Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2018-03-19
2024-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LuxaCrown
LuxaCrown
Teeth that would be requiring RCT, would be initially treated by a endodontist using the standardized principles of rotary endodontics.
Restoration using the LuxaCrown as a direct composite crown: In short, the impression material will be loaded with the LuxaCrown material (DMG, Germany). Approx. 0:40 minutes after the start of mixing, the filled impression will be placed in the patient's mouth and will stay there for approx. 1:45 - 2:20 minutes, that is, till the material is partially set. The impression will then be taken out and the material will be allowed to set outside patient's mouth up to approximately 5 minutes after the start of mixing. The Crown will then be finished using a fine buff and pumice, followed by application of Glaze and Bond (DMG, Germany). The preparation will then be cleaned and slightly roughened with a bur or sand blaster at the adhesion sites. The crown fabricated will then be cemented using PermaCem 2.0 luting cement (DMG, Germany).
Interventions
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LuxaCrown
Teeth that would be requiring RCT, would be initially treated by a endodontist using the standardized principles of rotary endodontics.
Restoration using the LuxaCrown as a direct composite crown: In short, the impression material will be loaded with the LuxaCrown material (DMG, Germany). Approx. 0:40 minutes after the start of mixing, the filled impression will be placed in the patient's mouth and will stay there for approx. 1:45 - 2:20 minutes, that is, till the material is partially set. The impression will then be taken out and the material will be allowed to set outside patient's mouth up to approximately 5 minutes after the start of mixing. The Crown will then be finished using a fine buff and pumice, followed by application of Glaze and Bond (DMG, Germany). The preparation will then be cleaned and slightly roughened with a bur or sand blaster at the adhesion sites. The crown fabricated will then be cemented using PermaCem 2.0 luting cement (DMG, Germany).
Eligibility Criteria
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Inclusion Criteria
* 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 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.
25 Years
60 Years
ALL
No
Sponsors
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DMG Dental Material Gesellschaft mbH
INDUSTRY
Responsible Party
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Principal Investigators
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Neeraj Gugnani, Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Pedodontics and Preventive Dentistry, DAV Dental College
Locations
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DAV (C) Dental College Model Town
Yamuna Nagar, Haryana, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DEPEND
Identifier Type: -
Identifier Source: org_study_id
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