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CTRI Number  CTRI/2021/03/031937 [Registered on: 12/03/2021] Trial Registered Prospectively
Last Modified On: 12/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparative evaluation of clinical success of Pre-veneered Stainless steel crowns, Cellulose crowns and two types of Zirconia Crowns in primary anterior teeth. 
Scientific Title of Study   Comparative evaluation of clinical success of Pre-veneered Stainless steel crowns, Cellulose crowns and two types of Zirconia Crowns in primary anterior teeth – A Prospective randomized follow up clinical study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amol Patil 
Designation  Assistant Professor 
Affiliation  MA Rangoonwala college of dental science and research centre 
Address  406,Department of pediatric and preventive dentistry,MA Rangoonwala Dental College, Camp, Pune

Pune
MAHARASHTRA
411001
India 
Phone  9561042279  
Fax    
Email  amolpatil2526@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Aliya Ershad 
Designation  Post graduate student 
Affiliation  MA Rangoonwala college of dental science and research centre 
Address  406,Department of pediatric and preventive dentistry,MA Rangoonwala Dental College, Camp, Pune

Pune
MAHARASHTRA
411001
India 
Phone  8291593232  
Fax    
Email  aliyaershad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shikha Choubey 
Designation  Reader 
Affiliation  MA Rangoonwala college of dental science and research centre 
Address  406.Department of pediatric and preventive dentistry,MA Rangoonwala Dental College, Camp, Pune

Pune
MAHARASHTRA
411001
India 
Phone  9827248806  
Fax    
Email  shikhachoubey@hotmail.com  
 
Source of Monetary or Material Support  
M A Rangoonwala college of dental science and research centre. 
 
Primary Sponsor  
Name  self funded 
Address  MA Rangoonwala college of dental science and research centre 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aliya Ershad  MA Rangoonwala college of dental science and research centre  406,department of pediatric and preventive dentistry,MA Rangoonwala college of dental science and research centre,Azam campus, pune
Pune
MAHARASHTRA 		 8291593232

aliyaershad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics ccommittee of MCE Society  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children in the age group of 3 years to 6 years requiring full coverage restoration on their primary anterior teeth. 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ES White crowns  SEATTLE, WA 
Comparator Agent  KidsE Crown  ODS Cad Cam centre, parel, Mumbai 
Comparator Agent  NU Smile Crowns  TEXAS USA 
Comparator Agent  Strip Crown  3M ESPE,2510 Convay Avenue, USA 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1)Parents willing to give consent.
2)Vital Primary teeth indicated for full coverage restoration.
3)Frankel’s positive and definitely positive patients
4)Children aged between 3 to 6 years.
5)No significant medical history.
6)Adequate root support should be present.
 
 
ExclusionCriteria 
Details  1)Non-vital primary anterior teeth.
2)Traumatized primary anterior teeth.
3)Children with special needs.
4)Inadequate root length.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1)To compare clinical success of Pre-veneered, Cellulose crowns and two types of Zirconia Crowns under following criteria:
2)Duration (Time required for placement of Pre-veneered Stainless Steel Crowns, Cellulose crowns and two types of Zirconia Crowns).
3)Colour match (with natural teeth using Casmatch).
4)Colour stability (Over a period of time, change in colour of crown due to plaque retention).
5)Occlusion (bilateral harmony after placement of crown).
 		 1.To compare clinical success of Pre-veneered, Cellulose crowns and two types of Zirconia Crowns under following criteria:
2)Duration (Time required for placement of Pre-veneered Stainless Steel Crowns, Cellulose crowns and two types of Zirconia Crowns).
3)Colour match (with natural teeth using Casmatch).
4)Colour stability (Over a period of time, change in colour of crown due to plaque retention).
5)Occlusion (bilateral harmony after placement of crown).
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare, gingival health of a patient after using Pre-veneered Stainless Steel crowns, Cellulose crowns and two types of Zirconia Crowns.
 		 nil 
To compare parent’s acceptance for Pre-veneered Stainless Steel Crowns, Cellulose crowns and two types of Zirconia Crowns.  nil 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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   N/A 
Date of First Enrollment (India)   20/03/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aliyaershad@gmail.com].

  6. For how long will this data be available start date provided 10-03-2021 and end date provided 10-03-2023?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Study Design: Prospective Randomized clinical study.

Study setting: This is an in-vivo study that will be conducted to evaluate and compare clinical success of Pre-veneered Stainless Steel Crowns, Cellulose crowns and two types of Zirconia Crowns.

Study Population: The patients visiting the Department of Pediatric and Preventive Dentistry in a college of Western Maharashtra.

Sample Size: The study will be carried out on 32 teeth requiring full coverage restoration.

Appropriate Sampling technique: Selection of teeth will be done by lottery method. All the sample will be distributed into four groups.

                     Study Place: Western Maharashtra.

               Study Period: 12 months.

                Method of selection of study subjects:

  Inclusion Criteria:

 Parents willing to give consent.

Vital Primary teeth indicated for full coverage restoration.

Frankel’s positive and definitely positive patients

Children aged between 3 to 6 years.

No significant medical history.

Adequate root support should be present.

  Exclusion Criteria:

Non-vital primary anterior teeth.

Traumatized primary anterior teeth.

Children with special needs

Inadequate root length.

 

Appropriate study instruments:

 Mouth mirror

Probe

Cotton rolls and gauzes

Local anaesthesia with adrenaline(1:2,00,000)

Kids E Crown (ODS Cad Cam centre, parel, Mumbai.)

Nu-Smile crown (TEXAS, USA)

ES White crown (SEATTLE, WA)

Strip crown (3M ESPE,2510 Convay Avenue, USA)

Resin- modified cement

Burs and Hand piece

 Methods of Data collection:

After obtaining ethical clearance from institutional ethics committee, the baseline data will be collected on the basis of inclusion criteria. The 32 samples will be randomly divided into four groups,8 teeth each as follows:

Group A: primary teeth with kids-e-crowns. (ODS Cad Cam centre, parel, Mumbai.)

Group B: primary teeth with Nu-smile crowns. (TEXAS, USA)

Group C: primary teeth with ES White crowns. (SEATTLE, WA)

Group D: primary teeth with Strip crowns (3M ESPE,2510 Convay Avenue,USA)

Group A, Group B ,Group C and Group D

A complete case history of the patient will be recorded.

Radiographs and Photographs will be taken.

Oral prophylaxis will be performed.

Teeth requiring full coverage restoration will be selected and isolated.

A stopwatch will be used to measure time taken for the procedure.

After anaesthesia execution, the crown size selection will be done.

According to the manufacturing instructions, tooth preparation will be done and occlusion will be assessed. Prepared tooth should be free from the blood, saliva, residues prior to crown cementation.

Resin cement will be employed for luting.

 After cementation, the crown surface is cleaned and flossing will be done in the interdental area to remove excess cement.

Post-operative radiographs will be recorded.

The samples will be assessed as follows:

1.      Crown assessment:

Clinical

Radiographical

2.      Patient and parent satisfaction according to USPHS criteria.

3.      Occlusion

4.      The color match will be checked by Casmatch system on each recall

The patient will be recalled after 1 month, 3 month, 6 month, 9 month and 12 month.

 
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