Decayed Tooth, Fractured Tooth, Unsatisfactory Restoration of Tooth
Conditions
Keywords
CAD/CAM, Ceramic, Crown
Brief summary
This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.
Detailed description
The study will be composed of two groups of 50 crowns placed in adult patients that have been identified as requiring at least one crown on a posterior tooth. A maximum of two crowns per patient will be completed. All the crowns will be made from the same high strength ceramic material (Celtra Duo/Dentsply Sirona). The two groups of crowns will be made using two different processes to create the surface texture and finish for the crown. One group of Celtra Duo crowns (Group 1) will be glaze-fired in a porcelain oven and the second group (Group 2) will be hand-polished. All the crowns will be cemented using two adhesive techniques. All of the oven-fired, glazed crowns will be cemented using the self-etching, self-adhesive resin cement technique (Calibra Universal Cement/Dentsply). All of the hand polished crowns will be cemented using an adhesive bonding technique using Prime & Bond Elect (Dentsply) with a dual cured resin cement (Calibra Ceram/Dentsply). The crowns are planned to be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. At each appointment an examination of the crown will be completed as well as clinical photographs, an intraoral digital scan, and impression of the crown.
Interventions
DEVICECeltra Duo
Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Sponsors
Dentsply Sirona Inc.
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
Final surface fabrication was not identified in the treatment process until the crown was milled.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar * reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration * Teeth to be vital and asymptomatic prior to treatment * No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth.
Exclusion criteria
* Devital or sensitive teeth * Teeth with prior endodontic treatment of any kind * Teeth with a history of direct or indirect pulp capping procedures * Patients with significant untreated dental disease to include periodontitis and rampant caries * Pregnant or lactating women * Patients with a history of allergies to any of the materials to be used in the study * Patients unable to return for the recall appointments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crown Failure | from delivery of the crown up to 3 years | Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and three years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Crown Loss of Retention | 3 years | Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown. |
| Tooth Sensitivity | 3 years | Tooth Sensitivity is evaluated as either 0 if the subject reports that there is NO sensitivity for the tooth with the study crown, or 1 if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure. The better outcome is to have NO tooth sensitivity. The number of teeth with tooth sensitivity are listed below. |
| Margin Staining | from delivery of the 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
Participant flow
Pre-assignment details
Recall at 5 years not funded by sponsor, therefore data not collected up to 5 years
Participants by arm
| Arm | Count |
|---|---|
| Glazed Fired, Calibra Céram Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo. | 41 |
| Glazed Fired, Calibra Céram Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo. | 50 |
| Hand Polished, Calibra Universal Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo. | 32 |
| Hand Polished, Calibra Universal Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo. | 50 |
| Total | 173 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 2 Years | Lost to Follow-up | 1 | 0 |
| 3 Years | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Glazed Fired, Calibra Céram | Hand Polished, Calibra Universal | Total |
|---|---|---|---|
| Age, Customized | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 26 Participants | 23 Participants | 49 Participants |
| Sex: Female, Male Male | 15 Participants | 9 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 32 |
| other Total, other adverse events | 0 / 41 | 0 / 32 |
| serious Total, serious adverse events | 0 / 41 | 0 / 32 |
Outcome results
Primary
Crown Failure
Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and three years.
Time frame: from delivery of the crown up to 3 years
Population: teeth restored with crowns
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glazed Fired, Calibra Céram | Crown Failure | 5 crowns |
| Hand Polished, Calibra Universal | Crown Failure | 5 crowns |
Secondary
Crown Loss of Retention
Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.
Time frame: 3 years
Population: number of crowns
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glazed Fired, Calibra Céram | Crown Loss of Retention | 2 crowns |
| Hand Polished, Calibra Universal | Crown Loss of Retention | 0 crowns |
Secondary
Margin Staining
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.
Time frame: from delivery of the crown up to 3 years
Population: number of crowns
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glazed Fired, Calibra Céram | Margin Staining | 2 crowns |
| Hand Polished, Calibra Universal | Margin Staining | 2 crowns |
Secondary
Tooth Sensitivity
Tooth Sensitivity is evaluated as either 0 if the subject reports that there is NO sensitivity for the tooth with the study crown, or 1 if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure. The better outcome is to have NO tooth sensitivity. The number of teeth with tooth sensitivity are listed below.
Time frame: 3 years
Population: number of teeth with crown
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glazed Fired, Calibra Céram | Tooth Sensitivity | 0 Teeth |
| Hand Polished, Calibra Universal | Tooth Sensitivity | 0 Teeth |