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

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.

Study Overview

• Status: Recruiting
• Conditions: LuxaCrown; Single Crown Restoration
• Intervention / Treatment: Device: LuxaCrown

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcus Cebula, Dr.; Phone Number: 232 00494084006; Email: mcebula@dmg-dental.com
• Study Contact Backup: Name: Susanne Effenberger, Dr.; Phone Number: 185 00494084006; Email: seffenberger@dmg-dental.com

Study Locations

• India
  • Haryana
    • Yamunanagar, Haryana, India, 135001
      • Recruiting
      • DAV (C) Dental College Model Town
      • Contact: Inder Kumar Pandit, Dr.; Phone Number: 46 +91 173220804; Email: drpandit3080@gmail.com
      • Contact: Neeraj Gugnani, Dr.; Phone Number: 46 +91 173220804; Email: drgugnani@gmail.com
      • Principal Investigator: Neeraj Gugnani, Dr.
      • Sub-Investigator: Vijay Singh, Dr.
      • Sub-Investigator: Viram Upadhaya, Dr.
      • Sub-Investigator: Shalini Gugnani, Dr.
      • Sub-Investigator: Sugandhi Soni, Dr.
      • Sub-Investigator: Monika Gupta, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: LuxaCrown

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of anatomical form	Anatomical form will be assessed and scored according to Dijken modification of USPHS criteria.	1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of marginal adaptation	Marginal adaptation will be assessed and scored according to Dijken modification of USPHS criteria.	1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of color match	Color match will be assessed and scored according to Dijken modification of USPHS criteria.	1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of marginal discoloration	Marginal discoloration will be assessed and scored according to Dijken modification of USPHS criteria.	1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of surface roughness	Surface roughness will be assessed and scored according to Dijken modification of USPHS criteria.	1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of secondary caries	Secondary caries will be assessed and scored according to Dijken modification of USPHS criteria.	1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of wear	The severity of attrition will be scored as described by Pergamalian	1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of pulpal compatibility	Assessment of the pulpal response by the FDI criteria	1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of plaque index	Plaque index will be assessed and scored according to Sillness and Loe, 1964	1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change of modified papillary bleeding index	Measurement and scoring of modified papillary bleeding index (Barnett et al.)	1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of patient satisfaction	Patient satisfaction will be assessed by FDI criteria.	1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

Collaborators and Investigators

• Sponsor: DMG Dental Material Gesellschaft mbH
• Investigators: Principal Investigator: Neeraj Gugnani, Dr., Department of Pedodontics and Preventive Dentistry, DAV Dental College

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2018
• Primary Completion (ANTICIPATED): March 1, 2021
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (ACTUAL): May 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: DEPEND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No