Clinical trial NCT06734806: Clinical Evaluation of Endocrown and Overlay Restorations
Official title: Evaluation of the Clinical Performance of Endocrown and Overlay Restorations: A 4-Year Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Clinical Evaluation of Restorations Using FDI Criteria
timeFrame: 2 to 4 years after the placement of restorations, evaluated between October 3, 2024, and October 17, 2024.
Secondary outcomes:
measure: Mean Plaque Index Score for Each Participant
timeFrame: Assessed during clinical evaluations conducted between October 3, 2024, and October 17, 2024.
measure: Secondary Caries Evaluation
timeFrame: Evaluated during clinical examinations conducted between October 3, 2024, and October 17, 2024.
measure: Cemented Surface Area Measurement
timeFrame: Retrospective analysis conducted on archived STL files in November 2024.
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Faculty of Dentistry, Erciyes University
Study officials:
References: