Malformed ToothNCT06969911
Clinical Evaluation of CAD/CAM vs. Conventional Veneer Restorations
A study testing Laminate veneer CAD/CAM and Laminate Veneer Convetional in people with Malformed Tooth, run by Heinrich-Heine University, Duesseldorf.
Trial summary
The aim of the study is to clinically evaluate tooth-supported veneer restorations fabricated using the CAD/CAM process in comparison to conventionally manufactured pressed veneers on anterior teeth and to assess their long-term performance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malformed Tooth
- What is being tested?
- Laminate veneer CAD/CAM and Laminate Veneer Convetional
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2025to 31 Mar 2032
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age
- Patients that reveal indication for a minimum of 2 and a maximum of 6 anterior veneer restorations
Who cannot join
- Patients that reveal multiple missing teeth, poor oral hygiene, pronounced parafunctions or with allergies to any of the applied materials
About this study
Official title: Long-term Performance and Longevity of Minimally Invasive CAD/CAM Versus Conventional Anterior Veneer Restorations: a Randomized Controlled Trial Over 5 Years.
The aim of the study is to clinically evaluate tooth-supported veneer restorations fabricated using the CAD/CAM process in comparison to conventionally manufactured pressed veneers on anterior teeth and to assess their long-term performance. Survival and success rates of anterior veneer restorations, as well as patient satisfaction, will be evaluated.
Read the detailed description
Functional and aesthetic complaints caused by congenital malformations and acquired tooth damage are widely spread. Discomfort involves reduced chewing ability, phonetic problems, hypersensitivity and aesthetic impairments.
Conventionally fabricated all-ceramic veneer restorations reveal a long history of clinical success in minimally invasive rehabilitation of the anterior dentition. Nevertheless, conventional manufacturing techniques are prone to fabrication mistakes and must be handled by experienced dental technicians and dentists which results in very high fabrication costs. Therefore, access to minimally invasive restorations is currently restricted for most of the patients. Innovative CAD/CAM techniques have revolutionised restorative treatment options over the last decades and have made all-ceramic restorations more affordable for patients. With further improvements of the CAD/CAM milling devices the machinability of high-strength glass ceramic is now possible.
The aim of both treatment procedures will be to avoid any extensive additional tooth structure removal, to provide long-term survival and success of the integrated restorations and to improve patient´s satisfaction. Up to now scientific evidence on the clinical performance of CAD/CAM fabricated veneers is very limited. Aim of this trial is to evaluate if the clinical performance of anterior restorations after minimally invasive therapeutic intervention with CAD/CAM veneers compared to conventionally fabricated veneers. Functional and aesthetic treatment results will be assessed for five years and evaluated with regard to failure and succes veneer restorations as well as patient satisfaction.
- Conditions
- Malformed Tooth
- Being tested
- Laminate veneer CAD/CAM, Laminate Veneer Convetional
- Medical subject headings
- Tooth Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laminate veneer CAD/CAMProcedure or surgery
Minimally invasive therapeutic intervention with CAD/CAM veneers
Laminate Veneer ConvetionalProcedure or surgery
Minimally invasive therapeutic intervention with CAD/CAM veneers
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Conventional veneer restoration | Sham comparator | Therapeutic intervention with minimally invasive traditionally fabricated all-ceramic anterior veneers. Receives: Procedure: Laminate Veneer Convetional |
| Study Group: CAD/CAM veneer restoration | Active comparator | Therapeutic intervention with minimally invasive CAD/CAM all-ceramic anterior veneers. Receives: Procedure: Laminate veneer CAD/CAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic survival time
The primary objective is to compare the prosthetic survival time of the restorations (conventional vs. CAD/CAM veneers).
