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IRCT20251029067813N1 IRCT 2025-11-07 Khoram-Abad University of Medical Sciences Effect of topical Dexamethasone in the dental socket after surgery Investigating the Effect of Topical Dexamethasone in Alveolar Socket on Pain and Complications After Impacted third molar Tooth Surgery: Clinical trial 2025-11-15 anticipated 52 Complete https://irct.ir/trial/87174 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, participants will be assigned to the intervention and control groups using stratified randomization. Stratification will be performed based on two variables: gender (male and female) and education level (below diploma, diploma, university), resulting in a total of six strata. Within each stratum, participants will be allocated using permuted block randomization with variable block sizes of four and six to maintain balance in the number of participants between the two groups. The random allocation sequence in each stratum will be generated and recorded by an independent biostatistician (who is not involved in the surgery or outcome assessment) using a table of random numbers and the statistical software International Business Machines Statistical Package for the Social Sciences (version 26). The unit of randomization will be the individual participant. To ensure allocation concealment, opaque, sealed, and sequentially numbered envelopes will be used. Each envelope will contain a card indicating the assigned treatment group (dexamethasone or placebo). The envelopes will be opened only at the time of surgery by a person who is not involved in the assessment process. Thus, both the participant and the outcome assessor will be blinded to the type of intervention, and the study will be conducted in a double-blind manner. The coded allocation list will be kept by an independent person outside the research team and will be opened only after the completion of data collection, Blinding description: Neither the Patient nor the Evaluator has any information about the type of Treatment assigned to the Subjects. The Code Breaker is also a person outside the Research Team. Written Informed Consent will be obtained from all Patients for participation in the Study as well as for the Surgical Extraction of the Third Molar. However, the Patients will not be informed whether the administered Drug is Dexamethasone or Placebo. 3 The socket caused by impacted wisdom tooth surgery. Intervention 1: Intervention group: local anesthetic injection of inferior alveolar and long buccal nerve block with 2% lidocaine carpol containing epinephrine at 80000:1 will be performed, after which a sulcular incision and creation of a pocket flap will be made to expose the surgical area, and then the impacted wisdom tooth will be extracted. After that, the surgical area will be washed with 100 ml of normal saline, and in the next step, a piece of foam gel is soaked with 4 mg of dexamethasone manufactured by Iran Hormone Pharmaceutical Company and placed in the dental socket, and finally, it will be performed with a 04 nylon suture, then standard drug therapy with acetaminophen will be performed every 6 hours. Intervention 2: Control group: for patients, local anesthesia injection of inferior alveolar and long buccal nerve block with 2% lidocaine carpol containing epinephrine at 80000:1 will be performed, after which a saccular incision and creation of a pocket flap will be made to expose the surgical area, after which the impacted wisdom tooth will be extracted. After that, the surgical area will be washed with 100 ml of normal saline, and in the next step, a piece of foam gel soaked in normal saline will be placed in the socket , then standard drug therapy with acetaminophen will be performed for patients every 6 hours. The normal saline used in this study will be manufactured by Samen Pharmaceutical Company, Mashhad, Iran. Yes - There is a plan to make this available What will be shared: The data are backed up in a master file on the Lorestan University server. This file is password-protected and is only accessible to the researchers named in the Human Research Ethics Committee approvals. After the project is completed, identifying data will be removed from the record. These records will be retained permanently to be used if the study is repeated with other drugs in the future. De-identified data may be made available to other researchers in the future to facilitate systematic reviews or meta-analyses. If such data are requested, they will only be made available after review and approval by the Human Research Ethics Committee. When: 6 Months After Publication of the Results To whom: Researchers Affiliated with Academic and Scientific Institutions Conditions: For the Completion of Research in the Same Field Where to obtain: Zahra.joudakii@gmail.com How to obtain: Request from the Human Research Ethics Committee unit of Lorestan University of Medical Sciences and approval from that unit Comments:
public Reza Nadripour
Eram Ave, West goldasht sector
Khorramabad Iran (Islamic Republic of) 6814785181 +98 916 363 1904 Zahra.joudakii@gmail.com Khoram-Abad University of Medical Sciences scientific Reza Nadripour
Eram Ave, West goldasht sector
Khorramabad Iran (Islamic Republic of) 6814785181 +98 916 363 1904 Zahra.joudakii@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 25 years With Impacted third Mandibular Molars Without Pericoronitis or Infection Who are not Pregnant Have no life-threatening Systemic Disease No Allergy to the Drugs used in the Study No recent use of Antibiotics or Anti-inflammatory Drugs Who are willing to participate in the Study 18 years 25 years Both Those whose Follow-up for recording Pain and Swelling was not possible Who were unwilling to continue in the Study Individuals whose Healing process was not normal Patients who used other Anti-inflammatory Drugs or Antibiotics after Surgery Whose Impacted third Molars were located close to the Nerve Canal Prevention Prevention Intervention group: local anesthetic injection of inferior alveolar and long buccal nerve block with 2% lidocaine carpol containing epinephrine at 80000:1 will be performed, after which a sulcular incision and creation of a pocket flap will be made to expose the surgical area, and then the impacted wisdom tooth will be extracted. After that, the surgical area will be washed with 100 ml of normal saline, and in the next step, a piece of foam gel is soaked with 4 mg of dexamethasone manufactured by Iran Hormone Pharmaceutical Company and placed in the dental socket, and finally, it will be performed with a 04 nylon suture, then standard drug therapy with acetaminophen will be performed every 6 hours. Control group: for patients, local anesthesia injection of inferior alveolar and long buccal nerve block with 2% lidocaine carpol containing epinephrine at 80000:1 will be performed, after which a saccular incision and creation of a pocket flap will be made to expose the surgical area, after which the impacted wisdom tooth will be extracted. After that, the surgical area will be washed with 100 ml of normal saline, and in the next step, a piece of foam gel soaked in normal saline will be placed in the socket , then standard drug therapy with acetaminophen will be performed for patients every 6 hours. The normal saline used in this study will be manufactured by Samen Pharmaceutical Company, Mashhad, Iran. Pain severity. Timepoint: The 2nd, 4th, and 7th Days After Surgery. Method of measurement: The Visual Analogue Scale will be used to measure the severity of patients' pain. The patient will be given a ten-centimeter ruler, numbered from 0 to 10, and the patient must indicate the level of pain on it on the second, fourth, and seventh days. Facial swelling. Timepoint: The 2nd, 4th, and 7th days after surgery. Method of measurement: To measure swelling, we measure from the outer canthus of the eye to the mandibular protuberance, from the middle of the tragus of the ear to the outer corner of the lip on the same side in millimeter. Trismus severity. Timepoint: The 2nd, 4th, and 7th days after surgery. Method of measurement: We measure the distance between the edges of the upper and lower incisors in millimeters. Khoram-Abad University of Medical Sciences Approved 2025-10-06 Lorestan University of Medical Sciences Ethics Committee Eram Ave, west Goldasht sector Khorram abad Lorestan Iran (Islamic Republic of)