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IRCT20221207056746N1 IRCT 2023-05-31 Mazandaran University of Medical Sciences Comparison of the analgesic effect of three analgesics before surgery in pain after mandibular wisdom tooth surgery Comparing the analgesic effect of single-dose preoperative administration of noblegin, celecoxib and advalgin ER on demand for next dose of analgesic in mandibular third molar surgery 2022-11-02 anticipated 120 Complete https://irct.ir/trial/67355 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization (blocks of size 4); Individual. Randomization tool: random allocation software 2; How to make a random sequence and how to hide it: Using the software, codes A and B will be generated, where code A means applying the intervention group and code B means applying the control group for each person. 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: Patients, surgeon, data collector and biometrician will be unaware of the analgesic treatment (triple blind design). Medications and palcebo will be given to patients in dark matte jars of one color by the assistant before surgery so only the assistant is aware of the type of medicine. 2-3 postoperative pain. Intervention 1: Intervention group 1: pre-operative consumption of one Nobelgin tablet manufactured by Pars Daru Pharmaceuticals, each tablet contains acetaminophen 300 mg, caffeine 15 mg and codeine 15 mg. Intervention 2: Intervention group 2: pre-operative consumption of a 600 mg Advalgin AR coated tablet containing 200 mg ibuprofen in quick-release form and 400 mg in extended release form, manufactured by Abidi Pharmaceuticals. Intervention 3: Intervention group 3: pre-operative consumption of one 200 mg celecoxib capsule, manufactured by Elixir Pharmaceuticals. Intervention 4: Control group: pre-operative consumption of one placebo tablet (starch). 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 it is not planned yet
public Amirhossein Moaddabi
Sari Dental school, next to Tubi Clinic, Khazar Blvd, Sari
Sari Iran (Islamic Republic of) 4816895475 +98 11 3335 6194 A.moaddabi2@gmail.com Mazandaran University of Medical Sciences scientific Amirhossein Moaddabi
Sari Dental school, next to Tubi Clinic, Khazar Blvd, Sari
Sari Iran (Islamic Republic of) 4816895475 +98 11 3335 6194 A.moaddabi2@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Healthy patients (ASA class I) Candidates of prophylactic removal of mandibular third molar,full or partial bony impaction confirmed by panoramic X-ray Requiring soft tissue flap, bone manipulation and bone removal No medication consumption in the past 21 days The presence of the first and second molars Good oral hygiene Absence of pericoronitis or inflammation signs Absence of local or systemic infection 15 years 29 years Both Smokers Pregnant or breastfeeding women or women of child bearing potential not using adequate contraception Allergy or hypersensitivity to study treatments, rescue medication (rm) or any other nsaids, opioids and acetyl salicylic acid History of NSAID-sensitive asthma History of or the suspicion of drug or alcohol abuse Apical radiolucent image in target tooth Consmuption of central nervous system depressants Pre-existing pain and acute inflammation Inability to understand or perform the study procedure Psychosis Consumption of caffeine-containing beverages, chocolate, or alcohol within 4 hours prior to surgery Oral contraception use Being in the menstrual period Any contraindication of cox-2 inhibitors use G89 Pain, not elsewhere classified Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: pre-operative consumption of one Nobelgin tablet manufactured by Pars Daru Pharmaceuticals, each tablet contains acetaminophen 300 mg, caffeine 15 mg and codeine 15 mg Intervention group 2: pre-operative consumption of a 600 mg Advalgin AR coated tablet containing 200 mg ibuprofen in quick-release form and 400 mg in extended release form, manufactured by Abidi Pharmaceuticals Intervention group 3: pre-operative consumption of one 200 mg celecoxib capsule, manufactured by Elixir Pharmaceuticals Control group: pre-operative consumption of one placebo tablet (starch) Postoperative pain intensity. Timepoint: 4hours & 7 hours postsurgery,the first day and the third day after surgery. Method of measurement: Visual Analogue Scale. The time of first analgesic intake. Timepoint: one week after surgery. Method of measurement: Referring to document. The number of patients who needed analgesics (vasā‰„4). Timepoint: One week after surgery. Method of measurement: Referring to patients' documents. The total number of analgesics used. Timepoint: One week after surgery. Method of measurement: Referring to patients' documents. superviser & sari dental school Approved 2022-12-24 Ethics committee of Mazandaran University of Medical Sciences Third floor; Mozoun 20 building, Bustan1, Pasdar alley,Imam square Sari Mazandaran Iran (Islamic Republic of)