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IRCT20260629070000N1 IRCT 2026-07-11 Zanjan University of Medical Sciences Effect of Dexamethasone in Wisdom Tooth Surgery Evaluation of the Effect of Dexamethasone-Impregnated Gelfoam Placement in the Socket on Postoperative Pain Following Impacted Mandibular Third Molar Surgery 2026-08-01 anticipated 35 Pending https://irct.ir/trial/91251 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Randomization description: In this randomized clinical trial with a Split-Mouth design, a randomization method using a table of random numbers is employed to eliminate confounding effects related to the "surgical side" (right or left) and the "surgical sequence" (first or second operation). After eligible patients are selected, a randomization list is prepared by an individual independent of the study (e.g., a statistician). This list randomly determines which side of the jaw (right or left) will undergo surgery in the first session and which side will receive the main intervention (Gelfoam impregnated with dexamethasone) and which side will receive the control intervention (Gelfoam impregnated with normal saline). In other words, each patient acts as their own control, and both the order of surgery and the type of intervention for each side are determined randomly. An example of the random number table method is as follows: Suppose there are two study groups (A and B) and six participants who need to be randomly allocated. One row of a random number table is selected arbitrarily, where each number ranges from 0 to 9. Numbers 0–4 are assigned to Group A, and numbers 5–9 are assigned to Group B. Assume the selected row contains the following sequence: 0, 5, 2, 7, 8, 4. Accordingly, the number 0 is allocated to Group A, 5 to Group B, 2 to Group A, and so on. Therefore, the first participant is assigned to Group A, the second to Group B, the third to Group A, the fourth to Group B, the fifth to Group B, and the sixth to Group A, Blinding description: In this study, blinding is performed as a double-blind design. The patient (participant) and the outcome assessor (the individual measuring pain intensity using the VAS scale during follow-up days) are unaware of the type of intervention (dexamethasone or normal saline) received in each surgical side. However, the surgeon (performing the operation) is aware of the treatment allocation due to the nature of the intervention (impregnating the Gelfoam with the drug or saline during surgery); therefore, blinding of the surgeon is not feasible. In other words, the patient and the outcome assessor are blinded to the treatment allocation (double-blind). 3 Impacted third molar. Intervention 1: Intervention group:Intervention group: placement of a 1×1 cm piece of absorbable gelatin sponge (Gelfoam, Spongostan, Denmark) impregnated with 8 mg dexamethasone (8 mg vial, Caspian, Iran) dissolved in 2 ml normal saline into the tooth socket after extraction of impacted mandibular third molar. The socket is then closed with 3-0 silk suture. Both groups receive standard antibiotic (amoxicillin 500 mg every 8 hours) and oral analgesic (ibuprofen 400 mg as needed for pain). Intervention 2: Control group: placement of a 1×1 cm piece of absorbable gelatin sponge (Gelfoam, Spongostan, Denmark) impregnated with 2 ml normal saline (without drug) into the tooth socket after extraction of impacted mandibular third molar. The socket is then closed with 3-0 silk suture. Both groups receive standard antibiotic (amoxicillin 500 mg every 8 hours) and oral analgesic (ibuprofen 400 mg as needed for pain). No - There is not a plan to make this available Justification or reason for not sharing IPD is This is a general dentistry thesis with a limited sample size (35 patients) and a Split-mouth design. The data contains identifiable patient information. Due to confidentiality concerns and lack of appropriate infrastructure for data sharing at this level, there is no plan to share individual participant data. Furthermore, the study is funded by personal resources of the investigators, and no budget has been allocated for data preparation and sharing.
public Mohammad Hossein Asadi
Central Campus of Zanjan University of Medical Sciences, Sobuti Blvd., Zanjan, Iran - Dental School
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3315 6144 hosseinomfs@gmail.com Zanjan University of Medical Sciences scientific Mohammad Hossein Asadi
Central Campus of Zanjan University of Medical Sciences, Sobuti Blvd., Zanjan, Iran - Dental School
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3315 6144 hosseinomfs@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 18 and 35 years. Presence of bilaterally impacted mandibular third molars with similar impaction position (according to the Pell and Gregory classification) to ensure matching. American Society of Anesthesiologists (ASA) Physical Status I (healthy patients with no systemic disease). Willingness to cooperate and complete the follow-up visits in both surgical sessions. 18 years 30 years Both History of cigarette smoking or alcohol consumption (due to their negative effects on wound healing and increased risk of dry socket). (based on the patient's dental record and medical history) Pregnancy or breastfeeding. History of hypersensitivity to dexamethasone, Gelfoam, or local anesthetic agents. (based on the patient's dental record and medical history) Presence of active infection (e.g., pericoronitis) or any lesion at the surgical site. (based on clinical examination before surgery) Use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids within 7 days before surgery. Development of dry socket after surgery (the participant will be withdrawn from the study and receive standard treatment immediately). K01.1 Impacted teeth Treatment - Drugs Placebo Intervention group:Intervention group: placement of a 1×1 cm piece of absorbable gelatin sponge (Gelfoam, Spongostan, Denmark) impregnated with 8 mg dexamethasone (8 mg vial, Caspian, Iran) dissolved in 2 ml normal saline into the tooth socket after extraction of impacted mandibular third molar. The socket is then closed with 3-0 silk suture. Both groups receive standard antibiotic (amoxicillin 500 mg every 8 hours) and oral analgesic (ibuprofen 400 mg as needed for pain). Control group: placement of a 1×1 cm piece of absorbable gelatin sponge (Gelfoam, Spongostan, Denmark) impregnated with 2 ml normal saline (without drug) into the tooth socket after extraction of impacted mandibular third molar. The socket is then closed with 3-0 silk suture. Both groups receive standard antibiotic (amoxicillin 500 mg every 8 hours) and oral analgesic (ibuprofen 400 mg as needed for pain). Postoperative pain intensity. Timepoint: Day 1, day 3, and day 7 after each surgical session. Method of measurement: Visual Analogue Scale (VAS), which is a 10-centimeter line ranging from 0 (no pain) to 10 (worst imaginable pain), and the patient marks their pain intensity on it. Number of analgesics consumed. Timepoint: First week after each surgical session. Method of measurement: Daily questioning of the patient about the number of analgesic tablets consumed in the past 24 hours and recording it on a designated form. Zanjan University of Medical Sciences Approved 2026-06-16 Ethics Committee of Zanjan University of Medical Sciences Central Campus of Zanjan University of Medical Sciences, Sobuti Blvd., Zanjan, Iran Zanjan Zanjan Iran (Islamic Republic of)