Dental Caries, Dental Leakage, Pulp Disease, Dental
Conditions
Brief summary
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.
Interventions
DEVICEDental prosthesis
Replacement of missing tooth structure using Lithium disilicate porcelain
DEVICEDental crown
Replacement og missing tooth structure using monolithic zirconia
DEVICEHybrid ceramic
Restroration of endodontically treated teeth using hybrid ceramic
Sponsors
University of Jordan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
All ceramic materials will be assigned randomly by research assistant who has randomised tables generated by a statistician
Intervention model description
Three different ceramic types for restoration of endodontically treated teeth
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Root canal treated molars with significant loss of tooth structure * Supra-gingival margins * Teeth scheduled for cuspal-covering indirect restorations
Exclusion criteria
* Teeth with extensive cracks or fractures * Teeth with deep subgingival margins * Non-functional teeth (no opposing dentition) * Teeth with advanced periodontitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival of Dental Prosthesis | 24 months | The endocrowns (the dental prosthesis studied) were assessed after 24 months. Those that were functional and without any symptoms were considered surviving. |
Countries
Jordan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 20 |
| 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 | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Monolithic Zirconia | Hybrid Ceramic | Total | Lithium Disilicate |
|---|---|---|---|---|
| Age, Continuous | 38.1 years STANDARD_DEVIATION 14.9 | 33.4 years STANDARD_DEVIATION 11.2 | 34.1 years STANDARD_DEVIATION 12.6 | 30.8 years STANDARD_DEVIATION 10.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment Jordan | 20 participants | 20 participants | 20 participants | 20 participants |
| Sex: Female, Male Female | 13 Participants | 11 Participants | 39 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 21 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 3 / 20 | 2 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Lithium Disilicate | Survival of Dental Prosthesis | 19 Teeth |
| Monolithic Zirconia | Survival of Dental Prosthesis | 14 Teeth |
| Hybrid Ceramic | Survival of Dental Prosthesis | 17 Teeth |