Clinical trial NCT03160950: Clinical Efficacy of Crowns Fabricated Using LuxaCrown
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: LuxaCrown
Single Crown Restoration
Lead sponsor: DMG Dental Material Gesellschaft mbH
Sponsor class: INDUSTRY
First posted: 2017-05-19
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of anatomical form
timeFrame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
measure: Change of marginal adaptation
timeFrame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
measure: Change of color match
timeFrame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
measure: Change of marginal discoloration
timeFrame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
measure: Change of surface roughness
timeFrame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
measure: Change of secondary caries
timeFrame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
measure: Change of wear
timeFrame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
measure: Change of pulpal compatibility
timeFrame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
measure: Change of plaque index
timeFrame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
measure: Change of modified papillary bleeding index
timeFrame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Secondary outcomes:
measure: Change of patient satisfaction
timeFrame: 1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Other outcomes:
Locations:
city: Yamunanagar
country: India
facility: DAV (C) Dental College Model Town
state: Haryana
Study officials:
affiliation: Department of Pedodontics and Preventive Dentistry, DAV Dental College
name: Neeraj Gugnani, Dr.
role: PRINCIPAL_INVESTIGATOR
References: