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

1 juin 2026 mis à jour par: 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).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Procédure: 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.
Autres noms:
  • Impacted third molar surgery
  • Mandibular third molar odontectomy
Comparateur actif: 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.
Procédure: 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.
Autres noms:
  • Impacted third molar surgery
  • Mandibular third molar odontectomy
Médicament: 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.
Autres noms:
  • Prednol-L
Comparateur actif: 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.
Procédure: 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.
Autres noms:
  • Impacted third molar surgery
  • Mandibular third molar odontectomy
Médicament: 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.
Autres noms:
  • décoration

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Three-Dimensional Facial Edema
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Postoperative Pain Intensity via Visual Analog Scale
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Irfan Üstündağ

Les enquêteurs

  • Chercheur principal: irfan ustundag, dr.ogr.uyesi, inonu universitesi

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 mars 2026

Achèvement primaire (Réel)

1 avril 2026

Achèvement de l'étude (Réel)

9 avril 2026

Dates d'inscription aux études

Première soumission

1 juin 2026

Première soumission répondant aux critères de contrôle qualité

1 juin 2026

Première publication (Réel)

4 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2024-KAEK-08-3D

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage IPD

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

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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