- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07604584
Effects of Platelet-Rich Fibrin After Mandibular Third Molar Surgery in Smokers and Nonsmokers
Effects of Platelet-Rich Fibrin on Postoperative Pain, Trismus and Swelling After Impacted Mandibular Third Molar Surgery in Smokers and Nonsmokers: A Prospective Clinical Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This prospective randomized split-mouth clinical trial was conducted between 2017 and 2019 at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ankara University. The study aimed to evaluate the effects of platelet-rich fibrin (PRF) on postoperative pain, swelling, trismus, and analgesic consumption after impacted mandibular third molar surgery in smoking and nonsmoking patients.
A total of 30 systemically healthy patients aged 18-35 years with bilaterally impacted mandibular third molars were included. Patients were divided into smoking and nonsmoking groups. In each patient, PRF was randomly applied to one extraction socket, while the contralateral socket served as the control site without PRF application. All surgical procedures were performed by the same oral and maxillofacial surgeon using a standardized surgical protocol. Outcome assessments were performed by a different clinician blinded to the intervention side.
Postoperative pain was evaluated using a visual analog scale (VAS). Facial swelling was assessed using linear facial measurements between anatomical landmarks, and trismus was evaluated by measuring maximum interincisal distance. Clinical evaluations were performed preoperatively and on postoperative days 1, 2, 3, and 7.
The primary outcome of the study was postoperative pain intensity. Secondary outcomes included postoperative swelling, trismus, and analgesic consumption. The study also aimed to compare the clinical effectiveness of PRF between smokers and nonsmokers.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Ankara, Turquie (Türkiye), 06560
- Ankara University Faculty of Dentistry
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Systemically healthy patients aged between 18 and 35 years
- Bilaterally impacted mandibular third molars
- Mandibular third molars classified as Pell and Gregory Class I, Position C
- Mandibular third molars classified as Parant Class II difficulty
- Smoking and nonsmoking patients
- Patients willing to participate and provide written informed consent
Exclusion Criteria:
- Presence of acute infection or pericoronitis
- Pregnancy or lactation
- Alcohol or substance abuse
- Use of oral contraceptives
- Menstrual period during surgery
- Antibiotic use within the previous month
- Smoking more than 10 cigarettes per day
- Agitation or inability to cooperate
- Incomplete follow-up data
- Systemic disease contraindicating oral surgery
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: PRF-treated socket
Platelet-rich fibrin (PRF) was placed into the extraction socket following impacted mandibular third molar surgery.
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Autologous platelet-rich fibrin prepared from venous blood by centrifugation and placed into the extraction socket after mandibular third molar extraction.
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Aucune intervention: Control socket
The contralateral extraction socket was primarily closed without PRF application after mandibular third molar surgery.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative Pain Intensity
Délai: Postoperative days 1, 2, 3, and 7
|
Postoperative pain intensity assessed using a 100-mm visual analog scale (VAS) after impacted mandibular third molar surgery.
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Postoperative days 1, 2, 3, and 7
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative Facial Swelling
Délai: Preoperative period and postoperative days 1, 2, 3, and 7
|
Postoperative facial swelling assessed using linear facial measurements between anatomical landmarks.
|
Preoperative period and postoperative days 1, 2, 3, and 7
|
|
Postoperative Trismus
Délai: Preoperative period and postoperative days 1, 2, 3, and 7
|
Trismus assessed by measuring maximum interincisal mouth opening distance.
|
Preoperative period and postoperative days 1, 2, 3, and 7
|
|
Postoperative Analgesic Consumption
Délai: Postoperative days 1, 2, 3, and 7
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Number of analgesic tablets used during the postoperative follow-up period.
|
Postoperative days 1, 2, 3, and 7
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mehmet Emre Yurttutan, PhD, DDS, Ankara University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 36290600/51
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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