Endodontic TreatmentNCT07297108
Endodontic Posts Using the CAD/CAM Digital Method.
A study testing Lithium Disilicate CAD/CAM Post and Active Comparator: Polymer-Based CAD/CAM Posts in people with Endodontic Treatment and Tooth Restoration, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Endodontic Treatment, Tooth Restoration
- What is being tested?
- Lithium Disilicate CAD/CAM Post and Active Comparator: Polymer-Based CAD/CAM Posts
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- 30 Nov 2023to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
School of Dentisty, Aristotle University of Thessaloniki
Thessaloniki, 54124
About this study
Official title: Study of the Survival and Success of Endodontic Posts Exclusively Using the CAD/CAM Digital Method After 5 Years of Intraoral Use
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.
Read the 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
- Conditions
- Endodontic Treatment, Tooth Restoration
- Being tested
- Lithium Disilicate CAD/CAM Post, Active Comparator: Polymer-Based CAD/CAM Posts
- Keywords
- CAD/CAM, intraoral Scanners, post fabrication, endodontic posts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium Disilicate CAD/CAM PostDevice
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 PostsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Active Comparator: Polymer-Based CAD/CAM Posts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessed over a period of 5 years post-placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start30 Nov 2023
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petros Mourouzis, Aristotle University Of Thessaloniki
- Investigators
- Kosmas Tolidis, Professor, Study chair, School of Dentistry, Aristotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297108
- Sponsor's protocol ID
- 203/30-11-2023
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) from this study will not be shared due to privacy and confidentiality concerns. The data collected includes sensitive patient information, and sharing it publicly may compromise participant anonymity and violate ethical guidelines. Furthermore, the study does not have the necessary infrastructure in place to ensure secure and compliant sharing of IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Survival and Success of Endodontic Posts Exclusively Using the CAD/CAM Digital Method After 5 Years of Intraoral Use
- ClinicalTrials.gov ID
- NCT07297108
- Acronym / sponsor ID
- 203/30-11-2023
- Conditions
- Endodontic Treatment, Tooth Restoration
- Keywords
- CAD/CAM, intraoral Scanners, post fabrication, endodontic posts
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Lithium Disilicate CAD/CAM Posts | Experimental | Device: Lithium Disilicate CAD/CAM PostPatients 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 | Active comparator | Device: Active Comparator: Polymer-Based CAD/CAM PostsPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lithium Disilicate CAD/CAM PostPatients 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 | Experimental: Lithium Disilicate CAD/CAM Posts |
| Active Comparator: Polymer-Based CAD/CAM PostsPatients 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 |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) from this study will not be shared due to privacy and confidentiality concerns. The data collected includes sensitive patient information, and sharing it publicly may compromise participant anonymity and violate ethical guidelines. Furthermore, the study does not have the necessary infrastructure in place to ensure secure and compliant sharing of IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kosmas Tolidis, Professor study chair
School of Dentistry, Aristotle University of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lithium Disilicate CAD/CAM Post and Active Comparator: Polymer-Based CAD/CAM Posts in people with Endodontic Treatment and Tooth Restoration, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Rate of CAD/CAM Endodontic Posts (time frame: Assessed over a period of 5 years post-placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.