Survival and Success of CAD/CAM Restorations After 5 Years of Intraoral Use

December 9, 2025 updated by: Aristotle University Of Thessaloniki

Comparative Study of Survival and Success of Restorations Exclusively Using the CAD/CAM Digital Method After 5 Years of Intraoral Use

This study evaluates the survival and success rates of dental restorations fabricated exclusively using CAD/CAM technology over a period of 5 years. The study will involve placing CAD/CAM restorations using a digital workflow that includes intraoral scanning, computer-aided design (CAD), and computer-aided manufacturing (CAM). The restorations will be monitored for factors such as marginal adaptation, wear resistance, and patient-reported outcomes. The goal is to determine the long-term clinical effectiveness of CAD/CAM restorations compared to traditional methods. The findings aim to improve the understanding and application of digital dental technology in clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54124
        • Aristotle University Of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 18-65 years
  • Patients with single or multiple CAD/CAM restorations placed within the last 5 years
  • Adequate oral hygiene and willingness to participate in follow-up assessments
  • Healthy periodontal status or controlled periodontal condition Signed informed consent form

Exclusion Criteria:

  • Patients with systemic diseases affecting oral health (e.g., diabetes, osteoporosis)
  • Pregnant or breastfeeding individuals
  • Smokers or individuals with a history of heavy smoking
  • Patients with untreated dental caries or advanced periodontal disease
  • Individuals with previous allergic reactions to CAD/CAM materials used

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CAD/CAM Restoration Arm
This arm involves the placement of dental restorations using CAD/CAM technology. Participants receive restorations fabricated through a digital workflow, which includes intraoral scanning, CAD software design, and milling of the restorations using CAM equipment. The restorations are made from high-quality ceramic or composite materials, chosen based on their suitability for long-term intraoral use. The process eliminates the need for conventional impression techniques, ensuring a precise fit. Participants are monitored over a 5-year period to evaluate the survival rate and success of the restorations, focusing on factors such as marginal integrity, wear resistance, and patient-reported outcomes.
Device: CAD/CAM Digital Restoration Placement
This intervention involves the placement of dental restorations exclusively using CAD/CAM technology, which includes digital scanning, design, and milling of the restorations. The restorations are fabricated from high-quality ceramic or composite materials that are commonly used in CAD/CAM systems. The process begins with an intraoral scan to capture the patient's dental anatomy, followed by the design of the restoration using CAD software, and milling with CAM equipment. The restorations are then adjusted, finished, and cemented intraorally. This intervention is distinct as it utilizes a fully digital workflow without the use of conventional impression techniques, aiming to assess the long-term clinical performance, survival rate, and success of these restorations over a period of 5 years. The study monitors factors such as restoration integrity, marginal adaptation, wear resistance, and patient-reported outcomes
Other Names:
  • Digital Dental Restoration
  • Intraoral Scanning Technique
Device: Study of the Survival and Success of Endodontic Posts Using the CAD/CAM Digital Method After 5 Years of Intraoral Use
This intervention involves the exclusive use of the CAD/CAM digital method for fabricating and placing endodontic posts. The study evaluates the long-term survival and success rate of these posts over a period of 5 years in an intraoral setting. This method is distinct as it eliminates the need for traditional impression techniques, utilizing digital scanning and milling for precise and consistent post fabrication. The focus is on comparing outcomes with those of conventional analog methods to establish the efficacy and reliability of the CAD/CAM approach.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Survival Rate of CAD/CAM Restorations Over 5 Years
Time Frame: 5 years post-restoration
This outcome measure evaluates the survival rate of CAD/CAM restorations over a 5-year period. Survival is defined as restorations remaining functional without failure such as fracture, debonding, or significant wear that would require replacement or major repair."
5 years post-restoration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aristotle University Of Thessaloniki

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: KOSMAS TOLIDIS, PROFESSOR, PROFESSOR, SCHOOL OF DENTISTRY, ARISTOTLE UNIVERISTY OF THESSALONIKI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 157/04-04-2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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