Islamic Republic of) 4818865454 +98 11 3326 3345 avideh48188@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients over 18 Years of Age Referring to the Special Clinic of the Sari Dental Faculty who have Extensive Irreparable Caries, Failed Root Canal Therapy, Periodontal Disease, Tooth Fracture, Indications for Extraction of Anterior Teeth and Premolars (Maxilla and Mandible) Intact Surrounding Alveolar Bone (Remaining Bone at least Two-Thirds of the Root Length) Tooth Socket with Four Healthy Walls after Extraction Patients Who Willing to Participate in the Study Teeth that Do not Require Surgical Methods to Remove and Do not Require Using of Surgical Burs Patients Who have the Ability to Participate in Examinations and Follow-up ASA I-II Patinets 18 years no limit Both Patients with Poor Oral Hygiene Pregnant or Lactating Women or Patients Who are Planning to Get Pregnant Smokers (More than ten Cigarettes per Day) and Alcoholism Patients with Uncontrolled Systemic Disease and History of Head and Neck Radiotherapy and Weak Immune System Chronic Treatment with Any Drug that Affects Bone Function: Heparin, Cyclosporine, Bisphosphonate, Chemotherapy Drugs Presence of Periapical or Periodontal Considerable Lesions around the Corresponding Teeth and Presence of Dehiscence and Fenestration in the Buccal Bone Plate Contraindications for Tooth Extraction Allergy to Any of the Study Products A Severe Acute lnfection or Any Other Factor that Limits the Opening of the Mouth Treatment - Other Treatment - Other Intervention group: The nurse takes 10 ml of a blood sample from the median cubital vein of each patient and puts it in a dry test tube without anticoagulant. Then, they will be centrifuged in a centrifuge machine (BioHorizon,USA) at a speed of 3000 rpm for 10 minutes. The obtained PRF will be separated using a sterile tweezer. The PRF will be placed inside the socket and sutured with a 4-0 polyglycolic acid suture with a 19 needle (Suchers-Iran) using figure 8 suturing technique Control group: Immediately after tooth extraction, the socket is sutured with a 4-0 polyglycolic acid suture with a 19 needle (Suchers-Iran) using figure 8 suturing technique. The day after the extraction, the periodontist Uses a diode laser (Dentsply Sirona, Germany) with a wavelength of 660 nm,  power of 100 MW, and energy density of 2 j/cm2 for 10 seconds in three positions, i.e., buccally, lingually, and diagonally to the edge of the tissue. She will also perform it from the socket with the minimum possible distance to repair the soft tissue. Then, she will continuously use diode laser radiation (Dentsply Sirona, Germany) with a wavelength of 970 nm, power of 200 MW, and an energy density of 6 j/cm2 for 20 seconds to repair the hard tissue. The laser is irradiated by a low-power head (8 mm multi tip with a cross-sectional area of ​​1.5 cm2) in the buccal and lingual areas so that it covers half the length of the root each time. This protocol is repeated on the day after the extraction and then every other day for at least two weeks (1, 3, 6, 8, 10, 13, 15) “Vertical height” and “buccolingual” width of alveolar ridge, “Soft tissue healing”, “Keratinized gingival width”, “Pain”, “Bone density”. Timepoint: At the beginning of the study (before the start of the study) and 8 weeks after tooth extraction. Method of measurement: Periodontal Probe, Visual Analogue Scale, Cone Beam CT Scan, Inspection, Fractal Analysis. Mazandaran University of Medical Sciences Approved 2023-01-07 Ethics committee of Mazandaran University of Medical Sciences Third floor, Mazandaran University of Medical Sciences, Research and Technology Deputy Buildin, Moalem Square Sari Mazandaran Iran (Islamic Republic of)