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IRCT20221228056958N1 IRCT 2023-02-18 Mazandaran University of Medical Sciences The Effect of local dexamethasone injection after immediate implant placement The Effect of local dexamethasone injection after immediate implant placement 2023-02-20 anticipated 60 Complete https://irct.ir/trial/67666 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Block randomization (blocks of 4); Individual Randomization tool: The software of random allocation 2 Procedure of making a random sequence and hiding it: Using the software, codes A and B will be generated, where code A means the application of the dexamethasone group and code B means the application of the control group for each individual. Finally, the codes will be placed in the sealed envelope and the number of each patient will be written on the envelope. As each patient enters, the doctor will open the envelope and apply the desired treatment, Blinding description: The person who follows the patients and records their pain and swelling levels will not be aware of the patient's group, and only the surgeon will be aware of the patient's groups. Also, none of the patient and control groups know whether the local injection was done(There is a placebo). 3 Pain and swelling after immediate implant placement surgery. Intervention 1: Intervention group: For local anesthesia, lidocaine 2% with epinephrine 1:100,000 is used. All patients (both groups) receive the same surgery and drug except dexamethasone. The implant used in the Bone level study will be with SLA level, two-stage surgery (screw closure), and cover the implant with gum. The minimum amount of initial stability for implants was considered to be 15 newtons. If the distance between the implant and the extracted tooth cavity is more than 2 mm, it is filled with xenograft grafting material. After completing the surgery and washing the area with normal saline, the incision site is sutured with 0-5 nylon thread and immediately injecting a dose of dexamethasone (1/3 vial of dexamethasone 8 mg Alborz Daro Pharmaceuticals) with an insulin syringe in the depth of the vestibule near the implanted tooth is done. Prescription medicine is amoxicillin 500 every 8 hours for 1 week and 0.2% chlorhexidine mouthwash (twice a day). Intervention 2: Control group: Anesthesia and surgery procedures and prescribed drugs are similar to the intervention group, but dexamethasone is not injected and instead, 1/3 vial of 2% lidocaine with epinephrine 1:100,000 is injected with an insulin syringe in the depth of the vestibule adjacent to the implanted tooth. 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 Najmeh Sadat Valed Saravi
Farhang 16, Farhang St
Sari Iran (Islamic Republic of) 1133314614 +98 11 3331 4614 Dr.valed@gmail.com Mazandaran University of Medical Sciences scientific Najmeh Sadat Valed Saravi
Farhang 16, Farhang St
Sari Iran (Islamic Republic of) 1133314614 +98 11 3331 4614 Dr.valed@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) People from 18 to 60 years old 18 years 60 years Both Pregnant people, , ,, sensitivity to the drugs used in the study, and . Threatening systemic disease AIDS Weak immune system Recent use of antibiotics and anti-inflammatory drugs Cushing's syndrome Cataracte Psychosis Acute or chronic infection Tuberculosis (active and treated) Oral herpes simplex Treatment - Drugs Treatment - Drugs Intervention group: For local anesthesia, lidocaine 2% with epinephrine 1:100,000 is used. All patients (both groups) receive the same surgery and drug except dexamethasone. The implant used in the Bone level study will be with SLA level, two-stage surgery (screw closure), and cover the implant with gum. The minimum amount of initial stability for implants was considered to be 15 newtons. If the distance between the implant and the extracted tooth cavity is more than 2 mm, it is filled with xenograft grafting material. After completing the surgery and washing the area with normal saline, the incision site is sutured with 0-5 nylon thread and immediately injecting a dose of dexamethasone (1/3 vial of dexamethasone 8 mg Alborz Daro Pharmaceuticals) with an insulin syringe in the depth of the vestibule near the implanted tooth is done. Prescription medicine is amoxicillin 500 every 8 hours for 1 week and 0.2% chlorhexidine mouthwash (twice a day). Control group: Anesthesia and surgery procedures and prescribed drugs are similar to the intervention group, but dexamethasone is not injected and instead, 1/3 vial of 2% lidocaine with epinephrine 1:100,000 is injected with an insulin syringe in the depth of the vestibule adjacent to the implanted tooth. Pain score. Timepoint: 2 , 4 and 7 days after surgery. Method of measurement: Visual Analogue Scale. Swelling score. Timepoint: 2 , 4 and 7 days after surgery. Method of measurement: Visual Analogue Scale. Mazandaran University of Medical Sciences Approved 2022-12-10 Ethics committee of Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences, Jouybar Intersection, Imam Sqr. Sari Mazandaran Iran (Islamic Republic of)