| CTRI Number |
CTRI/2018/07/014737 [Registered on: 05/07/2018] Trial Registered Prospectively |
| Last Modified On: |
03/07/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical efficacy of crowns fabricated using LuxaCrown. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
DEPEND |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT03160950 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neeraj Gugnani |
| Designation |
Professor |
| Affiliation |
DAV (C) Dental College Yamunanagar |
| Address |
Department of Pedodontics
(Department No. 6)
IInd Floor
DAV (C) Dental College Yamunanagar
Yamunanagar
HARYANA
135001
India |
| Phone |
9416061087 |
| Fax |
|
| Email |
drgugnani18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neeraj Gugnani |
| Designation |
Professor |
| Affiliation |
DAV (C) Dental College Yamunanagar |
| Address |
Department of Pedodontics
(Department No.6) IInd Floor
DAV (C) Dental College Yamunanagar
Yamunanagar
HARYANA
135001
India |
| Phone |
9416061087 |
| Fax |
|
| Email |
drgugnani18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeraj Gugnani |
| Designation |
Professor |
| Affiliation |
DAV (C) Dental College Yamunanagar |
| Address |
Department of Pedodontics
(Department No.6) IInd Floor
DAV (C) Dental College Yamunanagar
Yamunanagar
HARYANA
135001
India |
| Phone |
9416061087 |
| Fax |
|
| Email |
drgugnani18@gmail.com |
|
|
Source of Monetary or Material Support
|
| DMG
Dental Material Gesellschaft mbH
Elbgaustraße 248 22547 Hamburg
Germany |
|
|
Primary Sponsor
|
| Name |
DMG Germany |
| Address |
DMG
Dental Material
Gesellschaft mbH
Hamburg
GERMANY |
| Type of Sponsor |
Other [Dental Materials Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Neeraj Gugnani |
DAV (C) Dental College |
Department of Pedodontics
(Department No.6) IInd Floor
DAV (C) Dental College
Yamunanagar
HARYANA |
9416061087
drgugnani18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of DAV (C) Dental College yamunanagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Broken teeth, RCT treated teeth - indicated for crown fabrication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 mixed automatically by an auto-mix syringe.It is being marketed in India. |
| Comparator Agent |
Nil |
A single arm trial |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 < ½ crown structure remaining will also be selected provided they can be restored with a crown after a conventional Post and core.
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 Miller’s Criteria shall be selected for the purpose of study. |
|
| ExclusionCriteria |
| Details |
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 Miller’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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anatomical form, marginal adaptation, color match, marginal discoloration, surface roughness and secondary caries,Gingival compatibility, plaque retention, Wear and pulp compatibility, Postoperative hypersensitivity |
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 Outcome
|
| Outcome |
TimePoints |
| Patient Satisfaction |
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). |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
05/07/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="6"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background Preservation of the natural human dentition is an important factor in efforts to promote good oral health [2]. Caries and trauma are amongst the leading causes which lead to the loss of dental hard tissues and mandate their restoration for proper functioning [3]. Most of the times, after an endodontic treatment, the remaining tooth structure is weak to withstand the masticatory load and thus requires an extra-coronal restoration. Additionally, whenever the simpler forms of restorations are not effective, crowns may be indicated to restore the form, function and appearance of these teeth [4]. Various materials have been proposed for the crown fabrication like polymethylmethacrylate, porcelain/ceramic and more recently zirconia. Acrylics were initially favored as crown building materials, however, due to their high wear rate, increased susceptibility to staining and poor strength, they were quickly discontinued for permanent crown fabrication, remained limited as a temporization material and thus, other materials for crown fabrication were tested [5]. Mostly Porcelain-fused to-metal (PFM) crowns are considered for repair of damaged or fractured teeth. They are frequently considered as the “gold standard†in prosthetic dentistry [6]. PFM crowns have good mechanical properties, satisfactory esthetic results, and an acceptable biological quality needed for periodontal health. More recently introduced ‘All-ceramic’ and Zirconia crowns also offer excellent strength and close to natural shade matching [7]. These crowns also have some limitations that may limit their use. For example, the esthetic of PFM crowns is limited by the metal framework and the layer of opaque porcelain needed for masking the underlying metal grayish shade [8]. Recently the cost of precious metals has risen markedly making PFM relatively unattractive from an economic standpoint [8]. Furthermore, the zirconia and all ceramic are highly expensive and fabrication of all such crowns require an intensive technique sensitive procedure and multiple visits to the dentist and are usually in service for 10-15 years [9, 10]. It has been observed that the increased cost and technique sensitivity of the crown preparation procedure may be a reason for the patients to defer the crown restoration. However with passing times, a restorable tooth may gradually fracture and may become unrestorable [11].Thus, there has been always a quest to create a crown material which is esthetic, cheap, shows good marginal integrity, is durable and be able to bear the masticatory load without wearing off significantly and may stay in service for as long as possible. Recently, a new material called LuxaCrown has been launched by DMG, Germany. It is a composite based material with improved properties and is claimed by the company to be indicated for ‘crowns’ in permanent teeth. If proved efficacious, these crowns would serve as a ready cost effective alternative in the dentist’s kit as an esthetic material for single visit crown fabrication. Hence, the present study is planned to study the efficacy and safety of the material in providing such crowns to the patients who would be indicated for any permanent crown restorations. The study would be a single arm non-blinded study with intensive follow up for 2 years and then a yearly follow-up for additional 3 years.
Description of the CIP The objective of the Clinical Investigation Plan (CIP) is to provide a full description of the planned clinical trial. The preceding short narrative (Synopsis) introduced the goal of the project and its approach to investigate the durability and safety of full-coverage crowns fabricated with LuxaCrown. A precise description of the study details according to international regulatory guidelines is provided in the sections 2 – 24 of the CIP.
The trial organization is located at Yamunanagar, India. The designated research team will conduct a clinical study to evaluate the durability and safety of full-coverage crowns fabricated with LuxaCrown. This clinical team includes Chief Investigator Dr Neeraj Gugnani Co-investigators: Dr IK Pandit Dr Vijay Singh Dr Viram Dr Monika
Abstract 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). All outcomes will be recorded as per standard scoring criteria. 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 experiencedendodontist. 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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