Comparative Assessment of Preoperative Versus Postoperative Submucosal Dexamethasone on Postoperative Complications Following Surgical Extraction of Mandibular Third Molar: Randomized Controlled Trial

NCT06160180 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IRC/2508/023
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to compare the pain, edema and trismus of pre-operative versus post-operative submucosal dexamethasone in lower third molar surgical extraction done in healthy population.This is comparative study, will be conducted in patient indicated for surgical extraction of mandibular third molar at the department of oral and maxillofacial surgery, college of dental surgery, BPKIHS, Nepal. Verbal and written informed consent will be taken. Participants meeting inclusion criteria will be included in the study and will be divided into two groups, group A(pre-operative submucosal 2ml of 4mg/ml dexamethasone will be administered prior to placing an incision in buccal vestibule) and groupB(post-operative submucosal 2ml of 4mg/ml dexamethasone will be administered soon after closure of the incision site).Baseline measurement of interincisal distance for mouth opening, distance between the tragus to corner of mouth, gonion to corner of mouth and outer canthus to gonion as baseline for edema taken prior extraction. Extraction is carried out using standard protocol and postoperative antibiotics and analgesics are given. Rescue analgesic tramadol is prescribed and asked to be taken only pain score exceeds 7.Patient is kept on follow up for 2nd, 5th and 7th days and assessment of pain using numeric visual analogue scale, swelling using facial and trismus using interincial measurements and recorded. Any adverse effect of drugs will be recorded. The data collected will be entered in Microsoft excel sheet. It will then be transferred into SPSS(Statistical package for Social Sciences) for statistical analysis.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (3)

• PAIN MEASUREMENT POSTOPERATIVELY AFTER SURGICAL EXTRACTION OF 3RD MOLAR

  Pain will be calculated through Visual analogue Scale with 1 being least painful and 10 being most painful. Each patient fter extraction will be instructed for follow up in 2nd 5th and 7th postoperative days and asked to give value for the pain they experienced. Number of analgesics consumed was also counted from 2nd postoperative day to 7th postoperative day and will be recorded in written logbook. Number of resucue analgesics: if in case of severe pain not relieved by prescribed analgesic(Tab paracetamol+ ibuprofen), Cap tramadol is prescribed if necessary and was recorded in each postoperative days and written in the log book.

  SECOND, FIFTH AND SEVENTH POST OPERATIVE DAY

• SWELING

  facial measurements through graduated measuring tape in centimeters (outer canthus to gonion, tragus of ear to corner of mouth and corner of mouth to gonion

  BASELINE,SECOND, FIFTH AND SEVENTH POSTOPERATIVE DAY

• TRISMUS

  MEASURING NON-FORCED INTERINCISAL DISTANCE THROUGH STANDARD MEASURING SCALE IN MILIMETERS

  BASELINE,SECOND, FIFTH AND SEVENTH POSTOPERATIVE DAY

Study Arms (2)

Drug arm preoperative

ACTIVE COMPARATOR

Injection 2ml of 4mg dexamethasone loaded and deposited submucosally in the buccal vestibule of the extraction site after local anesthesia but before placement of the first incision.

Drug: Dexamethasone

Drug arm postoperative

ACTIVE COMPARATOR

Injection 2ml of 4mg dexamethasone loaded and deposited submucosallyin the buccal vestibule of the extraction site after finishing extraction and placement of last suture.

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Submucosal application

Also known as: treatment

Drug arm postoperative; Drug arm preoperative

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Clinically healthy patients (American Society of Anesthesiology I) with impacted lower third molar.
• Age ≥18 to ≤ 55 years
• No history of previous pericoronitis

You may not qualify if:

• Patients who are ASA II to ASA VI.
• Patients already on corticosteriods through any route.
• Patients with known allergy to any drugs.
• Pregnant and lactating females
• Patient not consenting to participate in the study

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Related Publications (7)

• Lau AAL, De Silva RK, Thomson M, De Silva H, Tong D. Third Molar Surgery Outcomes: A Randomized Clinical Trial Comparing Submucosal and Intravenous Dexamethasone. J Oral Maxillofac Surg. 2021 Feb;79(2):295-304. doi: 10.1016/j.joms.2020.09.020. Epub 2020 Sep 17.

  PMID: 33058774 BACKGROUND

• Saravanan K, Kannan R, John RR, Nantha Kumar C. A Single Pre Operative Dose of Sub Mucosal Dexamethasone is Effective in Improving Post Operative Quality of Life in the Surgical Management of Impacted Third Molars: A Comparative Randomised Prospective Study. J Maxillofac Oral Surg. 2016 Mar;15(1):67-71. doi: 10.1007/s12663-015-0795-0. Epub 2015 May 26.

  PMID: 26929555 BACKGROUND

• Al-Shamiri HM, Shawky M, Hassanein N. Comparative Assessment of Preoperative versus Postoperative Dexamethasone on Postoperative Complications following Lower Third Molar Surgical Extraction. Int J Dent. 2017;2017:1350375. doi: 10.1155/2017/1350375. Epub 2017 Apr 10.

  PMID: 28487738 BACKGROUND

• Deo SP. Effect of submucosal injection of dexamethasone on post-operative sequelae of third molar surgery. JNMA J Nepal Med Assoc. 2011 Apr-Jun;51(182):72-8.

  PMID: 22916516 BACKGROUND

• Majid OW, Mahmood WK. Effect of submucosal and intramuscular dexamethasone on postoperative sequelae after third molar surgery: comparative study. Br J Oral Maxillofac Surg. 2011 Dec;49(8):647-52. doi: 10.1016/j.bjoms.2010.09.021. Epub 2010 Oct 29.

  PMID: 21035237 BACKGROUND

• Bhargava D, Sreekumar K, Deshpande A. Effects of intra-space injection of Twin mix versus intraoral-submucosal, intramuscular, intravenous and per-oral administration of dexamethasone on post-operative sequelae after mandibular impacted third molar surgery: a preliminary clinical comparative study. Oral Maxillofac Surg. 2014 Sep;18(3):293-6. doi: 10.1007/s10006-013-0412-7. Epub 2013 Mar 20.

  PMID: 23512235 BACKGROUND

• Almeida RAC, Lemos CAA, de Moraes SLD, Pellizzer EP, Vasconcelos BC. Efficacy of corticosteroids versus placebo in impacted third molar surgery: systematic review and meta-analysis of randomized controlled trials. Int J Oral Maxillofac Surg. 2019 Jan;48(1):118-131. doi: 10.1016/j.ijom.2018.05.023. Epub 2018 Jun 23.

  PMID: 29941229 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone; Therapeutics

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Shristi Maharjan, MDS

CONTACT

9841981841; shreemaharjan93@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: August 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08