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CTRI Number  CTRI/2020/01/022801 [Registered on: 16/01/2020] Trial Registered Prospectively
Last Modified On: 14/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Comparison of Preformed Zirconia and Stainless Steel Crowns in Young Permanent Teeth  
Scientific Title of Study
Modification(s)  
Comparative Assessment of the Clinical Efficacy in Preformed Zirconia Crown and Stainless Steel Crown in Permanent Molar Teeth in Pediatric Patients- Randomized Prospective Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhinav Talekar 
Designation  Associate Professor 
Affiliation  MA Rangoonwala College of Dentistry, Camp, 
Address  MA Rangoonwala College of Dentistry, Camp, Pune

Pune
MAHARASHTRA
411001
India 
Phone  9503079151  
Fax    
Email  drabhinavtalekar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhinav Talekar 
Designation  Associate Professor 
Affiliation  MA Rangoonwala College of Dentistry, Camp, 
Address  406, 2nd Floor ,Department of Peditric dentistry, MA Rangoonwala College of Dentistry, Camp, Pune

Pune
MAHARASHTRA
411001
India 
Phone  9503079151  
Fax    
Email  drabhinavtalekar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhinav Talekar 
Designation  Associate Professor 
Affiliation  MA Rangoonwala College of Dentistry, Camp, 
Address  406, 2nd Floor, department of Pediatric Dentistry,MA Rangoonwala College of Dentistry, Camp, Pune

Pune
MAHARASHTRA
411001
India 
Phone  9503079151  
Fax    
Email  drabhinavtalekar@gmail.com  
 
Source of Monetary or Material Support  
Nusmile Texas 3315 W 12th Street | Houston, TX | 77008 USA 
 
Primary Sponsor  
Name  Dr Abhinav Talekar 
Address  M A RAngoonwala Dental College Pune 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr AbhinavTalekar  M A Rangoonwala college of dental science and research centre, Camp Pune 411001  406, 2nd Floor, Deparrtment of Pediatric Dentistry, MA Rangoonwala College of Dentistry, Camp, Pune
Pune
MAHARASHTRA 
9503079151

drabhinavtalekar@gmail.com 
Dr AbhinavTalekar  Talekar Children Dental Care  off no 19 , Kumar Pavilion, East Street , Camp, Pune
Pune
MAHARASHTRA 
9503079151

drabhinavtalekar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE OF M.C.E. SOCIETY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Stainless Steel Crowns  3m Espe USA 
Comparator Agent  zirconia   3 m Espe. Nusmile USA 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
1) Requirement of placement of crowns on permanent molar after endodontic treatment
2) Teeth required for multi surface restoration followed by crown
3) Permanent second molar is erupting
4) Opposite teeth present
 
 
ExclusionCriteria 
Details  Exclusion criteria:
1) Teeth with poor prognosis
2) Patient refused to participate
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Both crowns are having equal clinical performance.
Methhodology: MOdified USPHS criteria 
One week, 3 months, 6 months, 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Zironia crowns do not affect eruption of second molar
Methodology:
Intraoral Periapical Radiograph
Clinical Picture 
One week, 3 months, 6 months, 12 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "37"
Final Enrollment numbers achieved (India)="37" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2020 
Date of Study Completion (India) 25/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

                                            â€œClinical assesment of permanent molar zirconia crowns”

 

Aims:

1)   to assess clinical efficacy of permanent molar crowns

2)   to assess the eruption path of second molar

3)   to  check clinical time required for placement of crown

4)   to assess the opposite teeth wear over the period of time

 Methodology:Inclusion criteria:

1)   requirement of placement  of crowns on permanent molar after endodontic treatment

2)   teeth required for multisurface restoration followed by crown

3)   permanent second molar is erupting

4)   opposite teeth present

Exclusion criteria:

1)   teeth with poor prognosis

2)   patient refused to participate

 Procedure:

Total no of teeth 50  prrmanent molar crowns ( nusmile zirconia

1)   preoperative x ray

2)   local anesthesia

3)   rubber dam application

4)   tooth preparation

5)   try in with pink crown

6)   check bite

7)   cementation with resin gic (nusmile biocem)

8)   follow up with (clinical pictures and x rays)

A)   3 months

B)  6 months

C)    12 months

9)   3d scan of impression with opposite teeth with every follow up 

Materials required:

1)   local anesthesia

2)   rubber dam kit

3)   burs

Materials required from company:

1)   total 50 number of zirconia crowns

2)   nusmile biocem gic

 

 

 

 


 
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