The Effect of Dexamethasone Submucosal Injection After Surgical Extraction of Lower Impacted Third Molars on Trismus and Edema

NCT06953440 | Recruiting Phase 4 DMC

• 1 other identifier: 225-11-23
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to investigate whether dexamethasone decreases edema and trismus in adults undergoing lower third molar surgical extraction. The main question it aims to answer is: Does dexamethasone submucosal injection have a positive impact on trismus and edema after third molar surgery compared to conventional postoperative prescription? Participants will:

• Be administered with dexamethasone submucosal injection or a placebo after the surgery.
• Visit the clinic three times the week after the extraction for follow-up.

Conditions

Swelling/ Edema; Trismus

Keywords

Extraction; third molar; wisdom teeth; dexamethasone; steroids; submucosal

Outcome Measures

Primary Outcomes (1)

• Trismus and Swelling

  Baseline and follow-up measurements will be measured by a standardized ruler. At the first visit, interincisal distance will be recorded in millimeters to measure trismus. Distance from the angle of the mandible to the outer canthus of the eye, distance from the tragus of the ear to the corner of the mouth, and distance from the tragus of the ear to soft tissue pogonion will be recorded in millimeters and their mean will be calculated to measure edema. Pell and Gregory classification of the tooth and impaction angulation will be recorded. Facial symmetry and whether the angle of the mandible is palpable or not will be recorded as well. At the 2nd, 4th, and 7th visits, interincisal distance will be recorded in millimeters to measure trismus. Distance from the angle of the mandible to the outer canthus of the eye, distance from the tragus of the ear to the corner of the mouth, and distance from the tragus of the ear to soft tissue pogonion will be recorded in millimeters

  From the day of extraction, the 2nd day of surgery, 4th day, and 7th day of surgery.

Secondary Outcomes (4)

• Social Interaction

  Patients will be followed up in the 2nd, 4th, and 7th postoperative days.

• Work Ability

  Patients will be followed up in the 2nd, 4th, and 7th postoperative days.

• Eating Ability

  Patients will be followed up in the 2nd, 4th, and 7th postoperative days.

• Sleep Impairment

  Patients will be followed up in the 2nd, 4th, and 7th postoperative days.

Study Arms (2)

Dexamethasone Group

EXPERIMENTAL

Patient received 4 milligrams of dexamethasone

Drug: Dexamethasone Sodium Phosphate Injection

Control Group

PLACEBO COMPARATOR

Patient received 4 milligrams of normal saline solution

Other: Normal Saline (Placebo)

Interventions

Dexamethasone Sodium Phosphate Injection DRUG

Patients will receive 4 milligrams of dexamethasone submucosal injection next to the extraction site.

Dexamethasone Group

Normal Saline (Placebo) OTHER

Patients will receive 4 milligrams of normal saline solution next to the extraction site.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with impacted lower third molars requiring surgical extraction.
• Adults over the age of 18 years old.
• American Society of Anaesthesiologists (ASA) 1, and ASA 2

You may not qualify if:

• Patients with preoperative intraoral or extraoral swelling.
• Patients requiring simple extraction (Class I group A according to Pell and ---Gregory classification).
• Patients with uncontrolled systemic disease such as uncontrolled diabetic - patients.
• Patients who are allergic to corticosteroids.
• Patients who are contraindicated to use corticosteroids such as uncontrolled diabetic patients, and osteoporotic patients.
• Patients who require extraction of additional teeth at the same visit.

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University, Faculty of Dentistry

Jeddah, Mecca Region, Saudi Arabia

RECRUITING

Related Publications (9)

• Hou C, Liu F, Liu C. Comparison of Submucosal With Intramuscular or Intravenous Administration of Dexamethasone for Third Molar Surgeries: A Systematic Review and Meta-Analysis. Front Surg. 2021 Aug 10;8:714950. doi: 10.3389/fsurg.2021.714950. eCollection 2021.

  PMID: 34447785 BACKGROUND

• Grossi GB, Maiorana C, Garramone RA, Borgonovo A, Beretta M, Farronato D, Santoro F. Effect of submucosal injection of dexamethasone on postoperative discomfort after third molar surgery: a prospective study. J Oral Maxillofac Surg. 2007 Nov;65(11):2218-26. doi: 10.1016/j.joms.2006.11.036.

