Clinical Performance of Endodontically Treated Teeth Restored With Endocrowns and OverlaysNCT06734806
Clinical Evaluation of Endocrown and Overlay Restorations
An observational study of Clinical Performance of Endodontically Treated Teeth Restored With Endocrowns and Overlays, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Observational Study The goal of this observational study is to evaluate the clinical performance and patient satisfaction of endodontically treated teeth restored with endocrown and overlay restorations using feldspathic ceramic blocks over a 2 to 4-year period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Clinical Performance of Endodontically Treated Teeth Restored With Endocrowns and Overlays
- What is being tested?
- Radiographic Imaging and Digital STL Analysis and FDI Criteria Evaluation and Plaque Index Measurement
- Type of treatment
- Pill or oral medicine
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2019to 11 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of systemically healthy individuals aged 18 to 75 years who had at least one posterior tooth restored with a CEREC posterior restoration (endocrown and/or overlay) between January 2019 and September 2022. All restored teeth were in functional occlusion and located in a complete dental arch. Participants must have archived intraoral digital impressions (STL files) of the restored teeth. Patients were recruited from a private dental clinic specializing in restorative dentistry.
Who may be able to join
- Participants must have at least one posterior tooth restored with a CEREC posterior restoration (overlay and/or endocrown) during the specified period (January 2019 to September 2022).
- The restored tooth must be functional and in normal occlusal relationship.
- Participants must have archived intraoral digital impressions (STL files) of the restored teeth.
Who cannot join
- Individuals unwilling to cooperate.
- Teeth with endocrown or overlay restorations that were extracted.
- Participants younger than 18 or older than 75 years.
- Individuals with disabilities that could impede participation.
- Participants who have moved away or are deceased.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Dentistry, Erciyes University
Kayseri
About this study
Official title: Evaluation of the Clinical Performance of Endocrown and Overlay Restorations: A 4-Year Retrospective Study
Observational Study
The goal of this observational study is to evaluate the clinical performance and patient satisfaction of endodontically treated teeth restored with endocrown and overlay restorations using feldspathic ceramic blocks over a 2 to 4-year period. The main questions this study aims to answer are:
What are the survival rates of endocrown and overlay restorations in posterior teeth after 2 to 4 years? Are there differences in biological and mechanical failure rates between endocrown and overlay restorations? How do the cemented surface areas correlate with clinical outcomes? Participants who previously received endocrown or overlay restorations will undergo a clinical evaluation, including radiographic imaging, to assess secondary caries and restoration integrity. They will also rate their satisfaction with their restorations through a standardized survey. Retrospective STL file analysis will be used to measure cemented surface areas of the restorations.
Read the detailed description
This retrospective observational study aims to evaluate the clinical performance and patient satisfaction of endocrowns and overlay restorations fabricated from feldspathic ceramic CAD/CAM blocks over a period of 2 to 4 years. The study involves patients treated exclusively at the Private Ortoperio Dental Clinic in Kayseri, Turkey.
Endocrowns and overlays are widely used for restoring structurally compromised teeth. Endocrowns provide macro-retention by utilizing the pulp chamber and micro-retention through adhesive cementation, making them particularly suitable for endodontically treated teeth with limited crown height or narrow interocclusal spaces. Overlays, on the other hand, provide minimally invasive coverage while preserving the underlying tooth structure. Despite their popularity, long-term clinical data for these restorations remain limited.
The study will include 39 patients, aged between 18 and 75, who previously received endocrown or overlay restorations. Eligible participants must have functioning restorations placed at least 2 years prior, with records of digital impressions (STL files) archived at the clinic. Restorations will be evaluated using modified FDI criteria to assess aesthetic, functional, and biological outcomes. The criteria for failure include ceramic fractures, loosening, dislodgment, secondary caries, and periodontal issues. Patient satisfaction will also be measured using a Likert scale questionnaire.
Digital impressions of the cemented teeth will be analyzed using Materialise 3-matic software to calculate cemented surface areas. Additionally, the oral hygiene of participants will be assessed using the plaque index, and the mean plaque index score will be calculated for each patient. Statistical analyses will be conducted to determine potential factors affecting clinical outcomes, with methods to be determined based on data characteristics.
This study seeks to fill gaps in the literature by providing robust data on the survival rates and failure mechanisms of feldspathic ceramic endocrown and overlay restorations. Results are expected to guide clinicians in material selection and application techniques for achieving optimal outcomes in similar cases.
- Conditions
- Clinical Performance of Endodontically Treated Teeth Restored With Endocrowns and Overlays
- Being tested
- Radiographic Imaging and Digital STL Analysis, FDI Criteria Evaluation and Plaque Index Measurement
- Keywords
- Endocrown, Overlay restoration, Feldspathic ceramic, CAD/CAM dentistry, Retrospective study, Clinical performance, Adhesive dentistry, Plaque index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiographic Imaging and Digital STL AnalysisDiagnostic test
This study utilizes radiographic imaging (bitewing radiographs) and digital analysis of archived STL files to evaluate the clinical performance of endocrown and overlay restorations. The STL files are processed using Materialise 3-matic software to calculate cemented surface areas. Radiographic imaging assesses the presence of secondary caries or other failures. These diagnostic methods provide quantitative and visual data to evaluate long-term outcomes of the restorations.
