Clinical trial NCT06953440: The Effect of Dexamethasone Submucosal Injection After Surgical Extraction of Lower Impacted Third Molars on Trismus and Edema
Official title: The Effect of Dexamethasone Submucosal Injection After Third Molar Surgery on Trismus and Edema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Swelling/ Edema
Trismus
Keywords: Extraction
third molar
wisdom teeth
dexamethasone
steroids
submucosal
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Patients will be randomly allocated to the test group or the control group by an allocation sequence that is done by the statistician.

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\&#39;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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Trismus and Swelling
timeFrame: From the day of extraction, the 2nd day of surgery, 4th day, and 7th day of surgery.
Secondary outcomes:
measure: Social Interaction
timeFrame: Patients will be followed up in the 2nd, 4th, and 7th postoperative days.
measure: Work Ability
timeFrame: Patients will be followed up in the 2nd, 4th, and 7th postoperative days.
measure: Eating Ability
timeFrame: Patients will be followed up in the 2nd, 4th, and 7th postoperative days.
measure: Sleep Impairment
timeFrame: Patients will be followed up in the 2nd, 4th, and 7th postoperative days.
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University, Faculty of Dentistry
state: Makkah
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.