Investigating the Effect of Topical Dexamethasone in Alveolar Socket on Pain and Complications After Impacted third molar Tooth Surgery: Clinical trial

Evaluation of the Effect of Local Dexamethasone in the Tooth Socket on the Reduction of Pain and Postoperative Complications Following Surgical Removal of Impacted Mandibular Third Molars

A randomized, double-blind, parallel, controlled clinical trial (Phase 3) conducted on 52 Patients.

Patients attending Baset Clinic in Khorramabad during the second half of 1404 will be randomly assigned to Intervention and Control Groups, with Permuted Block Randomization used within each Stratum. Both Patients and Evaluators are blinded, and the Code Breaker is a person external to the Research Team. After Surgery, a piece of Gel Foam containing 4 mg of Dexamethasone will be placed into the Tooth Socket in the Intervention Group and Sutured with 4-0 Nylon. In the Control Group, a Gel Foam soaked in Normal Saline will be placed in the Socket.

Inclusion Criteria: Patients aged 18 to 25 years without infection, who are not pregnant and do not have any life-threatening systemic diseases, without drug allergies to the medications used in the study, or recent use of antibiotics or anti-inflammatory drugs. Exclusion Criteria: Patients who cannot be followed up, whose healing process does not proceed normally, who use other anti-inflammatory or antibiotic drugs after surgery, or cases where the tooth of interest is close to the nerve canal.

After the Surgical Extraction of the Impacted Third Molar and irrigation, a piece of Gel Foam impregnated with 4 mg of Dexamethasone will be placed into the Tooth Socket in the Intervention Group, followed by Suturing with 4-0 Nylon. In the Control Group, a piece of Gel Foam soaked in Normal Saline will be placed in the Socket.

Postoperative pain intensity; Postoperative swelling; Postoperative trismus

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.

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.

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.

6 Months After Publication of the Results

Researchers Affiliated with Academic and Scientific Institutions

For the Completion of Research in the Same Field

Zahra.joudakii@gmail.com

Request from the Human Research Ethics Committee unit of Lorestan University of Medical Sciences and approval from that unit