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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Tomás Yoma Galleguillos, DDS
- Telefonnummer: +56985768407
- E-post: tomasyoma@gmail.com
Studieorter
-
-
Santiago Metropolitan
-
Santiago, Santiago Metropolitan, Chile
- Rekrytering
- Hospital San Jose
-
Kontakt:
- Tomás Yoma Galleguillos, DDS
- Telefonnummer: +56985768407
- E-post: tomasyoma@gmail.com
-
Huvudutredare:
- Tomás Yoma Galleguillos, DDS
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clinical performance of onlay and overlay restorations according to revised World Dental Federation (FDI) criteria.
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Restoration survival rate
Tidsram: 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
Tidsram: 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
Tidsram: 36 months
|
Proportion of restorations requiring replacement during the 36-month follow-up period.
|
36 months
|
|
Clinical complications
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Tomás Yoma Galleguillos, DDS, Hospital San José, Santiago, Chile
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HSJ-RCT-3DPRINT-001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .