An observational study in Partial Indirect Restoration, Clinical Study and Adhesion, sponsored by University Medical Center Groningen. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-03.
Sponsored by University Medical Center Groningen · Observational
Background: Nowadays, tissue preserving, aesthetically high-quality and sustainable dentistry is more and more becoming the standard way of treatment. To reach those standards, one of the treatment options is applying a partial indirect restoration made by glass ceramics using immediate dental sealing (IDS). Using IDS, a protocol is followed to applicate a dentin bonding agent to freshly cut dentin when it is exposed during tooth preparation for indirect restorations (inlays/onlays, crowns). The preparation made for partial restorations is minimal invasive. Glass ceramic restorations have very high survival rates (90 to 100% after five years) (Morimoto et al., 2016) and glass ceramic mimics the color and structure of the tooth very well.
This kind of treatment is gaining interest and increasingly applied however little information is available on the long-term effects when multiple general practitioners apply these restorations.
Objectives: The main goal of this study is to evaluate partial posterior ceramic restorations with the application of an immediate dentin sealing (IDS) performed by various practitioners.
Study design and population:
Twenty dental practitioners, who followed a course on making ceramic partial restorations using IDS, will be asked to include patients for this study. The dental practitioners are being asked to share their data (occlusal light photo's, impression and x-rays) of twenty-five restorations they make after having the course. Restorations of individuals with a minimum age of 18 will be included. The information from pictures and impressions will be evaluated.
Items to evaluate
The practitioners will be interviewed to get to know in what circumstances they do their treatment. Items that are discussed are:
Initial data (gathered directly after treatment) will be evaluated looking at:
Follow up data will be evaluated looking at:
Outcome: Failures (fracture, de-bonding, secondairy cariës, endodontic problems) are the main outcome measurements.
Description and estimation of the load and risk for the subjects:
No extra intervention is performed. The dental practitioners will provide their data (i.e. impressions, occlusal light photo's) and these will be evaluated by the researchers. Follow up data will be gathered from X-rays already made for periodical oral examination (taking the caries risk into account). Summarizing, there is no extra load or risk for the patients.
Studie design Prospective practice-based research, multicenter.
241 studies on the registry are indexed under Tissue Adhesions; 29 are open to participants now.
This study's planned enrollment of 200 is above the median of 146 across 49 observational studies indexed under Tissue Adhesions.
Browse Tissue Adhesions studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Ten different dentists will ask patients (who have been indicated and agreed to have an indirect restoration) if they would like to be part of this study. Taking possible drop-out into account, the practitioners are asked to include twenty patients each (total n=200).
Exclusion Criteria:
Dental restorative treatment
Survival and Succes
Time frame: 5 years
Plan to share: Undecided
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University Medical Center Groningen