MedDataX Logo

Endodontic Posts Using the CAD/CAM Digital Method.

NCT ID: NCT07297108

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2029-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This clinical study aims to evaluate 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 study focuses on the utilization of advanced digital technology for the design and fabrication of endodontic posts, which replaces traditional impression-taking and analog methods.

Participants in the study will undergo treatment where digital intraoral scanners will capture the post-space anatomy, and CAD software will be used to design custom posts that are then milled using CAM technology. The fabricated posts will be evaluated for fit, stability, and clinical performance over a prolonged period.

The primary outcome measures include the survival rate of the posts (absence of dislodgement or failure) and the success rate, which incorporates the functional and aesthetic integration of the post with the surrounding dental structures. Secondary outcomes will assess the incidence of complications such as root fractures, debonding, and endodontic failure.

This study distinguishes itself by exclusively using the digital CAD/CAM approach, with no involvement of traditional methods, ensuring precision and consistency in post fabrication. It aims to provide comprehensive data on the effectiveness and reliability of CAD/CAM technology for endodontic applications, offering insights that could influence clinical protocols and materials used in restorative dentistry

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endodontic Treatment Tooth Restoration

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

CAD/CAM intraoral Scanners post fabrication endodontic posts

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label trial; no parties are masked in this study.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental: Lithium Disilicate CAD/CAM Posts

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.

Group Type EXPERIMENTAL

Lithium Disilicate CAD/CAM Post

Intervention Type 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.

Active Comparator: Polymer-Based CAD/CAM Posts

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.

Group Type ACTIVE_COMPARATOR

Active Comparator: Polymer-Based CAD/CAM Posts

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lithium Disilicate CAD/CAM Post

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.

Intervention Type DEVICE

Active Comparator: Polymer-Based CAD/CAM Posts

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Petros Mourouzis

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kosmas Tolidis, Professor

Role: STUDY_CHAIR

School of Dentistry, Aristotle University of Thessaloniki

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

School of Dentisty, Aristotle University of Thessaloniki

Thessaloniki, , Greece

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Greece

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

203/30-11-2023

Identifier Type: -

Identifier Source: org_study_id