Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04963530 |
| Other study ID # |
186205 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
May 2024 |
Study information
| Verified date |
May 2022 |
| Source |
University of Valencia |
| Contact |
Mª Fernanda Solá Ruiz, Dentistry |
| Phone |
609048198 |
| Email |
m.fernanda.sola[@]uv.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to evaluate the wear produced in the short and medium term by
monolithic zirconia, metal-ceramic and lithium disilicate restorations on the antagonist
natural enamel in patients with fixed prostheses, assessing the factors that may influence
this wear.
The investigators will also analyse whether the wear of the tooth antagonistic to the
different restorations differs significantly with respect to the wear of the natural tooth
(control group). The null hypothesis is that there are no significant differences.
Description:
The study will be carried out on patients who will be candidates for treatment with full
coverage restorations on teeth (single crowns). These crowns will be made of one of the
following materials: monolithic zirconia, lithium disilicate or metal-ceramic, which will be
cemented according to the guidelines defined in the scientific literature.
Inclusion criteria will be: patients in need of full coverage crowns on a first or second
premolar or first or second molar in any arch, over 18 years of age, no contraindications for
dental treatment, good oral hygiene, no periodontal disease or treated periodontal disease,
absence of temporomandibular disorder and/or untreated habits or parafunctions.
The aim of this study is to evaluate the wear produced in the short and medium term by
monolithic zirconia, metal-ceramic and lithium disilicate restorations on the antagonist
tooth in patients with fixed prostheses, assessing the factors that may influence this wear.
The investigators will also analyse whether the wear of the tooth antagonistic to the
different restorations differs significantly with respect to the wear of the natural tooth
(control group). The null hypothesis is that there are no significant differences.
Once the treatment has been completed, the patient must attend routine check-ups in which a
complete intraoral exploration, a scan and data collection for both arches will be carried
out in order to analyse the following variables: wear of the antagonist tooth to ceramic
restorations, wear of the restoration itself and physiological wear of the natural tooth. The
same intervention will be carried out for the duration of the project, at the following time
intervals: baseline (day of cementation of the restoration), 1 month, 6 months and annually.
If an intraoral scanner is not available, silicone impressions will be made, which will be
cast with plaster and scanned extraorally.
The investigators will work with a sample "n" of 75 patients, collected over the next two
years. Depending on the material used to fabricate the restoration, 4 different groups will
be differentiated: monolithic zirconia (group 1), metal-ceramic (group 2), lithium disilicate
(group 3) and natural tooth (control group). The patients will be randomly distributed into
the different groups using the online randomisation software www.alazarinfo.es.
