Tooth WearNCT07276269
Survival and Success of CAD/CAM Restorations After 5 Years of Intraoral Use
A study testing CAD/CAM Digital Restoration Placement and Study of the Survival and Success of Endodontic Posts Using the CAD/CAM Digital Method After 5 Years of Intraoral Use in people with Tooth Wear, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tooth Wear
- What is being tested?
- CAD/CAM Digital Restoration Placement and Study of the Survival and Success of Endodontic Posts Using the CAD/CAM Digital Method After 5 Years of Intraoral Use
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tooth Wear
- Being tested
- CAD/CAM Digital Restoration Placement, Study of the Survival and Success of Endodontic Posts Using the CAD/CAM Digital Method After 5 Years of Intraoral Use
- Keywords
- CAD/CAM, Lithium Disilicate, Digital Dentistry
- Medical subject headings
- Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM Digital Restoration PlacementDevice
Also called Digital Dental Restoration, Intraoral Scanning Technique
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
Study of the Survival and Success of Endodontic Posts Using the CAD/CAM Digital Method After 5 Years of Intraoral UseDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM Restoration Arm | Experimental | 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. Receives: Device: CAD/CAM Digital Restoration Placement; Device: Study of the Survival and Success of Endodontic Posts Using the CAD/CAM Digital Method After 5 Years of Intraoral Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate of CAD/CAM Restorations Over 5 Years
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."
Measured: 5 years post-restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 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 Tooth WearStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- 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
- Sponsor
- Investigators
- KOSMAS TOLIDIS, PROFESSOR, Study chair, PROFESSOR, SCHOOL OF DENTISTRY, ARISTOTLE UNIVERISTY OF THESSALONIKI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276269
- Sponsor's protocol ID
- 157/04-04-2022
- Status last verified
- Dec 2025
- First submitted
- 2 Apr 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Survival and Success of Restorations Exclusively Using the CAD/CAM Digital Method After 5 Years of Intraoral Use
- ClinicalTrials.gov ID
- NCT07276269
- Acronym / sponsor ID
- 157/04-04-2022
- Conditions
- Tooth Wear
- Keywords
- CAD/CAM, Lithium Disilicate, Digital Dentistry
- 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
- 11 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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM Restoration Arm | Experimental | Device: CAD/CAM Digital Restoration Placement, Device: Study of the Survival and Success of Endodontic Posts Using the CAD/CAM Digital Method After 5 Years of Intraoral UseThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| CAD/CAM Digital Restoration PlacementAlso: Digital Dental Restoration, Intraoral Scanning TechniqueThis 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 | Device | CAD/CAM Restoration Arm |
| Study of the Survival and Success of Endodontic Posts Using the CAD/CAM Digital Method After 5 Years of Intraoral UseThis 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. | Device | CAD/CAM Restoration Arm |
Primary outcome
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."
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 11 Dec 2025.
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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
PROFESSOR, SCHOOL OF DENTISTRY, ARISTOTLE UNIVERISTY 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 CAD/CAM Digital Restoration Placement and Study of the Survival and Success of Endodontic Posts Using the CAD/CAM Digital Method After 5 Years of Intraoral Use in people with Tooth Wear, 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 4 inclusion and 5 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 11 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 Restorations Over 5 Years (time frame: 5 years post-restoration). 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 11 Dec 2025.