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IRCT20220517054898N1 IRCT 2023-09-03 Mazandaran University of Medical Sciences Comparison of Anahil Plus and Ibuprofen effect for pain relief after root canal treatment in patients referred to Amol private clinic - a clinical trial study Comparison of Anahil Plus and Ibuprofen effect for pain relief after root canal treatment in patients referred to Amol private clinic - a clinical trial study 2023-08-24 anticipated 90 Complete https://irct.ir/trial/63644 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Other design features: The maxillary and mandibular molar teeth, which have three canals and suffered from irreversible pulpitis, did not have periapical damage, and the patient expressed moderate pain intensity and anxiety level; they started studying. The teeth were worked on in two sessions, treated with pulpectomy and drugs were used between sessions.The diagnosis of irreversible pulpitis was determined according to the patients' dental history and radiological symptoms.The studied patients were randomly divided into three groups of 30 people A, B and C.Intervention group A Anahil Plus capsule containing 150 mg of bromelain and 300 mg of tromeric, Permon Amin Health Company, Tehran, Iran; every 8 hours up to 5 days (one dose was taken one hour before the treatment and every 8 hours up to 5 days after the treatment)Control group B, placebo drug (one dose was taken one hour before treatment and after treatment every 8 hours to 5 days) (capsule containing starch or carboxymethyl cellulose (CMC) every 8 hours to 5 days)Intervention group C received ibuprofen tablets (every eight hours for five days), Randomization description: The sampling method is two-stage. In the first stage, samples with entry criteria were selected using simple random sampling method. In the second stage, block sampling method was used for random allocation. The samples were assigned to three groups using block classification. Blocking process was done with Random Allocation software. The samples were placed in 3 blocks of 30 with the mentioned method, Blinding description: Due to the nature of the drugs, double-blinding is not possible, so it is unilaterally blinded and the only person recording the pain score is blinded without knowing the type of drugs. The current study is a single-strain blinding and the Placebo group is to compare the analgesic effect with Anahil Plus. 2 A patient with a three-channel maxilla and mandible molar tooth diagnosed with irreversible pulpitis (and the absence of periodontitis). Intervention 1: Intervention group:The studied patients are randomly divided into three groups of 30 people A, B and C.Intervention group A Anahil Plus capsule containing 150 mg bromelain and 300 mg tromeric, Permon Amin Health Company, Tehran, Iran; every 8 hours up to 5 days (one dose is taken one hour before treatment and after treatment every 8 hours up to 5 days)Infraalveolar block anesthesia is performed using 1.8 ml of 2% lidocaine with 1/80000 epinephrine (Darupakhsh, Iran). The tooth is isolated and prepared with rubber. Length determination is done with the help of periapical radiography. Cleaning and shaping is done with the help of passive preparation technique from apical to coronal. Saline and 2% hypochlorite are used as washing agents. Then the canals are dried with paper towels, calcium hydroxide and dressings are applied.The method of using the Visual Anxiety Scale or (VAS) pain questionnaire is taught to the patient. Before starting the work, patients are asked to record the pain score before endo treatment, 8 and 48 hours and on the fifth day after endo treatment. Intervention 2: Control group:Control group B, placebo drug (one dose is taken one hour before treatment and after treatment every 8 hours to 5 days) (capsule containing starch or carboxymethyl cellulose (CMC) every 8 hours to 5 days)Infraalveolar block anesthesia is performed using 1.8 ml of 2% lidocaine with 1/80000 epinephrine (Darupakhsh, Iran). The tooth is isolated and prepared with rubber. Length determination is done with the help of periapical radiography. Cleaning and shaping is done with the help of passive preparation technique from apical to coronal. Saline and 2% hypochlorite are used as washing agents. Then the canals are dried with paper towels, calcium hydroxide and dressings are applied.The method of using the Visual Anxiety Scale or (VAS) pain questionnaire is taught to the patient. Before starting the work, the patients were asked to record the pain score before endo treatment, 8 and 48 hours and on the fifth day after endo treatment.The standard treatment is the use of ibuprofen as an analgesic and pain reliever, that's why rescue dose (ibuprofen) is considered for the control group; That is, if he has pain, he can take ibuprofen and write down the number of doses taken. Intervention 3: Intervention group: Intervention group C receives ibuprofen tablets (every eight hours for five days).Infraalveolar block anesthesia is performed using 1.8 ml of 2% lidocaine with 1/80000 epinephrine (Darupakhsh, Iran). The tooth is isolated and prepared with rubber. Length determination is done with the help of periapical radiography. Cleaning and shaping is done with the help of passive preparation technique from apical to coronal. Saline and 2% hypochlorite are used as washing agents. Then the canals are dried with paper towels, calcium hydroxide and dressings are applied.The method of using the Visual Anxiety Scale or (VAS) pain questionnaire is taught to the patient. Before starting the work, patients are asked to record the pain score before endo treatment, 8 and 48 hours and on the fifth day after endo treatment. Yes - There is