Investigating the effect of dexamethasone by gelfoam carrier in preventing dry socket syndrome following surgical extraction of the impacted third molar of the mandible

The Effectiveness of Dexamethasone in Preventing Dry Socket Syndrome Following Mandibular Third Molar Surgery

A parallel, split-mouth, single-blind, randomized, phase 3 trial on 36 patients. The randomization will be performed using a sealed envelope containing a predetermined random sequence.

This study is a randomized controlled trial. Data are collected from a clinical trial involving patients referred to the Department of Maxillofacial Surgery at the Islamic Azad University Dental School during 2024–2025. In the intervention group, after irrigation of the surgical site, the cavity is filled with dexamethasone-impregnated foam gel and sutured. A sterile gauze pad is placed over the site for 30 minutes in both groups. Blinding is single-sided, with only the evaluator being blinded to group allocation.

Inclusion criteria: Age between 18 and 35 years, presence of bilateral impacted mandibular third molars Exclusion criteria: presence of uncontrolled systemic diseases

All patients will undergo mandibular third molar extraction performed by the same surgeon. A buccal flap with a distobuccal releasing incision and a sulcular incision extending to the mesial aspect of the second molar will be made. Following local anesthesia, the incision is performed, the flap is reflected, and a portion of the bone covering the tooth is removed using a surgical bur. After extracting the tooth, the surgical site is irrigated, and the socket is filled with a dexamethasone-containing foam gel. The flap is then repositioned and sutured using 3-0 Vicryl sutures with a 26 mm needle. A sterile gauze pad is placed over the surgical site for 30 minutes in both groups. All patients are prescribed amoxicillin 250 mg capsules every 8 hours and Gelofen 500 mg tablets every 6 hours.

Occurrence of dry socket

In this study, we used the restricted randomization method randomization (block randomization type) We will use randomization. Blocking is usually used in order to Creating a balance in the number of samples assigned to each of the groups be used for study. This feature helps researchers to Cases that require intermediate analyzes during the sampling process be the number of samples assigned to each of the case groups The study is equal. The size of all the blocks is equal and we are in this Single-group trial of 4 blocks (including 4 participants in We will have an intervention group and a control). The randomization tool is also from sequence generation software Random (random software allocation) is used that this Random sequence generation software is capable of simple randomization They are used to generate random sequences using the block method. To hide We use Concealment Allocation We use the method used to execute the sequence Randomization is applied to the participants in the study, in a way Before assigning the individual, the assigned group is not clear. With from sealed opaque envelopes with random sequence (envelopes opaque, sealed, numbered Sequentially (which in In this method, each random sequence is created on a card It is registered and the cards are placed in the envelopes in order become In order to preserve the random sequence on the outer surface of the envelope Numbering is done in the same order. Finally, the envelope door The letters are glued and placed in a box in order. At The time of starting the registration of participants, based on the order of entry of the company Eligible candidates to study, one of the letter envelopes in open order and the assigned group of that participant is revealed.

The evaluator is unaware of the type of intervention, and the study is conducted in a single-blind manner.