Endodontically Treated Teeth
Conditions
Keywords
Ceramic, Crown, Endocrown
Brief summary
This investigation will be a longitudinal clinical trial to study the association of preparation design on the internal and marginal adaptation of the resulting restorations and the long-term clinical performance of chairside CAD/CAM endocrown restorations. Advanced lithium disilicate chairside CAD/CAM endocrowns (CEREC Tessera/Dentsply Sirona) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (Prime and Bond Elect/Dentsply Sirona) and a dual cure resin adhesive cement (Calibra Ceram/Dentsply Sirona). All restorations will be followed over five years of clinical service.
Detailed description
Endodontically treated teeth commonly present with extensive tooth structure loss due to caries, trauma, prior restorative treatment, and the endodontic access. These structural deficiencies lead to an increase in cusp deflection, crown fractures, microleakage, and decreased sensory feedback during function which greatly increases the possibility of tooth fracture.As a result, endodontically treated teeth require a full cuspal coverage restoration to prevent microleakage, restore function, and provide cuspal protection against tooth fracture. The most common restoration for endodontically treated teeth is core build-up, with or without a post, and full coverage crown. This process requires multiple appointments with many technical steps ultimately leading to more chair time, treatment cost, and potential iatrogenic damage to the tooth. An alternative treatment is the endocrown, which utilizes the internal walls of the pulp chamber for macroretention and incorporates the core and crown in a monolithic restoration. The restoration is fabricated utilizing chairside CAD/CAM technology and is adhesively bonded to the tooth with resin cement. The EndoCrown restoration is more conservative relative to tooth structure loss, less expensive, and requires less chair time to complete when compared to conventional treatment while having comparable clinical longevity in molar teeth. This investigation will be a longitudinal clinical trial to study the association of preparation design on the internal and marginal adaptation of the resulting restorations and the long-term clinical performance of chairside CAD/CAM endocrown restorations. Advanced lithium disilicate chairside CAD/CAM endocrowns (CEREC Tessera/Dentsply Sirona) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (Prime and Bond Elect/Dentsply Sirona) and a dual cure resin adhesive cement (Calibra Ceram/Dentsply Sirona). All restorations will be followed over five years of clinical service.
Interventions
DEVICECEREC Tessera
Full ceramic endocrown restorations will be made from the high strength ceramic, CEREC Tessera
Sponsors
University of Michigan
Dentsply Sirona Implants and Consumables
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
1. Subject in need of final restoration following molar endodontic therapy 2. Subject age 18 or above -
Exclusion criteria
1. Teeth with remaining symptoms following endodontic therapy 2. Teeth which have experienced endodontic complications to include treated perforations, internal or external resorption, or separated endodontic files. 3. Teeth with exposure of the root canal filling material to the oral environment for greater than two weeks 4. Teeth diagnosed with symptoms of incomplete tooth fracture 5. Teeth with no adjacent or opposing tooth 6. Teeth serving as an abutment for fixed or removable dental prostheses 7. Subjects with uncontrolled bruxism or parafunctional habits 8. Subject has known allergies to any product used in this study 9. Subject will not be available for the study duration of 5 years 10. Subjects with significant untreated dental disease to include periodontitis and rampant caries 11. Women who self-report that they are pregnant or lactating \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Restoration Failure | from delivery of the crown up to 3 years | Restoration failure is scored by visual loss of the crown from the tooth requiring replacement of the study crown with a new crown at any time between delivery and three years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Restoration Loss of Retention | from delivery of crown up to 3 years | Loss of retention is measured as visual detachment or dislodgment of the crown from the tooth without fracture of the crown requiring recementation of the crown. |
| Margin Staining | from delivery of crown up to 3 years | Margin Staining is evaluated as either "0" if there is NO staining at the crown margin where it meets the tooth, or "1" if there IS staining at the crown margin where it meets the tooth. The better outcome is to have NO margin staining. The number of teeth with margin staining are listed below. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDennis Fasbinder, DDS
University of Michigan
Participant flow
Recruitment details
The patient population was selected from current patients under clinical treatment at the University of Michigan Dental Clinics between December 2020 and April 2022. 77 restorations were delivered to 69 patients in the study; 28 males and 41 females. 8 patients received two test restorations. Patients were over 18 years of age, of either gender, and of any ethnic background. 3 participants received 2 EndoOnlays each, 3 received 2 EndoCrowns each, and 2 received 1 EndoOnlay and 1EndoCrown each.
Pre-assignment details
Tree subjects received two endo onlays, which reduced the number of subjects that received an endo onlay to 35. Three subjects received two endo crowns, which reduced the number of subjects that received an endo crown to 36. The total number of subjects is 69, not 71,because two subjects received and endo onlay and an endo crown and thus are double counted.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized age 70 and older | 1 Participants |
| Age, Customized age between 18 and 19 years | 2 Participants |
| Age, Customized age between 20 and 29 years | 8 Participants |
| Age, Customized age between 30 and 39 years | 18 Participants |
| Age, Customized age between 40 and 49 years | 6 Participants |
| Age, Customized age between 50 and 59 years | 11 Participants |
| Age, Customized age between 60 and 69 years | 2 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 69 | 0 / 69 |
| other Total, other adverse events | 0 / 69 | 0 / 69 |
| serious Total, serious adverse events | 0 / 69 | 0 / 69 |
Outcome results
None listed