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Restoration of endodontically treated teeth requires a means to protect the cusps from the wedging forces of occlusion. When there is extensive loss of tooth structure, cuspal coverage is warranted. Usually this is in the form of indirect restoration. Traditionally, full coverage crowns have been used which would require further removal of sound tooth structure. Recently, adhesive alternatives have been introduced which allow for conservation of tooth structure.
Different materials can be used for this purpose. The evidence on the long-term survival of these materials is scarce. This study aims to investigate the short and medium-long term survival rate of these prostheses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithium disilicate | Active Comparator | Lithium disilicate: a type of ceramic material used to make a dental prosthesis that replaces missing tooth structure following root canal treatment. Other names might include: E-max crowns, computer-aided design and computer-aided manufacturing (CAD CAM) crowns |
|
| Monolithic zirconia | Active Comparator | Monolithic zirconia: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Zolid crown, Bruxzir, Bretau, CAD CAM crowns |
|
| Hybrid ceramic | Active Comparator | Hybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental prosthesis | Device | Replacement of missing tooth structure using Lithium disilicate porcelain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival of Dental Prosthesis | The endocrowns (the dental prosthesis studied) were assessed after 24 months. Those that were functional and without any symptoms were considered surviving. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University Hospital | Amman | 11831 | Jordan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lithium Disilicate | Lithium disilicate: a type of ceramic material used to make a dental prosthesis that replaces missing tooth structure following root canal treatment. Other names might include: E-max crowns, computer-aided design and computer-aided manufacturing (CAD CAM) crowns Dental prosthesis: Replacement of missing tooth structure using Lithium disilicate porcelain |
| FG001 | Monolithic Zirconia | Monolithic zirconia: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Zolid crown, Bruxzir, Bretau, CAD CAM crowns Dental crown: Replacement og missing tooth structure using monolithic zirconia |
| FG002 | Hybrid Ceramic | Hybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramic |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lithium Disilicate | Lithium disilicate: a type of ceramic material used to make a dental prosthesis that replaces missing tooth structure following root canal treatment. Other names might include: E-max crowns, computer-aided design and computer-aided manufacturing (CAD CAM) crowns Dental prosthesis: Replacement of missing tooth structure using Lithium disilicate porcelain |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survival of Dental Prosthesis | The endocrowns (the dental prosthesis studied) were assessed after 24 months. Those that were functional and without any symptoms were considered surviving. | Posted | Count of Units | Teeth | 24 months | Teeth | Teeth |
|
24 months
Debonding, fracture, poor appearance, or if the tooth was deemed non-restorable during the 24-month observation period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lithium Disilicate | Lithium disilicate: a type of ceramic material used to make a dental prosthesis that replaces missing tooth structure following root canal treatment. Other names might include: E-max crowns, computer-aided design and computer-aided manufacturing (CAD CAM) crowns Dental prosthesis: Replacement of missing tooth structure using Lithium disilicate porcelain |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Debonding | Product Issues | Systematic Assessment | Endocrown/ dental prosthesis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ahmad El-Ma'aita | University of Jordan | +9626535 5000 | a.maaita@ju.edu.jo |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2018 | Nov 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D003731 | Dental Caries |
| D003763 | Dental Leakage |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D017001 | Tooth Demineralization |
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| ID | Term |
|---|---|
| D017266 | Dental Prosthesis |
| D003442 | Crowns |
| ID | Term |
|---|---|
| D011476 | Prosthodontics |
| D003813 | Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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Three different ceramic types for restoration of endodontically treated teeth
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All ceramic materials will be assigned randomly by research assistant who has randomised tables generated by a statistician
| Dental crown | Device | Replacement og missing tooth structure using monolithic zirconia |
|
|
| Hybrid ceramic | Device | Restroration of endodontically treated teeth using hybrid ceramic |
|
|
| BG001 | Monolithic Zirconia | Monolithic zirconia: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Zolid crown, Bruxzir, Bretau, CAD CAM crowns Dental crown: Replacement og missing tooth structure using monolithic zirconia |
| BG002 | Hybrid Ceramic | Hybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramic |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Hybrid Ceramic | Hybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramic |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Monolithic Zirconia | Monolithic zirconia: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Zolid crown, Bruxzir, Bretau, CAD CAM crowns Dental crown: Replacement og missing tooth structure using monolithic zirconia | 0 | 20 | 0 | 20 | 3 | 20 |
| EG002 | Hybrid Ceramic | Hybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns Hybrid ceramic: Restroration of endodontically treated teeth using hybrid ceramic | 0 | 20 | 0 | 20 | 2 | 20 |
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| Male |
|