Clinical Evaluation of Two Post Systems for Single Crown Restoration of Anterior Teeth: A Randomized Controlled Clinical Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Endodontically treated maxillary anterior teeth frequently present with significant loss of coronal tooth structure, compromising their resistance to fracture and complicating restoration. prefabricated fiber posts are widely used to retain a composite core prior to crown placement, but the degree to which a post adapts to the internal canal wall - leaving minimal or no gap between the post and the remaining gutta-percha - may influence long-term clinical performance and resistance to microleakage.
This study is a randomized controlled trial comparing a custom-adapted ultra-high-molecular-weight polyethylene (UHMWPE) fibers post (Ribbond-type), individually formed to the canal anatomy, against a prefabricated fiber post. Eligible teeth are endodontically treated maxillary anterior teeth with 1-2 missing coronal axial walls (mesial, distal, labial, and/or palatal), assessed at the cementoenamel junction, where any remaining sound walls meet a minimum height of 1.5-2 mm and a circumferential thickness of approximately 1 mm, in line with established ferrule criteria.
Participants will be randomly allocated to receive either the Ribbond post or the prefabricated fiber post, followed by a standardized composite core build-up and definitive crown restoration. Post space preparation, dentin conditioning, and cementation will follow a standardized step-by-step clinical protocol for each group.
The primary outcome is the post-gutta-percha gap distance, measured radiographically and expressed continuously in millimeters, with cases additionally classified as showing no gap versus any measurable gap. This dichotomization and its expected baseline distribution are informed by prior clinical data reporting outcomes in maxillary anterior teeth. The secondary outcome is post and restoration retention, evaluated clinically at follow-up using USPHS criteria.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mohamed elsayed Bekhiet, Master Degree
- Numéro de téléphone: +201224238808
- E-mail: Mohamed.Bekhet@dentistry.cu.edu.eg
Lieux d'étude
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Manial
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Cairo, Manial, Egypte, 11553
- Faculty of Dentistry Cairo University
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Contact:
- Mohamed elsayed Bekhiet, master degree
- Numéro de téléphone: +2.1224238808
- E-mail: Mohamed.Bekhet@dentistry.cu.edu.eg
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Endodontically treated maxillary anterior teeth (incisors and/or canines)
- Presence of 1-2 missing coronal axial walls (mesial, distal, labial, and/or palatal), assessed at the cementoenamel junction (CEJ)
- Remaining sound tooth structure meeting minimum ferrule criteria: wall height ≥1.5-2 mm and circumferential thickness ≈1 mm
- Adequate root canal filling with no radiographic signs of periapical pathology
- Root length and canal morphology suitable for post space preparation
- Patients aged 20-40 years
- Willing and able to provide informed consent and attend follow-up visits
Exclusion Criteria:
- Teeth with 3 or more missing coronal axial walls (insufficient ferrule)
- Evidence of active periapical pathology, root fracture, or root resorption
- Insufficient remaining root length for adequate post retention
- Signs of periodontal disease affecting tooth prognosis (e.g., mobility, inadequate periodontal support)
- Systemic conditions contraindicating routine dental treatment
- Pregnancy (if radiographic follow-up is required)
- Inability to attend scheduled follow-up visits
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Prefabricated Fiber Post with Composite Core
Participants receive a prefabricated fiber post, followed by a composite core build-up and definitive crown restoration.
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Participants receive a custom-fit UHMWPE fiber post, individually adapted to the canal at chairside, followed by a composite core build-up and definitive crown restoration.
|
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Expérimental: Custom-Fit UHMWPE Fiber Post with Composite Core
Participants receive a custom-fit UHMWPE fiber post, individually adapted to the canal at chairside, followed by a composite core build-up and definitive crown restoration.
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Participants receive a custom-fit UHMWPE fiber post, individually adapted to the canal at chairside, followed by a composite core build-up and definitive crown restoration.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Post-Gutta-Percha Gap Distance
Délai: Immediately post-cementation (baseline)
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Distance between the outer surface of the cemented post and the residual root canal filling (gutta-percha), measured radiographically at the coronal, middle, and apical thirds of the post space.
Reported both as a continuous measurement (mm) and dichotomized as no gap versus any measurable gap.
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Immediately post-cementation (baseline)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Post and Restoration Retention
Délai: 6 months post-cementation
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Clinical retention of the post-core-crown restoration, assessed using United States Public Health Service (USPHS) criteria.
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6 months post-cementation
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Mohamed labib zamzam, PHD, Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University
- Chaise d'étude: omnia nabil, PHD, Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University
Publications et liens utiles
Publications générales
- Moezizadeh M, Shokripour M. Effect of fiber orientation and type of restorative material on fracture strength of the tooth. J Conserv Dent. 2011 Oct;14(4):341-5. doi: 10.4103/0972-0707.87194.
- de Morais DC, Butler S, Santos MJMC. Current Insights on Fiber Posts: A Narrative Review of Laboratory and Clinical Studies. Dent J (Basel). 2023 Oct 10;11(10):236. doi: 10.3390/dj11100236.
- Naim H, Ahmad M, Ageeli AA, Abuarab RK, Sayed ME, Dewan H, Chohan H, Alshehri AH, Wadei MHDA, Alqahtani SM, Feroz SMA, Porwal A, Alshahrani AA. Radiographic Evaluation of the Gap between Cemented Post and Remaining Gutta-Percha in Endodontically Treated Teeth Performed by Undergraduate Students: A Retrospective Cross-Sectional Study. Medicina (Kaunas). 2023 Mar 3;59(3):502. doi: 10.3390/medicina59030502.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Autres numéros d'identification d'étude
- CEBD-CU-2025-07-29
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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