The Effect of Dexamethasone Submucosal Injection After Surgical Extraction of Lower Impacted Third Molars on Trismus and Edema
NCT ID: NCT06953440
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
66 participants
INTERVENTIONAL
2024-02-01
2025-06-30
Brief Summary
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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.
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Detailed Description
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To ensure that the patient and OMFS resident are blinded in this study, the corticosteroid and placebo injections are of the same color and size, are stored in similar bottles, and are coded as drug 1 or drug 2. Additionally, they will be placed in sealed envelopes by a dental assistant.
The OMFS resident will withdraw an envelope randomly. The number is recorded in the patient file. Then, the drug will be 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 are masked to the type of medication used during each surgical procedure. The drugs used in the different surgeries are only revealed after the acquisition and analysis of all data. Baseline and follow-up measurements will be measured by a standardized ruler. At the first visit, interincisal distance will be recorded 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 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. The number of drug that was given to the patient will be recorded.
At the 2nd, 4th, and 7th visits, interincisal distance will be recorded 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 to measure edema. Facial symmetry and whether the angle of the mandible is palpable or not will be recorded. Whether the patient is able to interact socially or not. If not, was it due to edema, feeling sick, or bad mood. The patient's ability to work, the patient\'s ability to eat the food he is used to eating, and the presence of sleep impairment will be recorded as well.
Surgery will be done by calibrated OMFS residents. After the surgery, the surgeon will use the preassigned randomly picked envelope and administer it in the buccal vestibule next to the surgical site. Patients will be followed up in the 2nd, 4th, and 7th postoperative days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
The primary objective of this study is to compare mean change in trismus and mean edema between 2 independent groups.
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Dexamethasone Group
Patient received 4 milligrams of dexamethasone
Dexamethasone Sodium Phosphate Injection
Patients will receive 4 milligrams of dexamethasone submucosal injection next to the extraction site.
Control Group
Patient received 4 milligrams of normal saline solution
Normal Saline (Placebo)
Patients will receive 4 milligrams of normal saline solution next to the extraction site.
Interventions
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Dexamethasone Sodium Phosphate Injection
Patients will receive 4 milligrams of dexamethasone submucosal injection next to the extraction site.
Normal Saline (Placebo)
Patients will receive 4 milligrams of normal saline solution next to the extraction site.
Eligibility Criteria
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Inclusion Criteria
* Adults over the age of 18 years old.
* American Society of Anaesthesiologists (ASA) 1, and ASA 2
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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King Abdulaziz University
OTHER
Responsible Party
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Lojain Bassyoni
Oral and Maxillofacial Surgery Consultant and Assistant Professor
Locations
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King Abdulaziz University, Faculty of Dentistry
Jeddah, Mecca Region, Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Google drive link that contains all information regarding the study
Other Identifiers
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225-11-23
Identifier Type: -
Identifier Source: org_study_id
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