Milled vs 3D-Printed Partial-Coverage Restorations in Endodontically Treated Molars
Clinical Performance of CAD/CAM-Milled Versus 3D-Printed Composite Resin Partial-Coverage Restorations for Endodontically Treated Molars: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to compare the clinical performance of Computer-Aided Design and Computer-Aided Manufacturing (CAD/CAM)-milled and 3D-printed composite resin partial-coverage restorations in endodontically treated molars.
The main questions it aims to answer are:
- Do 3D-printed composite resin partial-coverage restorations show similar clinical performance compared with CAD/CAM-milled composite resin restorations?
- Are there differences in survival, success rates, and complications between the two types of restorations over a 3-year follow-up period?
Researchers will compare CAD/CAM-milled composite resin restorations with 3D-printed composite resin restorations to evaluate their clinical performance.
Participants will:
- Receive a partial-coverage restoration (onlay or overlay) in an endodontically treated molar.
- Be randomly assigned to receive either a CAD/CAM-milled or a 3D-printed composite resin restoration.
- Attend follow-up visits at 12, 24, and 36 months.
- Undergo clinical evaluations by two blinded evaluators using the revised FDI criteria and standardized photographic documentation.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
This randomized controlled clinical trial evaluates the clinical performance of indirect composite resin partial-coverage restorations fabricated using subtractive and additive manufacturing technologies in endodontically treated molars.
The study investigates whether 3D-printed composite resin restorations can achieve clinical outcomes comparable to CAD/CAM-milled composite resin restorations when used for cuspal coverage of structurally compromised posterior teeth.
All restorations will be fabricated using a fully digital workflow. Tooth preparation, immediate dentin sealing, digital intraoral scanning, restoration fabrication, and adhesive cementation procedures will be standardized and performed according to a predefined clinical protocol.
The trial will be conducted at Hospital San José, Santiago, Chile, using commercially available restorative materials manufactured by subtractive and additive technologies. Clinical performance will be evaluated according to internationally accepted restorative assessment criteria.
The study aims to generate medium-term clinical evidence regarding the use of 3D-printed composite resin restorations as a potential alternative to conventional CAD/CAM-milled restorations in restorative dentistry.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Tomás Yoma Galleguillos, DDS
- Telefonnummer: +56985768407
- E-post: tomasyoma@gmail.com
Studiesteder
-
-
Santiago Metropolitan
-
Santiago, Santiago Metropolitan, Chile
- Rekruttering
- Hospital San Jose
-
Ta kontakt med:
- Tomás Yoma Galleguillos, DDS
- Telefonnummer: +56985768407
- E-post: tomasyoma@gmail.com
-
Hovedetterforsker:
- Tomás Yoma Galleguillos, DDS
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Adults aged 18 to 70 years
- Absence of active periodontal disease
- Good oral hygiene (O'Leary plaque index <20%)
- Absence of parafunctional habits (e.g., bruxism, onychophagia)
- Endodontically treated first molars (maxillary or mandibular) with extensive Class II cavities and loss of at least one cusp, requiring onlay or overlay restoration
- Tooth with functional occlusal contact and at least one proximal contact
- Referred from the Endodontics Department of Hospital San José, with endodontic treatment completed at the same institution
- Ability to provide written informed consent
- Ability to attend follow-up visits at 12, 24, and 36 months
Exclusion Criteria:
- Untreated active periodontal disease
- Poor oral hygiene (O'Leary plaque index ≥20%)
- Generalized active caries
- Active parafunctional habits
- Teeth with complete circumferential structural destruction or insufficient coronal tooth structure for onlay/overlay restoration
- Subgingival margins compromising the biologic width
- Known allergy to study materials
- Pregnancy or breastfeeding
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Milled Composite Resin Onlay/Overlay
Participants receive indirect onlay or overlay restorations fabricated from milled composite resin blocks (HC Block, Shofu, Japan) for the rehabilitation of endodontically treated molars with extensive loss of tooth structure.
Tooth preparation, immediate dentin sealing, digital impression, and adhesive cementation procedures are standardized for all participants
|
Indirect partial coverage restoration fabricated from milled composite resin blocks (HC Block, Shofu, Japan) and adhesively cemented on endodontically treated molars.
|
|
Eksperimentell: 3D-Printed Composite Resin Onlay/Overlay
Participants receive indirect onlay or overlay restorations fabricated from 3D-printed composite resin (Rodin Sculpture, Pac-Dent, USA) for the rehabilitation of endodontically treated molars with extensive loss of tooth structure.
Tooth preparation, immediate dentin sealing, digital impression, and adhesive cementation procedures are standardized for all participants.
|
Indirect partial coverage restoration fabricated from 3D-printed composite resin (Rodin Sculpture, Pac-Dent, USA) and adhesively cemented on endodontically treated molars.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical performance of onlay and overlay restorations according to revised World Dental Federation (FDI) criteria.
Tidsramme: Baseline, 12 months, 24 months, and 36 months (primary endpoint at 36 months)
|
Clinical performance of milled and 3D-printed composite resin onlay and overlay restorations assessed using the revised FDI criteria.
An overall FDI evaluation score will be assigned to each restoration by two blinded evaluators.
|
Baseline, 12 months, 24 months, and 36 months (primary endpoint at 36 months)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Restoration survival rate
Tidsramme: 36 months
|
Survival of milled and 3D-printed composite resin onlay and overlay restorations.
A restoration will be considered surviving if it remains in function at follow-up, regardless of the need for minor repair.
|
36 months
|
|
Restoration success rate
Tidsramme: 36 months
|
Success of restorations according to revised FDI criteria.
Restorations receiving clinically acceptable ratings and not requiring corrective intervention will be considered successful.
|
36 months
|
|
Restoration failure rate
Tidsramme: 36 months
|
Proportion of restorations requiring replacement during the 36-month follow-up period.
|
36 months
|
|
Clinical complications
Tidsramme: Baseline to 36 months
|
Frequency and type of clinical complications observed during the 36-month follow-up period, including mechanical, biological, and esthetic complications associated with the restorations.
|
Baseline to 36 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Tomás Yoma Galleguillos, DDS, Hospital San José, Santiago, Chile
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HSJ-RCT-3DPRINT-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .