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Clinical Evaluation of Two Post Systems for Single Crown Restoration of Anterior Teeth: A Randomized Controlled Clinical Trial

14. september 2026 opdateret af: Mohamed el sayed bekhiet, Cairo University
This randomized controlled trial evaluates two post systems used to restore endodontically treated (root canal treated) maxillary anterior teeth with 1-2 missing coronal walls. Participants will be randomly assigned to receive either a custom-adapted polyethylene fibers post (Ribbond-type, individually formed) or a prefabricated fiber post, followed by a composite core and crown restoration. The primary outcome is the distance between the post and the remaining root canal filling (gutta-percha), measured radiographically, which reflects how well the post adapts within the canal. The secondary outcome is post and restoration retention, assessed clinically using USPHS criteria. Participants will be followed for 6 months. The study aims to determine whether a custom-fitted fiber post provides better adaptation and retention compared to a standard prefabricated fiber post in teeth with significant structural loss.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

84

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Prefabricated Fiber Post with Composite Core
Participants receive a prefabricated fiber post, followed by a composite core build-up and definitive crown restoration.
Andet: 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.
Eksperimentel: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Post-Gutta-Percha Gap Distance
Tidsramme: Immediately post-cementation (baseline)
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.
Immediately post-cementation (baseline)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Post and Restoration Retention
Tidsramme: 6 months post-cementation
Clinical retention of the post-core-crown restoration, assessed using United States Public Health Service (USPHS) criteria.
6 months post-cementation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Efterforskere

  • Studieleder: Mohamed labib zamzam, PHD, Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University
  • Studiestol: omnia nabil, PHD, Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

2. oktober 2026

Primær færdiggørelse (Anslået)

1. februar 2027

Studieafslutning (Anslået)

1. marts 2027

Datoer for studieregistrering

Først indsendt

14. september 2026

Først indsendt, der opfyldte QC-kriterier

14. september 2026

Først opslået (Faktiske)

18. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CEBD-CU-2025-07-29

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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