Evaluation of Corticosteroid Administration Following Impacted Third Molar Surgery Using 3-Dimensional Facial Analysis

Local Submucosal Dexamethasone Versus Methylprednisolone for Pain and Three-Dimensional Facial Edema After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial

The purpose of this prospective, randomized, controlled, single-blind clinical trial is to compare the efficacy of local submucosal administration of dexamethasone versus methylprednisolone on postoperative morbidity following impacted lower third molar surgery. The study evaluates postoperative pain using the Visual Analog Scale (VAS) and quantifies three-dimensional facial edema using a mobile smartphone-based scanning workflow (Qlone aligned in CloudCompare). Patients requiring unilateral extraction of fully bone-impacted mandibular third molars are randomly allocated into three parallel groups: Control (no injection), Methylprednisolone (40 mg), and Dexamethasone (8 mg).

Study Overview

• Status: Completed
• Conditions: Postoperative Pain Control; Postoperative Edema and Pain; Impacted Mandibular Third Molar Extraction
• Intervention / Treatment: Procedure: Surgical Extraction of Impacted Mandibular Third Molar; Drug: methylprednisolone sodium succinate; Drug: Dexamethasone Sodium Phosphate Injection

Detailed Description

Surgical extraction of impacted mandibular third molars routinely induces significant inflammatory sequelae, including pain, edema, and trismus, which substantially impair patient quality of life. Although local submucosal corticosteroid delivery is a well-established adjunctive approach to minimize postoperative discomfort, head-to-head volumetric comparisons using three-dimensional facial analysis workflows remain limited. This clinical trial implements a rigorous parallel design to isolate the anti-inflammatory efficacy of two widely utilized corticosteroids. Following a standardized surgical osteotomy and tooth removal performed by a single experienced surgeon, participants receive either a standardized 2 mL submucosal injection of 40 mg methylprednisolone sodium succinate, 8 mg dexamethasone sodium phosphate, or no injection at the distobuccal aspect of the adjacent second molar. Three-dimensional digital surface models are acquired preoperatively and longitudinally on postoperative days 3 and 7 to evaluate precise volumetric facial changes. Concurrently, subjective patient-reported pain kinetics are systematically dökümante edilmiştir via regular VAS recordings.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Malatya
    • Malatya, Malatya, Turkey (Türkiye), 44050
      • Inonu University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1. Systemically healthy individuals classified as ASA I according to the American Society of Anesthesiologists.

  2. Patients between 18 and 35 years of age. 3. Presence of a unilateral, fully bone-impacted mandibular third molar with an indication for surgical extraction.

  4. Impacted teeth classified as Class II or III and Position B or C according to the Pell-Gregory classification system.

  5. Impacted teeth with mesioangular or vertical angulation based on Winter's classification.

  6. A moderate surgical difficulty level (score of 5 to 7) confirmed via the Pederson difficulty index.

  7. Competency to provide written informed consent and willingness to adhere to follow-up schedules.

Exclusion Criteria:

• 1. Presence of any systemic disease or medical condition that contraindicates the use of systemic or local corticosteroids.

  2. Pregnancy or lactation. 3. Active pericoronitis, acute infection, or pathology (e.g., cysts, tumors) associated with the target third molar or adjacent structures.

  4. Use of antibiotics, systemic corticosteroids, or regular anti-inflammatory medications within the past 30 days prior to surgery.

  5. History of daily tobacco smoking within the past 6 months. 6. Known allergy or hypersensitivity to local anesthetics, dexamethasone, methylprednisolone, or the prescribed postoperative medications (amoxicillin, clavulanic acid, paracetamol, dexketoprofen).

