Endodontic Posts Using the CAD/CAM Digital Method.

NCT07297108 | Active Not Recruiting

• 1 other identifier: 203/30-11-2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the survival and success rates of endodontic posts exclusively fabricated using the CAD/CAM digital method over a period of 5 years of intraoral use. The objective is to evaluate the efficacy and long-term outcomes of the digital approach compared to traditional techniques, aiming to determine the reliability and precision of CAD/CAM technology in the fabrication of endodontic post restorations.

Conditions

Endodontic Treatment; Tooth Restoration

Keywords

CAD/CAM; intraoral Scanners; post fabrication; endodontic posts

Outcome Measures

Primary Outcomes (1)

• Survival Rate of CAD/CAM Endodontic Posts

  The primary outcome measure is the survival rate of endodontic posts fabricated using the CAD/CAM digital method. Survival is defined as the post remaining in situ without any signs of dislodgement, root fracture, or clinical failure necessitating replacement. Posts will be evaluated periodically to monitor their clinical performance and integrity, ensuring that no adverse events such as post loosening or tooth failure occur

  Assessed over a period of 5 years post-placement

Study Arms (2)

Experimental: Lithium Disilicate CAD/CAM Posts

EXPERIMENTAL

Patients in this arm receive custom CAD/CAM posts fabricated from lithium disilicate. All posts are designed, milled, and cemented using standardized preparation, adhesive, and cementation protocols. Clinical follow-up evaluates post survival, success rates, biological response, and the need for repair or replacement over time.

Device: Lithium Disilicate CAD/CAM Post

Active Comparator: Polymer-Based CAD/CAM Posts

ACTIVE COMPARATOR

Patients in this arm receive custom CAD/CAM posts fabricated from high-performance polymer materials. Posts are manufactured and cemented using the same standardized clinical workflow applied in Arm 1. This arm allows comparison of survival, success rates, functional stability, and biological outcomes relative to lithium disilicate CAD/CAM posts.

Device: Active Comparator: Polymer-Based CAD/CAM Posts

Interventions

Lithium Disilicate CAD/CAM Post DEVICE

Patients in this arm receive custom CAD/CAM posts fabricated from lithium disilicate. All posts are designed, milled, and cemented using standardized preparation, adhesive, and cementation protocols. Clinical follow-up evaluates post survival, success rates, biological response, and the need for repair or replacement over time.

Experimental: Lithium Disilicate CAD/CAM Posts

Active Comparator: Polymer-Based CAD/CAM Posts DEVICE

Patients in this arm receive custom CAD/CAM posts fabricated from high-performance polymer materials. Posts are manufactured and cemented using the same standardized clinical workflow applied in Arm 1. This arm allows comparison of survival, success rates, functional stability, and biological outcomes relative to lithium disilicate CAD/CAM posts.

Active Comparator: Polymer-Based CAD/CAM Posts

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 18 to 70 years
• Patients requiring endodontic treatment with post placement
• Individuals with adequate tooth structure to support a post restoration
• Patients who consent to participate and commit to follow-up visits for a period of 5 years
• Good overall oral health with no active periodontal disease

You may not qualify if:

• Patients with systemic conditions that could affect oral health or healing (e.g., uncontrolled diabetes or immune-compromising diseases)
• Individuals with severe periodontal disease or compromised tooth structure unsuitable for post placement
• Pregnant or breastfeeding women
• Patients unwilling or unable to commit to the 5-year follow-up period
• Individuals with allergies or adverse reactions to dental materials used in the CAD/CAM process
• Minimum Age = 18 Years and Maximum Age = 70 Years

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

School of Dentisty, Aristotle University of Thessaloniki

Thessaloniki, 54124, Greece

Location

Study Officials

• Kosmas Tolidis, Professor

  School of Dentistry, Aristotle University of Thessaloniki

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial; no parties are masked in this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study uses a parallel-group interventional model in which patients are allocated to different treatment arms corresponding to distinct types of indirect restorations or restorative materials. Each participant receives only the assigned intervention, performed under standardized preparation, adhesive, and cementation protocols. The model allows comparison of clinical performance, survival, and success rates among the different restorative approaches. All groups are followed longitudinally using predefined clinical and radiographic criteria to assess restoration integrity, functional stability, biological compatibility, and the need for repair or replacement.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: November 30, 2023
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2029
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)