Measured: 5 Years
Secondary outcomes (1)
Prosthetic success
The secondary objectives are to compare the prosthetic success of the restorations (conventional vs. CAD/CAM veneers), the documentation of failures such as fractures and the assessment of patient centered satisfaction.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start5 May 2025 (estimated)
- Primary completion31 Mar 2032 (estimated)
- Study completion31 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malformed ToothStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969911
- Sponsor's protocol ID
- Heinrich-Heine University
- Status last verified
- Jan 2025
- First submitted
- 6 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Performance and Longevity of Minimally Invasive CAD/CAM Versus Conventional Anterior Veneer Restorations: a Randomized Controlled Trial Over 5 Years.
- ClinicalTrials.gov ID
- NCT06969911
- Acronym / sponsor ID
- Heinrich-Heine University
- Conditions
- Malformed Tooth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 5 May 2025 (estimated)
- Primary completion
- 31 Mar 2032 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 14 May 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.
The aim of the study is to clinically evaluate tooth-supported veneer restorations fabricated using the CAD/CAM process in comparison to conventionally manufactured pressed veneers on anterior teeth and to assess their long-term performance. Survival and success rates of anterior veneer restorations, as well as patient satisfaction, will be evaluated.
Detailed description
Functional and aesthetic complaints caused by congenital malformations and acquired tooth damage are widely spread. Discomfort involves reduced chewing ability, phonetic problems, hypersensitivity and aesthetic impairments.
Conventionally fabricated all-ceramic veneer restorations reveal a long history of clinical success in minimally invasive rehabilitation of the anterior dentition. Nevertheless, conventional manufacturing techniques are prone to fabrication mistakes and must be handled by experienced dental technicians and dentists which results in very high fabrication costs. Therefore, access to minimally invasive restorations is currently restricted for most of the patients. Innovative CAD/CAM techniques have revolutionised restorative treatment options over the last decades and have made all-ceramic restorations more affordable for patients. With further improvements of the CAD/CAM milling devices the machinability of high-strength glass ceramic is now possible.
The aim of both treatment procedures will be to avoid any extensive additional tooth structure removal, to provide long-term survival and success of the integrated restorations and to improve patient´s satisfaction. Up to now scientific evidence on the clinical performance of CAD/CAM fabricated veneers is very limited. Aim of this trial is to evaluate if the clinical performance of anterior restorations after minimally invasive therapeutic intervention with CAD/CAM veneers compared to conventionally fabricated veneers. Functional and aesthetic treatment results will be assessed for five years and evaluated with regard to failure and succes veneer restorations as well as patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: Conventional veneer restoration | Sham comparator | Procedure: Laminate Veneer ConvetionalTherapeutic intervention with minimally invasive traditionally fabricated all-ceramic anterior veneers. |
| Study Group: CAD/CAM veneer restoration | Active comparator | Procedure: Laminate veneer CAD/CAMTherapeutic intervention with minimally invasive CAD/CAM all-ceramic anterior veneers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥ 18 years of age
- Patients that reveal indication for a minimum of 2 and a maximum of 6 anterior veneer restorations
Key exclusion criteria (1 listed)
- Patients that reveal multiple missing teeth, poor oral hygiene, pronounced parafunctions or with allergies to any of the applied materials
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 |
|---|---|---|
| Laminate veneer CAD/CAMMinimally invasive therapeutic intervention with CAD/CAM veneers | Procedure or surgery | Study Group: CAD/CAM veneer restoration |
| Laminate Veneer ConvetionalMinimally invasive therapeutic intervention with CAD/CAM veneers | Procedure or surgery | Control Group: Conventional veneer restoration |
Primary outcome
Prosthetic survival time
Time frame: 5 Years
The primary objective is to compare the prosthetic survival time of the restorations (conventional vs. CAD/CAM veneers).
1 secondary outcome
Prosthetic success
Time frame: 5 Years
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 14 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laminate veneer CAD/CAM and Laminate Veneer Convetional in people with Malformed Tooth, run by Heinrich-Heine University, Duesseldorf.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Prosthetic survival time (time frame: 5 Years). 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 14 May 2025.