Intraosseous Versus Submucosal Dexamethsone Injection in Third Molar Surgery

December 9, 2024 updated by: Mahreen Mahmood, Services Institute of Medical Sciences, Pakistan

Efficacy of Intraosseous Versus Submucosal Dexamethasone Injection in Terms of Pain, Facial Swelling and Interincisal Opening Among Patients Undergoing Third Molar Surgery

The goal of this clinical trial is to learn if intraosseous dexamethasone injection is better for pain and swelling postop 3rd molar surgery than submucosal dexamethasone injection. The main questions it aims to answer are:

Does intraosseous dexamethasone injection provide better pain relief and lessen facial swelling than submucosal dexamethasone injection Does intraosseous dexamethasone injection provide better interincisal opening than submucosal dexamethasone injection Researcher will compare both the techniques to see if intraosseous dexamethasone injection works better than submucosal dexamethasone injection

Participants will:

Be assessed at 3rd and 7th day postoperatively Pain will be assessed through visual analog scale score Facial measurement will be calculated as horizontal measurement plus vertical measurement divided by 2, where horizontal measurement will be taken as the distance between corner of the mouth and the earlobe attachment, and vertical measurement will be taken as distance from outer canthus of the eye to the angle of jaw.

Interincisal opening will be measured from the incisal edge of the maxillary central incisors to the incisal edge of mandibular central incisors at the midline by using millimeter ruler

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVE: To determine the efficacy of intraosseous versus submucosal dexamethasone injection in terms of pain, facial swelling and interincisal opening among patients undergoing mandibular 3rd molar surgery OPERATIONAL DEFINITIONS

Mandibular third molar:

A mandibular third molar prevented from erupting into position because of malposition or lack of space will be assessed on clinical (visual examination in oral cavity) and radiographical examination (periapical and/or orthopantomogram) by using Pell and Gregory classification method and modified Winter's classification method

Efficacy:

Efficacy of intraosseous and submucosal dexamethasone will be assessed in terms of lower VAS pain score, less facial swelling, and greater interincisal distance.

Pain:

Pain is an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage. Pain will be assessed using visual analogue scale (VAS), which is a self-administered continuous scale comprised of a line of 10 cm in length, anchored by "no pain (score 0)" and "pain as bad as it could be (score 10)". The patient is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity; and score is determined by measuring the distance between "no pain (score 0)" anchor and the patient's mark. A higher score indicates greater pain intensity

Interincisal opening:

Interincisal opening will be measured from the incisal edge of the maxillary central incisors to the incisal edge of mandibular central incisors at the midline by using millimeter ruler.

Facial swelling:

Facial swelling is the buildup of fluid in the tissues of the face. Facial measurement will be calculated as horizontal measurement plus vertical measurement divided by 2, where horizontal measurement will be taken as the distance between corner of the mouth and the earlobe attachment, and vertical measurement will be taken as distance from outer canthus of the eye to the angle of jaw.

These measurements will be taken as baseline measurement before the procedure, and then on day 3 and 7 after procedure.

HYPOTHESIS:

Intraosseous dexamethasone is more efficacious in terms of pain control, less facial swelling and greater interincisal opening than submucosal dexamethasone among patients undergoing mandibular third molar surgery.

MATERIAL AND METHODS

STUDY DESIGN:

Randomized controlled trial (RCT)

SETTINGS:

Department of Oral & Maxillofacial Surgery, Services Institute of Medical Sciences, Lahore

DURATION OF STUDY:

Six months after approval of synopsis

SAMPLE SIZE:

A sample size of 76 (38 in each group) calculated using the expected mean difference of pain VAS 0.9 between intraosseous dexamethasone group (3.3±1.3) and submucosal dexamethasone group (2.4±1.1) with 95.0% confidence level and 90.0% power of test.

Formula n = (Zα/2+Zβ)2 * _2 σ2_ d2 Where Zα/2 = Critical value of the normal distribution = 1.96 for 95.0% Cl Zβ = Critical value of the normal distribution = 1.28 for 90.0% power of test σ2 = Population variance = 1.44 d = Difference = 0.9

SAMPLING TECHNIQUE:

Non-probability consecutive sampling technique

DATA COLLECTION PROCEDURE:

The study will be approved by the Institutional Ethics Review Committee of Services Institute of Medical Sciences Lahore. All eligible patients undergoing mandibular third molar surgery will be invited to participate in the study and informed consent will be obtained from all volunteer participants. Total 76 patients (38 in each group) will be randomized into two equal-size groups i.e. Group A and Group B by lottery method. A structured proforma will be used to collect demographic and clinical data.

