Clinical Efficacy of Crowns Fabricated Using LuxaCrown

Dental Material Gesellschaft

Status

Unknown

Conditions

Single Crown Restoration

LuxaCrown

Treatments

Device: LuxaCrown

Study type

Interventional

Funder types

Industry

Identifiers

NCT03160950

DEPEND

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

25 to 60 years old

Volunteers

No Healthy Volunteers

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 > ½ crown structure remaining will be selected.
Broken teeth with < ½ 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.