FDI Criteria Evaluation and Plaque Index MeasurementDiagnostic test
This intervention includes the evaluation of dental restorations using modified FDI criteria, assessed on a 5-point Likert scale that measures aesthetic, functional, and biological outcomes. Additionally, oral hygiene is assessed through the measurement of the plaque index, with a mean score calculated for each participant. The use of both FDI-based Likert scoring and plaque index measurements allows for a detailed evaluation of restoration performance and oral health status, combining subjective patient-reported outcomes with objective clinical metrics.
| Study group | Role | What they receive |
|---|---|---|
| Endocrown | Not described Receives: Diagnostic Test: Radiographic Imaging and Digital STL Analysis; Diagnostic Test: FDI Criteria Evaluation and Plaque Index Measurement | |
| Overlay | Not described Receives: Diagnostic Test: Radiographic Imaging and Digital STL Analysis; Diagnostic Test: FDI Criteria Evaluation and Plaque Index Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Evaluation of Restorations Using FDI Criteria
The primary outcome measure involves scoring each restoration based on modified FDI criteria, including aesthetic, functional, and biological parameters. Two independent evaluators assessed each restoration, and a consensus score was recorded on a 5-point Likert scale.
Measured: 2 to 4 years after the placement of restorations, evaluated between October 3, 2024, and October 17, 2024.
Secondary outcomes (3)
Mean Plaque Index Score for Each Participant
Oral hygiene was assessed for each participant by calculating the mean plaque index score, providing an average value for oral hygiene status.
Measured: Assessed during clinical evaluations conducted between October 3, 2024, and October 17, 2024.
Secondary Caries Evaluation
Radiographic assessment was performed to detect the presence of secondary caries under or around each restoration, and the findings were documented as part of the clinical evaluation.
Measured: Evaluated during clinical examinations conducted between October 3, 2024, and October 17, 2024.
Cemented Surface Area Measurement
The cemented surface area of each restoration was calculated using STL files and analyzed with Materialise 3-matic software to correlate surface area with clinical outcomes.
Measured: Retrospective analysis conducted on archived STL files in November 2024.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start21 Jan 2019
- Primary completion17 Oct 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical Performance of Endodontically Treated Teeth Restored With Endocrowns and OverlaysStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haydar Albayrak, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734806
- Sponsor's protocol ID
- 2024/54 12/06/2024
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ayata M, Kucukomeroglu Oktay E, Albayrak H, Cakar M, Ozcan M. Evaluation of the clinical performance of endocrown and overlay restorations: A 4-year retrospective study. J Dent. 2025 Sep;160:105874. doi: 10.1016/j.jdent.2025.105874. Epub 2025 Jun 2.
PubMed 40466763
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Performance of Endocrown and Overlay Restorations: A 4-Year Retrospective Study
- ClinicalTrials.gov ID
- NCT06734806
- Acronym / sponsor ID
- 2024/54 12/06/2024
- Conditions
- Clinical Performance of Endodontically Treated Teeth Restored With Endocrowns and Overlays
- Keywords
- Endocrown, Overlay restoration, Feldspathic ceramic, CAD/CAM dentistry, Retrospective study, Clinical performance, Adhesive dentistry, Plaque index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 16 Dec 2024 (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.
Observational Study
The goal of this observational study is to evaluate the clinical performance and patient satisfaction of endodontically treated teeth restored with endocrown and overlay restorations using feldspathic ceramic blocks over a 2 to 4-year period. The main questions this study aims to answer are:
What are the survival rates of endocrown and overlay restorations in posterior teeth after 2 to 4 years? Are there differences in biological and mechanical failure rates between endocrown and overlay restorations? How do the cemented surface areas correlate with clinical outcomes? Participants who previously received endocrown or overlay restorations will undergo a clinical evaluation, including radiographic imaging, to assess secondary caries and restoration integrity. They will also rate their satisfaction with their restorations through a standardized survey. Retrospective STL file analysis will be used to measure cemented surface areas of the restorations.
Detailed description
This retrospective observational study aims to evaluate the clinical performance and patient satisfaction of endocrowns and overlay restorations fabricated from feldspathic ceramic CAD/CAM blocks over a period of 2 to 4 years. The study involves patients treated exclusively at the Private Ortoperio Dental Clinic in Kayseri, Turkey.
Endocrowns and overlays are widely used for restoring structurally compromised teeth. Endocrowns provide macro-retention by utilizing the pulp chamber and micro-retention through adhesive cementation, making them particularly suitable for endodontically treated teeth with limited crown height or narrow interocclusal spaces. Overlays, on the other hand, provide minimally invasive coverage while preserving the underlying tooth structure. Despite their popularity, long-term clinical data for these restorations remain limited.
