Clinical Efficacy of Crowns Fabricated Using LuxaCrown

  • STATUS
    Recruiting
  • End date
    Mar 22, 2024
  • participants needed
    50
  • sponsor
    DMG Dental Material Gesellschaft mbH
Updated on 5 March 2022

Summary

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.

Details
Condition LuxaCrown, Single Crown Restoration
Treatment LuxaCrown, LuxaCrown
Clinical Study IdentifierNCT03160950
SponsorDMG Dental Material Gesellschaft mbH
Last Modified on5 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy adult patients with age range 25 - 60 years
Only the patients who would be requiring Single crown restoration in the permanent anterior / posterior teeth will be selected for the purpose of study. Single crowns are usually indicated in either of the following conditions
Extensive coronal / structural broken tooth due to caries or trauma
Teeth undergone successful endodontic therapy (no signs of failure- asymptomatic, no tenderness on percussion, healthy associated soft tissue)
Microdonts
Teeth that require endodontic treatment shall be included in the study only
after successful endodontic therapy has been completed by an experienced
endodontist. The success of the endodontic therapy shall be evaluated using
the standardized clinical and radiographic criteria by the endodontist
Broken teeth with > crown structure remaining will be selected
Broken teeth with < crown structure remaining will also be selected provided they can be restored with a crown after a conventional Post and core
Patients with good Occlusal Contact will be selected
Patients who would be giving the Signed Informed Consent shall only be enrolled for the study
Only the teeth showing mobility grade 0 and 1 as per Miller's Criteria shall be selected for the purpose of study

Exclusion Criteria

Patients showing signs of bruxism shall not be selected. History of bruxism and wear facets will be checked for ruling out the bruxism habit
Patients with severe periodontal disease, that involves all teeth or tooth indicated for crown fabrication shall not be included in the study
Any clinical or radiographic sig or symptom indicative of periapical or furcation involvement
If the tooth indicated for crown fabrication depicts a mobility grade 2 or 3 as per Miller's criteria, it shall be excluded from the study
History of any systemic illness, pregnancy or history of allergy to dental fillings/materials shall also be excluded
Teeth with fracture of crown en-masse (Ellis Class VIII) fracture or which are badly mutilated such that a very minimal or No coronal structure is remaining will be excluded
Hypoplastic / malformed teeth will not be selected for the purpose of study
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