  PMID: 17954317 BACKGROUND

• Wanithanont P, Chaiyasamut T, Vongsavan K, Bhattarai BP, Pairuchvej V, Kiattavorncharoen S, Wongsirichat N. Comparative efficiency of the preoperative pterygomandibular space injection of two doses of dexamethasone in mandibular third molar surgery. J Dent Anesth Pain Med. 2021 Feb;21(1):29-39. doi: 10.17245/jdapm.2021.21.1.29. Epub 2021 Jan 29.

  PMID: 33585682 BACKGROUND

• Warraich R, Faisal M, Rana M, Shaheen A, Gellrich NC, Rana M. Evaluation of postoperative discomfort following third molar surgery using submucosal dexamethasone - a randomized observer blind prospective study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Jul;116(1):16-22. doi: 10.1016/j.oooo.2012.12.007. Epub 2013 Feb 28.

  PMID: 23453611 BACKGROUND

• Mojsa IM, Pokrowiecki R, Lipczynski K, Czerwonka D, Szczeklik K, Zaleska M. Effect of submucosal dexamethasone injection on postoperative pain, oedema, and trismus following mandibular third molar surgery: a prospective, randomized, double-blind clinical trial. Int J Oral Maxillofac Surg. 2017 Apr;46(4):524-530. doi: 10.1016/j.ijom.2016.11.006. Epub 2016 Dec 21.

  PMID: 28012633 BACKGROUND

• Parhizkar P, Schmidlin PR, Bornstein MM, Fakheran O. Can adjunctive corticosteroid therapy improve patient-centered outcomes following third molar surgery? A systematic review. Med Oral Patol Oral Cir Bucal. 2022 Sep 1;27(5):e410-e418. doi: 10.4317/medoral.25177.

  PMID: 35975802 BACKGROUND

• Moraschini V, Hidalgo R, Porto Barboza Ed. Effect of submucosal injection of dexamethasone after third molar surgery: a meta-analysis of randomized controlled trials. Int J Oral Maxillofac Surg. 2016 Feb;45(2):232-40. doi: 10.1016/j.ijom.2015.09.008. Epub 2015 Oct 14.

  PMID: 26458538 BACKGROUND

• Kiencalo A, Jamka-Kasprzyk M, Panas M, Wyszynska-Pawelec G. Analysis of complications after the removal of 339 third molars. Dent Med Probl. 2021 Jan-Mar;58(1):75-80. doi: 10.17219/dmp/127028.

  PMID: 33789003 BACKGROUND

• Aljafar A, Alibrahim H, Alahmed A, AbuAli A, Nazir M, Alakel A, Almas K. Reasons for Permanent Teeth Extractions and Related Factors among Adult Patients in the Eastern Province of Saudi Arabia. ScientificWorldJournal. 2021 Feb 22;2021:5534455. doi: 10.1155/2021/5534455. eCollection 2021.

  PMID: 33688305 BACKGROUND

Related Links

• Google drive link that contains all information regarding the study

MeSH Terms

Conditions

Edema; Trismus

Interventions

dexamethasone 21-phosphate; Saline Solution

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Lojain Bassyoni, BDS, MSc, FRCDC

CONTACT

00966504623553; lbassyoni@kau.edu.sa

Razan Baabdullah, BDS, MSc, FRCDC

CONTACT

00966555015167; rmsbaabdullah@kau.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: To ensure that the patient and OMFS resident were blinded in this study, the corticosteroid and placebo injections were of the same color and size, were stored in similar syringes, and were coded as drug 1 or drug 2. The OMFS resident received the syringe corresponding to the patient's random allocation prior to the beginning of the procedure. The number of the drug was recorded in the patient file. Then, the drug was administered in the buccal vestibule next to the site of extraction after surgery. Thus, the patient, surgeon, and the person responsible for the assessments of swelling and trismus were masked to the type of medication used during each surgical procedure. The drugs used in the different surgeries were only revealed after the acquisition and analysis of all data.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral and Maxillofacial Surgery Consultant and Assistant Professor

Model Details: There will be two groups. The test group will receive 4mg/1ml dexamethasone submucosal injection at the buccal vestibule next to the surgical site. The control group will receive 1 ml of normal saline injection in the buccal vestibule next to the surgical site. The primary objective of this study is to compare mean change in trismus and mean edema between 2 independent groups.

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: May 1, 2025
• Study Start: February 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)