Clinical Evaluation of Two Post Systems for Single Crown Restoration of Anterior Teeth: A Randomized Controlled Clinical Trial
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Mohamed elsayed Bekhiet, Master Degree
- Telefonnummer: +201224238808
- E-Mail: Mohamed.Bekhet@dentistry.cu.edu.eg
Studienorte
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Manial
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Cairo, Manial, Ägypten, 11553
- Faculty of Dentistry Cairo University
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Kontakt:
- Mohamed elsayed Bekhiet, master degree
- Telefonnummer: +2.1224238808
- E-Mail: Mohamed.Bekhet@dentistry.cu.edu.eg
-
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: 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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Experimental: 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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Post-Gutta-Percha Gap Distance
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Post and Restoration Retention
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Mohamed labib zamzam, PHD, Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University
- Studienstuhl: omnia nabil, PHD, Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- CEBD-CU-2025-07-29
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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