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Completed

NCT Number: NCT07628166

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

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).

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Malatya, 44050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 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.

Exclusion criteria

  • 1. 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.

Treatment and study plan

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.

Other names: Impacted third molar surgery, Mandibular third molar odontectomy

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.

Other names: Prednol-L

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.

Other names: dekort

Primary outcomes

  1. Change in Three-Dimensional Facial Edema

    Time frame: Baseline (Preoperative) and Postoperative Day 3 and 7

    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.

Secondary outcomes

  1. Postoperative Pain Intensity via Visual Analog Scale

    Time frame: Postoperative Days 1, 3, and 7

    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".

  2. Rescue Analgesic Consumption

    Time frame: Up to 7 days postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Irfan Üstündağ

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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