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

November 29, 2023 updated by: Dr Shristi Maharjan, B.P. Koirala Institute of Health Sciences

Randomized Controlled Trial on Assessment of Preoperative Versus Postoperative Submucosal Dexamethasone On Postoperative Complications Following Surgical Extraction Of Mandibular Third Molar.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction:Third molar impaction is a chronic disorder that often necessitates tooth extraction. Impaction is characterized as the inability of a tooth to erupt at its proper location in the dental arch during its usual growth time.The surgical extraction of lower third molars is the most frequent intervention in oral surgery. This procedure is often associated with significant postsurgical sequelae that may have both biological and social impact. Besides severe complications such as dysaesthesia, severe infection, fracture, and dry socket, patients frequently complain of pain, swelling, and limitation in mouth opening (Trismus) throughout the postoperative course due to the inflammatory response following the surgical injury. To control postoperative inflammation and symptoms associated, it is necessary to provide an adequate anti-inflammatory therapy and various medications have been prescribed for the same. For several decades surgeons administered corticosteroids before or just after third molars' surgery to reduce inflammation and associated symptoms after oral surgery. Corticosteroids mechanism of action is the inhibition of the enzyme Phospholipase A2 (PLA 2), which reduces the release of arachidonic acid in the cells of the inflamed area.This will decrease prostaglandins and leukotriene synthesis; therefore reducing the accumulation of neutrophils has been the greatest advantage of corticosteroids compared to non-steroidal anti-inflammatory drugs. The aim of this study was to evaluate the effect of preoperative versus postoperative administration of submucosal Dexamethasone on postoperative discomfort including pain, edema, and trismus following lower third molar surgery in order to allow a better welfare of the patient and to return the patient to the normal activity following the surgery. And to determine the efficacy of single dose 2 ml/8 mg submucosal dexamethasone injection in the buccal vestibule in proximity to the surgical site.

Rational:Pain and edema are the most frequent postoperative sequelae to surgical removal of impacted teeth, all of which are due to the local inflammatory response. The inflammation induced by tissue damage is the primary cause of acute postoperative pain after third molar extraction. Edema after third molar surgery is caused by extravasation of fluid by traumatized tissues as a consequence of the disruption or obstruction of lymph arteries, culminating in the termination of lymph drainage, which accumulates in the tissues. Adjunctive use of corticosteroids to decrease tissue mediators of inflammation and reduce fluid transudation and edema is common in surgical procedures. Corticosteroids inhibits the enzyme Phospholipase A2 (PLA 2), which reduces the release of arachidonic acid in the cells of the inflamed area.Dexamethasone has higher potency, lower sodium retaining ability and longer half-life. Long-acting steroids outperform short-acting steroids, and submucosal steroid administration has similar consequences as intravenous and intramuscular routes. Also rate of absorption is highly dependent on the blood flow to the site.Submucosal dexamethasone is quite simple, less invasive, painless, convenient for the surgeon and the patient and offers a low cost solution for the typical discomfort associated with the extraction of impacted lower third molar. Also,submucosal injection offers advantage of concentrating the drug near the surgical area with less systemic absorption and no further manipulation of the tissues.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Drug arm preoperative
receiving pre-operative submucosal dexamethasone 2ml of 4mg/ml solution into buccal vestibule prior to the incision.
Drug: Dexamethasone
Submucosal application
Other Names:
  • treatment
Active Comparator: Drug arm postoperative
receiving immediately post-operative submucosal dexamethasone 2ml of 4mg/ml solution in the buccal vestibule after placement of last suture.
Drug: Dexamethasone
Submucosal application
Other Names:
  • treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PAIN MEASUREMENT POSTOPERATIVELY AFTER SURGICAL EXTRACTION OF 3RD MOLAR
Time Frame: BASELINE, SECOND, FIFTH AND SEVENTH POST OPERATIVE DAY
USING NUMERIC PAIN SCORE, 1 BEING LEAST PAINFUL AND 10 BEING WORST PAIN.
BASELINE, SECOND, FIFTH AND SEVENTH POST OPERATIVE DAY
SWELING
Time Frame: BASELINE,SECOND, FIFTH AND SEVENTH POSTOPERATIVE DAY
facial measurements (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
Time Frame: BASELINE,SECOND, FIFTH AND SEVENTH POSTOPERATIVE DAY
MEASURING NON-FORCED INTERINCISAL DISTANCE
BASELINE,SECOND, FIFTH AND SEVENTH POSTOPERATIVE DAY

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B.P. Koirala Institute of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Actual)

December 7, 2023

Study Record Updates

Last Update Posted (Actual)

December 7, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRC/2508/023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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