No registrations found.
ID
Source
Brief title
Health condition
Caries, periodontal disease, pulpal disease, fracture
Sponsors and support
Intervention
Outcome measures
Primary outcome
Indirect restorations with IDS at preparation are likely to survive on the long-term.
Secondary outcome
Restorations are likely to present with some degradation in time due to intra-oral function. Quality of survival will be measured by the use of certain variables and USPHS criteria on digital photographs and X-rays.
Background summary
Large sized cavities can be restored using partial indirect ceramic restorations since these restorations can properly restore the morphology and function of the tooth. However, lithium disilicate restorations are prone to bulk fracture, chipping and adhesive problems. Adhesive problems are combatted by the use of Immediate Dentin Sealing (IDS). IDS has proven to significantly increase the fracture strength of lithium disilicate restorations.
Not many long term clinical knowledge is present on the survival and performance of these restorations in combination with IDS. Therefore, this clinical trial investigates the survival rate of partial indirect lithium disilicate restorations in conjunction with IDS.
Approximately 2000-3000 restorations will be included in the study. The primary outcome will be the survival of the lithium disilicate restorations. Data will be collected from digital light photo’s, X-rays and patient files. These are part of regular dental care and therefore no extra burden for the patient. This study will be registered as a non-objection study. Data will be analyzed using a Kaplan-Meier survival analysis with Log rank tests and Cox regression multi-level analysis with paired data (with frailty model). Overall survival rates after 7-9 years of evaluation are expected to be over 90%. Moreover, this study might be able to identify the influence of risk factors and patient factors on survival.
Study objective
Overall survival rates after 7-9 years of evaluation will be over 90%.
Study design
Initial at baseline, at every check up (every 6 months), up to 15 years of follow-up
Intervention
Indirect restoration of ceramic material with application of Immediate Dentin Sealing at preparation.
Rijkje Bresser
0613373723
r.a.bresser@student.rug.nl
Rijkje Bresser
0613373723
r.a.bresser@student.rug.nl
Inclusion criteria
All patients who received indirect partial lithium disilicate restoration from 2008 are eligible for inclusion. Patients have to be at least 18 years of age and have to be physically and psychologically able to tolerate restorative procedures. IDS must be applied at every preparation. Moreover, the candidate is a patient at Buijs Tandartsen.
Exclusion criteria
Not willing to enroll in the study, changing dentist or having moved to another city or dental practice after restoration.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9026 |
| Other | METC UMCG : METC202000588 |