Before surgery, age, gender, Pell & Gregory type, Winter's type, baseline interincisal opening and facial measurement will be noted. In Group A, patients will receive 4 mg dexamethasone intraosseous injection into the bone distal to the socket of impacted third molar immediately after extraction of the third molar and before suturing. In Group B, patients will receive 4 mg dexamethasone submucosal injection into the buccal vestibule opposite to the surgical site of impacted third molar immediately after surgery. A team of supervisor and researcher will perform all these procedures. All patients will be prescribed tablet naproxium sodium 550mg twice a day for two days.

Patients will be assessed for pain, interincisal opening and facial measurement at day 3 and 7 after surgery. As per operational definitions, efficacy in terms of lower pain VAS score, less facial swelling, and greater interincisal opening will be compared between intraosseous and submucosal dexamethasone groups.

DATA ANALYSIS PROCEDURE:

Statistical Package for Social Sciences (SPSS) version 27 will be used for data entry and analysis. The quantitative variables such as age, interincisal opening, facial measurement and pain VAS score will be reported using mean ± standard deviation. The qualitative variables such as gender, Pell & Gregory type, and Winter's type will be reported using number (percent). The comparison between intraosseous and submucosal dexamethasone groups for interincisal opening, facial measurement and pain VAS score will be performed by t-test. The data will be stratified for age and gender. After stratification comparison between intraosseous and submucosal dexamethasone groups for interincisal opening, facial measurement and pain VAS score will be performed by t-test. P-value of ≤0.05 will be considered as significant.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

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

Study Locations

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

No

Description

Inclusion Criteria:

  • Patients undergoing mandibular third molar surgery
  • Age 18 to 35 years
  • Male and female

Exclusion Criteria:

  • Uncontrolled systemic medical problems including diabetes and hypertension
  • Presence of any cyst, tumor, or other pathological condition in the molar area
  • Presence of any craniofacial anomalies, congenital deformities or syndromes
  • Patients with known adverse effects of steroid use
  • Previous history of orthodontic treatment
  • Have a pain disorder or taking pain medications
  • Pregnant and lactating mothers

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A will undergo intraosseous dexamethasone injection after 3rd molar surgery
In Group A, patients will receive 4 mg dexamethasone intraosseous injection into the bone distal to the socket of impacted third molar immediately after extraction of the third molar and before suturing
Procedure: Intraosseous dexamethasone injection after 3rd molar surgery
In Group A, patients will receive 4 mg dexamethasone intraosseous injection into the bone distal to the socket of impacted third molar immediately after extraction of the third molar and before suturing
Active Comparator: Group B will undergo submucosal dexamethasone injection after 3rd molar surgery
In Group B, patients will receive 4 mg dexamethasone submucosal injection into the buccal vestibule opposite to the surgical site of impacted third molar immediately after surgery.
Procedure: Submucosal dexamethasone injection after 3rd molar surgery
In Group B, patients will receive 4 mg dexamethasone submucosal injection into the buccal vestibule opposite to the surgical site of impacted third molar immediately after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 3rd and 7th day post operatively
Pain is an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage. Pain will be assessed using visual analogue scale (VAS), which is a self-administered continuous scale comprised of a line of 10 cm in length, anchored by "no pain (score 0)" and "pain as bad as it could be (score 10)". The patient is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity; and score is determined by measuring the distance between "no pain (score 0)" anchor and the patient's mark. A higher score indicates greater pain intensity
3rd and 7th day post operatively
Interincisal opening
Time Frame: 3rd and 7th day post operatively
Interincisal opening will be measured from the incisal edge of the maxillary central incisors to the incisal edge of mandibular central incisors at the midline by using millimeter ruler
3rd and 7th day post operatively
Facial swelling
Time Frame: 3rd and 7th day post operatively
Facial swelling is the buildup of fluid in the tissues of the face. Facial measurement will be calculated as horizontal measurement plus vertical measurement divided by 2, where horizontal measurement will be taken as the distance between corner of the mouth and the earlobe attachment, and vertical measurement will be taken as distance from outer canthus of the eye to the angle of jaw
3rd and 7th day post operatively

Collaborators and Investigators

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

Sponsor

Services Institute of Medical Sciences, Pakistan

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)

June 1, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Actual)

December 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1315-4156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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