LuxaCrown Clinical Trial
Official title:
Evaluating the Longevity and Safety of Full-coverage Crowns Fabricated With LuxaCrown Over a Period of 5 Years in 25-60 Year Old Indian Population: An Uncontrolled Trial
A single arm non-blinded study is planned to evaluate the durability of the crowns fabricated
using a novel composite based material, LuxaCrown (DMG, Germany). The durability of these
crowns will be assessed for anatomical form, marginal adaptation, color match, marginal
discoloration, surface roughness, secondary caries, pulpal compatibility, plaque index and
modified papillary bleeding index with intensive follow up for 2 years (at 1 week, 3rd, 6th,
12th, 18th and 24th month), and then a yearly follow-up for additional 3 years (at 36th, 48th
and 60th month).
A total of 50 patients will be selected and one tooth per subject will be included. For the
purpose of study only the healthy adult patients with age range of 25 - 60 years who would be
requiring Single crown restoration in the permanent anterior / posterior teeth, either due to
caries, pulpal involvement or trauma, will be selected. Teeth that require endodontic
treatment shall be included in the study only after successful endodontic therapy has been
completed by an experienced endodontist. For broken teeth, only the teeth with > 1/2 crown
structure remaining or in case of teeth with <1/2 crown structure fractured that can be
restored with conventional post and core will be selected. In general, patients with bruxism,
or with severe periodontal disease, mobility grade 2 or 3 shall be excluded from the study.
n/a