The study will include 39 patients, aged between 18 and 75, who previously received endocrown or overlay restorations. Eligible participants must have functioning restorations placed at least 2 years prior, with records of digital impressions (STL files) archived at the clinic. Restorations will be evaluated using modified FDI criteria to assess aesthetic, functional, and biological outcomes. The criteria for failure include ceramic fractures, loosening, dislodgment, secondary caries, and periodontal issues. Patient satisfaction will also be measured using a Likert scale questionnaire.
Digital impressions of the cemented teeth will be analyzed using Materialise 3-matic software to calculate cemented surface areas. Additionally, the oral hygiene of participants will be assessed using the plaque index, and the mean plaque index score will be calculated for each patient. Statistical analyses will be conducted to determine potential factors affecting clinical outcomes, with methods to be determined based on data characteristics.
This study seeks to fill gaps in the literature by providing robust data on the survival rates and failure mechanisms of feldspathic ceramic endocrown and overlay restorations. Results are expected to guide clinicians in material selection and application techniques for achieving optimal outcomes in similar cases.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endocrown | – | Diagnostic Test: Radiographic Imaging and Digital STL Analysis, Diagnostic Test: FDI Criteria Evaluation and Plaque Index Measurement |
| Overlay | – | Diagnostic Test: Radiographic Imaging and Digital STL Analysis, Diagnostic Test: FDI Criteria Evaluation and Plaque Index Measurement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of systemically healthy individuals aged 18 to 75 years who had at least one posterior tooth restored with a CEREC posterior restoration (endocrown and/or overlay) between January 2019 and September 2022. All restored teeth were in functional occlusion and located in a complete dental arch. Participants must have archived intraoral digital impressions (STL files) of the restored teeth. Patients were recruited from a private dental clinic specializing in restorative dentistry.
Key inclusion criteria (3 listed)
- Participants must have at least one posterior tooth restored with a CEREC posterior restoration (overlay and/or endocrown) during the specified period (January 2019 to September 2022).
- The restored tooth must be functional and in normal occlusal relationship.
- Participants must have archived intraoral digital impressions (STL files) of the restored teeth.
Key exclusion criteria (5 listed)
- Individuals unwilling to cooperate.
- Teeth with endocrown or overlay restorations that were extracted.
- Participants younger than 18 or older than 75 years.
- Individuals with disabilities that could impede participation.
- Participants who have moved away or are deceased.
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 |
|---|---|---|
| Radiographic Imaging and Digital STL AnalysisThis study utilizes radiographic imaging (bitewing radiographs) and digital analysis of archived STL files to evaluate the clinical performance of endocrown and overlay restorations. The STL files are processed using Materialise 3-matic software to calculate cemented surface areas. Radiographic imaging assesses the presence of secondary caries or other failures. These diagnostic methods provide quantitative and visual data to evaluate long-term outcomes of the restorations. | Diagnostic test | Endocrown, Overlay |
| FDI Criteria Evaluation and Plaque Index MeasurementThis intervention includes the evaluation of dental restorations using modified FDI criteria, assessed on a 5-point Likert scale that measures aesthetic, functional, and biological outcomes. Additionally, oral hygiene is assessed through the measurement of the plaque index, with a mean score calculated for each participant. The use of both FDI-based Likert scoring and plaque index measurements allows for a detailed evaluation of restoration performance and oral health status, combining subjective patient-reported outcomes with objective clinical metrics. | Diagnostic test | Endocrown, Overlay |
Primary outcome
Clinical Evaluation of Restorations Using FDI Criteria
Time frame: 2 to 4 years after the placement of restorations, evaluated between October 3, 2024, and October 17, 2024.
The primary outcome measure involves scoring each restoration based on modified FDI criteria, including aesthetic, functional, and biological parameters. Two independent evaluators assessed each restoration, and a consensus score was recorded on a 5-point Likert scale.
3 secondary outcomes
Mean Plaque Index Score for Each Participant
Time frame: Assessed during clinical evaluations conducted between October 3, 2024, and October 17, 2024.
Secondary Caries Evaluation
Time frame: Evaluated during clinical examinations conducted between October 3, 2024, and October 17, 2024.
Cemented Surface Area Measurement
Time frame: Retrospective analysis conducted on archived STL files in November 2024.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 40466763Ayata M, Kucukomeroglu Oktay E, Albayrak H, Cakar M, Ozcan M. Evaluation of the clinical performance of endocrown and overlay restorations: A 4-year retrospective study. J Dent. 2025 Sep;160:105874. doi: 10.1016/j.jdent.2025.105874. Epub 2025 Jun 2.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Performance of Endodontically Treated Teeth Restored With Endocrowns and Overlays, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 16 Dec 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Evaluation of Restorations Using FDI Criteria (time frame: 2 to 4 years after the placement of restorations, evaluated between October 3, 2024, and October 17, 2024.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06734806, which also lists 1 linked publication.
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 16 Dec 2024.