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Clinical efficacy of crowns fabricated using LuxaCrown.

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 - DEPEND

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/014737
Enrollment
50
Registered
2018-07-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Broken teeth, RCT treated teeth - indicated for crown fabrication

Interventions

Intervention1: Luxacrown: LuxaCrown is a self-curing composite for the fabrication of semi-permanent crowns and bridges that are cemented with a permanent or temporary luting cement. The material is m

Sponsors

DMG Germany
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 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

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

India

Contacts

Public ContactDr Neeraj Gugnani

DAV (C) Dental College Yamunanagar

drgugnani18@gmail.com9416061087

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026