Evaluation of the Effect of Dexamethasone-Impregnated Gelfoam Placement in the Socket on Postoperative Pain Following Impacted Mandibular Third Molar Surgery

To determine the effect of placing dexamethasone-impregnated Gelfoam in the socket on reducing postoperative pain following impacted mandibular third molar surgery, and to compare pain intensity between the intervention and control sides.

A randomized double-blind clinical trial with a Split-mouth design on 35 patients (70 samples), each patient serving as their own control. Randomization using a table of random numbers determines the surgical side and intervention type. The patient and outcome assessor are blinded to the intervention, while the surgeon is aware.

This study is conducted at the Department of Oral and Maxillofacial Surgery, Dental School, and Shafieh Specialized Clinic of Zanjan University of Medical Sciences. After screening and obtaining informed consent, patients are randomized and standard surgery is performed by a single surgeon. In each session, the respective Gelfoam is placed in the socket and the wound is closed. The contra

Inclusion criteria: age 18-30 years; bilateral symmetrical impacted third molars; complete systemic health (ASA I); willingness to cooperate. Exclusion criteria: uncontrolled systemic disease; smoking/alcohol; pregnancy/breastfeeding; hypersensitivity to dexamethasone, Gelfoam or anesthetics; active infection at surgical site; NSAIDs/corticosteroids within 7 days; dry socket after surgery.

Intervention group: placement of Gelfoam impregnated with 8 mg dexamethasone (dissolved in 2 ml normal saline) in the tooth socket after extraction of impacted third molar. Control group: placement of Gelfoam impregnated with 2 ml normal saline in the socket. Both groups receive standard antibiotic and oral analgesic.

Pain intensity by VAS on days 1,3,7 post-surgery

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.

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).

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.