MedTrace Logo

Clinical Efficacy of Crowns Fabricated Using LuxaCrown

NCT03160950 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-07-16

No results posted yet for this study

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.

Conditions

  • LuxaCrown
  • Single Crown Restoration

Interventions

DEVICE

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).

Sponsors & Collaborators

  • DMG Dental Material Gesellschaft mbH

    lead INDUSTRY

Principal Investigators

  • Neeraj Gugnani, Dr. · Department of Pedodontics and Preventive Dentistry, DAV Dental College

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-19
Primary Completion
2021-03-31
Completion
2024-03-31

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03160950 on ClinicalTrials.gov