  7. Inability to comply with the 3D facial scanning protocols or postoperative follow-up appointments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Control Group; Patients in this arm undergo the standardized surgical extraction of a fully bone-impacted mandibular third molar under local anesthesia. No local pharmacological adjuncts, sham injections, or submucosal applications of any corticosteroid or alternative therapeutic agents are administered following the completion of the tooth extraction and surgical debridement.	Procedure: Surgical Extraction of Impacted Mandibular Third Molar; All patients in the study undergo a standardized surgical removal of a fully bone-impacted lower third molar performed by a single experienced surgeon. Under general anesthesia, a triangular flap is elevated, followed by conservative osteotomy and tooth division using rotary instruments under continuous sterile saline irrigation. After tooth delivery, the socket is thoroughly debrided, irrigated, and closed primarily using 3-0 silk sutures.; Other Names: Impacted third molar surgery; Mandibular third molar odontectomy
Active Comparator: Group 2: Methylprednisolone Group; Following the standardized surgical extraction of the impacted mandibular third molar, patients in this arm receive a local submucosal injection of 40 mg methylprednisolone sodium succinate (Prednol-L). The drug is reconstituted with its specific solvent to a final volume of 2 mL and slowly delivered directly into the adjacent mandibular mucobuccal fold.	Procedure: Surgical Extraction of Impacted Mandibular Third Molar; All patients in the study undergo a standardized surgical removal of a fully bone-impacted lower third molar performed by a single experienced surgeon. Under general anesthesia, a triangular flap is elevated, followed by conservative osteotomy and tooth division using rotary instruments under continuous sterile saline irrigation. After tooth delivery, the socket is thoroughly debrided, irrigated, and closed primarily using 3-0 silk sutures.; Other Names: Impacted third molar surgery; Mandibular third molar odontectomy; Drug: methylprednisolone sodium succinate; Immediately following the completion of the tooth extraction and before structural flap closure, a single local dose of 40 mg methylprednisolone sodium succinate is administered. The lyophilized powder is reconstituted with its commercial solvent to a final volume of 2 mL and injected slowly into the adjacent submucosal mucobuccal fold.; Other Names: Prednol-L
Active Comparator: Group 3: Dexamethasone Group; Following the standardized surgical extraction of the impacted mandibular third molar, patients in this arm receive a local submucosal injection of 8 mg/2 mL dexamethasone sodium phosphate (Dekort). The commercial solution is administered slowly in its ready-to-use form directly into the adjacent mucobuccal fold.	Procedure: Surgical Extraction of Impacted Mandibular Third Molar; All patients in the study undergo a standardized surgical removal of a fully bone-impacted lower third molar performed by a single experienced surgeon. Under general anesthesia, a triangular flap is elevated, followed by conservative osteotomy and tooth division using rotary instruments under continuous sterile saline irrigation. After tooth delivery, the socket is thoroughly debrided, irrigated, and closed primarily using 3-0 silk sutures.; Other Names: Impacted third molar surgery; Mandibular third molar odontectomy; Drug: Dexamethasone Sodium Phosphate Injection; Immediately following the completion of the tooth extraction and before structural flap closure, a single local dose of 8 mg/2 mL dexamethasone sodium phosphate is administered. The ready-to-use commercial solution is injected slowly directly into the adjacent submucosal mucobuccal fold.; Other Names: dekort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Three-Dimensional Facial Edema	Volumetric soft tissue swelling on the operated side is quantified in cubic millimeters (mm³). Facial edema is calculated via digital superimposition and surface alignment of Qlone mobile 3D scans in CloudCompare software using the root mean square (RMS) method relative to the baseline scan.	Baseline (Preoperative) and Postoperative Day 3 and 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Intensity via Visual Analog Scale	Patient-reported subjective pain intensity scored on a standard 10-cm horizontal Visual Analog Scale (VAS), where 0 centimeters indicates "no pain" and 10 centimeters indicates "unbearable/worst imaginable pain".	Postoperative Days 1, 3, and 7
Rescue Analgesic Consumption	The total number of rescue analgesic tablets (25 mg dexketoprofen trometamol) consumed by each participant for breakthrough postoperative pain management during the follow-up period.	Up to 7 days postoperatively

Collaborators and Investigators

• Sponsor: Irfan Üstündağ
• Investigators: Principal Investigator: irfan ustundag, dr.ogr.uyesi, inonu universitesi

Publications and helpful links

General Publications

• Ngeow WC, Lim D. Do Corticosteroids Still Have a Role in the Management of Third Molar Surgery? Adv Ther. 2016 Jul;33(7):1105-39. doi: 10.1007/s12325-016-0357-y. Epub 2016 Jun 10.
• Lim D, Ngeow WC. A Comparative Study on the Efficacy of Submucosal Injection of Dexamethasone Versus Methylprednisolone in Reducing Postoperative Sequelae After Third Molar Surgery. J Oral Maxillofac Surg. 2017 Nov;75(11):2278-2286. doi: 10.1016/j.joms.2017.05.033. Epub 2017 Jun 8.
• Fernandez-Martin U, Lisbona-Gonzalez MJ, Vallecillo-Rivas M, Mallo-Magarinos M, Herrera-Briones FJ. Effect of Preoperative Administration of Dexamethasone vs. Methylprednisolone in Surgical Extraction of Impacted Lower Third Molars: Randomized Controlled Clinical Trial. J Clin Med. 2024 Aug 7;13(16):4614. doi: 10.3390/jcm13164614.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): April 9, 2026

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain; Mandibular Third Molar Surgery; Impacted Tooth Extraction; Submucosal Dexamethasone; Submucosal Methylprednisolone; Three-Dimensional Facial Analysis; Facial Edema Volumetric Measurement
• Additional Relevant MeSH Terms: Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Pain, Postoperative; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Methylprednisolone; Prednisolone; Methylprednisolone Hemisuccinate; dexamethasone 21-phosphate
• Other Study ID Numbers: 2024-KAEK-08-3D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results reported in the final manuscript (including demographic characteristics, baseline surgical parameters, 3D facial volumetric measurements, and pain VAS scores) will be made available to qualified researchers upon reasonable academic request.
• IPD Sharing Time Frame: The data will become available immediately following publication of the final manuscript and will remain accessible for up to 3 years.
• IPD Sharing Access Criteria: Data will be accessible to qualified clinical researchers upon submitting a scientifically sound research proposal. Requests should be directed via email to the corresponding author (dt.irfanustundag@gmail.com) and require a signed data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

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