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

1 giugno 2026 aggiornato da: Irfan Üstündağ

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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: 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.
Altri nomi:
  • Impacted third molar surgery
  • Mandibular third molar odontectomy
Comparatore attivo: 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.
Procedura: 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.
Altri nomi:
  • Impacted third molar surgery
  • Mandibular third molar odontectomy
Droga: 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.
Altri nomi:
  • Prednol-L
Comparatore attivo: 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.
Procedura: 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.
Altri nomi:
  • Impacted third molar surgery
  • Mandibular third molar odontectomy
Droga: 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.
Altri nomi:
  • decort

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Three-Dimensional Facial Edema
Lasso di tempo: 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.
Baseline (Preoperative) and Postoperative Day 3 and 7

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postoperative Pain Intensity via Visual Analog Scale
Lasso di tempo: 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".
Postoperative Days 1, 3, and 7
Rescue Analgesic Consumption
Lasso di tempo: 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.
Up to 7 days postoperatively

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Irfan Üstündağ

Investigatori

  • Investigatore principale: irfan ustundag, dr.ogr.uyesi, inonu universitesi

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 marzo 2026

Completamento primario (Effettivo)

1 aprile 2026

Completamento dello studio (Effettivo)

9 aprile 2026

Date di iscrizione allo studio

Primo inviato

1 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2024-KAEK-08-3D

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

The data will become available immediately following publication of the final manuscript and will remain accessible for up to 3 years.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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