a plan to make this available What will be shared: After the completion of the project, the results will be delivered in the form of a final report and in electronic form (on a CD) to the Research Vice-Chancellor and Faculty of Dentistry of Mazandaran University of Medical Sciences When: The decision regarding access to the data will be the responsibility of the vice president of research and the Faculty of Dentistry of Mazandaran University of Medical Sciences, as well as the supervisor To whom: Vice President of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also a supervisor 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 to be used, and the use of the results only It is allowed by citing its source Where to obtain: Vice President of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also a supervisor How to obtain: A written request to the vice president of research or the Faculty of Dentistry of Mazandaran University of Medical Sciences and also obtaining the consent of the supervisor Comments:
public Narjes hoshyari
Khazar Blvd_Sari Faculty of dentistry
Sari Iran (Islamic Republic of) 4816895475 +98 11 3325 4135 narjeshoshyari@rocketmail.com Mazandaran University of Medical Sciences scientific Narjes Hoshyari
Khazar Blvd, Sari Faculty of Dentistry
Sari Iran (Islamic Republic of) 4816895475 +98 11 3325 4135 narjeshoshyari@rocketmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Irreversible pulpitis in three canal molar teeth Patients with pain before endo operation in the range of moderate pain (VAS 4-7) Patients with a minimum age of 20 Systemically healthy patients 20 years 60 years Both Patients with pain before endo operation in the range of severe pain Teeth diagnosed with necrosis and periapical periodontitis Patients with severe stress and anxiety Pregnant patients Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group:The studied patients are randomly divided into three groups of 30 people A, B and C.Intervention group A Anahil Plus capsule containing 150 mg bromelain and 300 mg tromeric, Permon Amin Health Company, Tehran, Iran; every 8 hours up to 5 days (one dose is taken one hour before treatment and after treatment every 8 hours up to 5 days)Infraalveolar block anesthesia is performed using 1.8 ml of 2% lidocaine with 1/80000 epinephrine (Darupakhsh, Iran). The tooth is isolated and prepared with rubber. Length determination is done with the help of periapical radiography. Cleaning and shaping is done with the help of passive preparation technique from apical to coronal. Saline and 2% hypochlorite are used as washing agents. Then the canals are dried with paper towels, calcium hydroxide and dressings are applied.The method of using the Visual Anxiety Scale or (VAS) pain questionnaire is taught to the patient. Before starting the work, patients are asked to record the pain score before endo treatment, 8 and 48 hours and on the fifth day after endo treatment. Control group:Control group B, placebo drug (one dose is taken one hour before treatment and after treatment every 8 hours to 5 days) (capsule containing starch or carboxymethyl cellulose (CMC) every 8 hours to 5 days)Infraalveolar block anesthesia is performed using 1.8 ml of 2% lidocaine with 1/80000 epinephrine (Darupakhsh, Iran). The tooth is isolated and prepared with rubber. Length determination is done with the help of periapical radiography. Cleaning and shaping is done with the help of passive preparation technique from apical to coronal. Saline and 2% hypochlorite are used as washing agents. Then the canals are dried with paper towels, calcium hydroxide and dressings are applied.The method of using the Visual Anxiety Scale or (VAS) pain questionnaire is taught to the patient. Before starting the work, the patients were asked to record the pain score before endo treatment, 8 and 48 hours and on the fifth day after endo treatment.The standard treatment is the use of ibuprofen as an analgesic and pain reliever, that's why rescue dose (ibuprofen) is considered for the control group; That is, if he has pain, he can take ibuprofen and write down the number of doses taken. Intervention group: Intervention group C receives ibuprofen tablets (every eight hours for five days).Infraalveolar block anesthesia is performed using 1.8 ml of 2% lidocaine with 1/80000 epinephrine (Darupakhsh, Iran). The tooth is isolated and prepared with rubber. Length determination is done with the help of periapical radiography. Cleaning and shaping is done with the help of passive preparation technique from apical to coronal. Saline and 2% hypochlorite are used as washing agents. Then the canals are dried with paper towels, calcium hydroxide and dressings are applied.The method of using the Visual Anxiety Scale or (VAS) pain questionnaire is taught to the patient. Before starting the work, patients are asked to record the pain score before endo treatment, 8 and 48 hours and on the fifth day after endo treatment. Pain intensity reported by patients based on the VAS scale. Timepoint: Before treatment_8 hours after treatment_48 hours after treatment_5 days after treatment. Method of measurement: The method of variable measurement is VAS questionnaire, the scale of this questionnaire is classified from zero to ten. The method of using the Visual Anxiety Scale (VAS) pain questionnaire was taught to the patient. Before starting the work, the patients were asked to record the pain score before endo treatment, 8 and 48 hours and on the fifth day after endo treatment. Mazandaran University of Medical Sciences Approved 2023-07-18 Ethics Committee of Mazandaran University of Medical Sciences Khazar Blvd, Sari Faculty of dentistry (tooba dental clinic) Sari Mazandaran Iran (Islamic Republic of)