Clinical efficacy of crowns fabricated using LuxaCrown.
- Conditions
- Health Condition 1: null- Broken teeth, RCT treated teeth - indicated for crown fabrication
- Registration Number
- CTRI/2018/07/014737
- Lead Sponsor
- DMG Germany
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
i. Healthy adult patients with age range of 25 - 60 years.
ii. 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
a. Extensive coronal / structural broken tooth due to caries or trauma
b. Teeth undergone successful endodontic therapy (no signs of failure- asymptomatic, no tenderness on percussion, healthy associated soft tissue)
c. 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.
iii. Broken teeth with > 1/2 crown structure remaining will be selected.
iv. 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.
v. Patients with good Occlusal Contact will be selected.
vi. Patients who would be giving the Signed Informed Consent shall only be enrolled for the study.
vii. Only the teeth showing mobility grade 0 and 1 as per Millerâ??s Criteria shall be selected for the purpose of study.
Exclusion Criteria
i. Patients showing signs of bruxism shall not be selected. History of bruxism and wear facets will be checked for ruling out the bruxism habit.
ii. Patients with severe periodontal disease, that involves all teeth or tooth indicated for crown fabrication shall not be included in the study.iii. Any clinical or radiographic sig or symptom indicative of periapical or furcation involvement.
iv. If the tooth indicated for crown fabrication depicts a mobility grade 2 or 3 as per Millerâ??s criteria, it shall be excluded from the study.
v. Any systemic illness, pregnancy or history of allergy to dental fillings/materials shall also be excluded.
vi. 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.
vii. Hypoplastic / malformed teeth will not be selected for the purpose of study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anatomical form, marginal adaptation, color match, marginal discoloration, surface roughness and secondary caries,Gingival compatibility, plaque retention, Wear and pulp compatibility, Postoperative hypersensitivityTimepoint: The patients will be followed intensively for first 2 years (1 week, 3, 6, 12, 18 and 24 months) and then yearly for additional three years (36, 48 and 60 months).
- Secondary Outcome Measures
Name Time Method Patient SatisfactionTimepoint: The patients will be followed intensively for first 2 years (1 week, 3, 6, 12, 18 and 24 months) and then yearly for additional three years (36, 48 and 60 months).