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

NCT07628166 | Completed

• 1 other identifier: 2024-KAEK-08-3D
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Postoperative Edema and Pain; Postoperative Pain Control; Impacted Mandibular Third Molar Extraction

Keywords

Mandibular Third Molar Surgery; Impacted Tooth Extraction; Submucosal Dexamethasone; Submucosal Methylprednisolone; Postoperative Pain; Three-Dimensional Facial Analysis; Facial Edema Volumetric Measurement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative Pain Intensity via Visual Analog Scale

  Postoperative Days 1, 3, and 7

• Rescue Analgesic Consumption

  Up to 7 days postoperatively

Study Arms (3)

Group 1: Control Group

EXPERIMENTAL

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

Group 2: Methylprednisolone Group

ACTIVE COMPARATOR

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; Drug: methylprednisolone sodium succinate

Group 3: Dexamethasone Group

ACTIVE COMPARATOR

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; Drug: Dexamethasone Sodium Phosphate Injection

Interventions

Surgical Extraction of Impacted Mandibular Third Molar PROCEDURE

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.

Also known as: Impacted third molar surgery, Mandibular third molar odontectomy

Group 1: Control Group; Group 2: Methylprednisolone Group; Group 3: Dexamethasone Group

methylprednisolone sodium succinate DRUG

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.

Also known as: Prednol-L

Group 2: Methylprednisolone Group

Dexamethasone Sodium Phosphate Injection DRUG

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.

Also known as: dekort

Group 3: Dexamethasone Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Systemically healthy individuals classified as ASA I according to the American Society of Anesthesiologists.
• \. 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.
• \. Impacted teeth classified as Class II or III and Position B or C according to the Pell-Gregory classification system.
• \. Impacted teeth with mesioangular or vertical angulation based on Winter's classification.
• \. A moderate surgical difficulty level (score of 5 to 7) confirmed via the Pederson difficulty index.
• \. Competency to provide written informed consent and willingness to adhere to follow-up schedules.

You may not qualify if:

• \. Presence of any systemic disease or medical condition that contraindicates the use of systemic or local corticosteroids.
• \. Pregnancy or lactation. 3. Active pericoronitis, acute infection, or pathology (e.g., cysts, tumors) associated with the target third molar or adjacent structures.
• \. Use of antibiotics, systemic corticosteroids, or regular anti-inflammatory medications within the past 30 days prior to surgery.
• \. 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).
• \. Inability to comply with the 3D facial scanning protocols or postoperative follow-up appointments.

Sponsors & Collaborators

• Irfan Üstündağ: lead

Study Sites (1)

Inonu University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Malatya, Malatya, 44050, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 28666096 RESULT

• 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.

  PMID: 39200756 RESULT

• 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.

  PMID: 27287853 RESULT

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Methylprednisolone Hemisuccinate; dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• irfan ustundag, dr.ogr.uyesi

  inonu universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the absence of a placebo injection in the control group, complete patient and surgeon blinding could not be achieved. However, a single-blind design was rigorously maintained by completely blinding the clinical outcomes assessor, who performed the digital three-dimensional facial scanning superimpositions and volumetric edema data calculations in CloudCompare software, to the group allocations.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DR.ÖĞR.ÜYESİ

Model Details: This is a prospective, randomized, controlled, parallel-group clinical trial designed to compare the efficacy of local submucosal injections of dexamethasone versus methylprednisolone on postoperative pain and three-dimensional facial edema following the surgical extraction of fully bone-impacted mandibular third molars. Patients are assigned to one of three parallel arms at a 1:1:1 ratio.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 4, 2026
• Study Start: March 2, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 9, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available immediately following publication of the final manuscript and will remain accessible for up to 3 years.
• 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.

Locations

TU (1)