- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07297108
Endodontic Posts Using the CAD/CAM Digital Method.
Study of the Survival and Success of Endodontic Posts Exclusively Using the CAD/CAM Digital Method After 5 Years of Intraoral Use
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Thessaloniki, Greece, 54124
- School of Dentisty, Aristotle University of Thessaloniki
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival Rate of CAD/CAM Endodontic Posts
Time Frame: Assessed over a period of 5 years post-placement
|
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
|
Collaborators and Investigators
Investigators
- Study Chair: Kosmas Tolidis, Professor, School of Dentistry, Aristotle University of Thessaloniki
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 203/30-11-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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