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CTRI Number  CTRI/2022/10/046640 [Registered on: 19/10/2022] Trial Registered Prospectively
Last Modified On: 08/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Caps for milk teeth  
Scientific Title of Study   Comparative assessment of clinical efficacy of various types of crowns for primary teeth – A prospective randomized parallel group follow up study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Atharva Choudhary 
Designation  Post-Graduation Student 
Affiliation  M.A. Rangoonwala College of Dental Science and Research Center 
Address  M A Rangoonwala College of Dental Science and Research Centre,Azam Campus 2390B, K.B, Hidayatulla Rd, Camp,Pune

Pune
MAHARASHTRA
411001
India 
Phone  9764553222  
Fax    
Email  dr.atharvachoudhary@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhinav L Talekar 
Designation  Post-Graduation Guide 
Affiliation  M.A. Rangoonwala College of Dental Science and Research Center 
Address  M A Rangoonwala College of Dental Science and Research Centre,Azam Campus 2390B, K.B, Hidayatulla Rd, Camp,Pune

Pune
MAHARASHTRA
411001
India 
Phone  9503079151  
Fax    
Email  drabhinavtalekar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Atharva Choudhary 
Designation  Post-Graduation Student 
Affiliation  M. A. Rangoonwala College of Dental Science and Research Centre 
Address  M A Rangoonwala College of Dental Science and Research Centre,Azam Campus 2390B, K.B, Hidayatulla Rd, Camp,Pune

Pune
MAHARASHTRA
411001
India 
Phone  9764553222  
Fax    
Email  dr.atharvachoudhary@gmail.com  
 
Source of Monetary or Material Support  
M A Rangoonwala College Of Dental Science & Research Centre,Azam Campus 2390-B, K.B, Hidayatulla Rd, Camp, Pune, Maharashtra 411001 
 
Primary Sponsor  
Name  SelfAtharva Choudhary 
Address  M A Rangoonwala College Of Dental Science & Research Centre,Azam Campus 2390B, K.B, Hidayatulla Rd, Camp, Pune, Maharashtra 411001 
Type of Sponsor  Other [College Of Dental Science and Research Centre] 
 
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 
Dr Atharva A Choudhary  M A Rangoonwala College Of Dental Science & Research Centre  Room No. 406,Deparetment of pediatric and preventive dentistry,M.A.Rangoonwala College of Dental Scienes & ResearchCentr,Azam Campus 2390-B, K.B, Hidayatulla Rd, Camp, Pune, Maharashtra 411001
Pune
MAHARASHTRA 		 9764553222

dr.atharvachoudhary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committe 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: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  3d Printed Crown   These are Biocompatible Resin Materials, used along with a 3d printers in order to print customized crowns for pediatric patents. 
Intervention  Milled Zirconia Crown  These are Biocompatible zirconia milled crowns made from zirconia discs for pediatric patients. 
Comparator Agent  PREFORMED ZIRCONIA CROWN   NuSmile Texas USA 
Comparator Agent  Stainless Steel Cowns  3M ESPE USA 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1.Children reporting to the department of pediatric dentistry and belonging to the age group 4-9 years.
2.Children with no significant medical history.
3.Children indicated for receiving one or more preformed crowns on primary teeth- post-endodontic therapy, vital pulp therapy, multi surface caries restorations, patients with high caries risk, fractured teeth, teeth with extensive wear.
4.Teeth having adequate root support (more than 2/3rd of the root should be present).
5.Teeth with opposing natural teeth.
6.Children with definitely positive and positive behavior according to FRANKEL BEHAVIOUR RATING SCALE.
 
 
ExclusionCriteria 
Details  1.Parents of the child not willing to participate in the study.
2.Children with special health care needs.
3.Teeth having inadequate root support and excessive mobility.
4.Teeth with periapical pathology.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
There is some difference in the performance and acceptance of various types of crowns for primary teeth based on their clinical performance.  1 Week
3 Months
6 Months  
 
Secondary Outcome  
Outcome  TimePoints 
There is no difference in the performance and acceptance of various types of crowns for primary teeth based on their clinical performance.  1 Week
3 Months
6 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   N/A 
Date of First Enrollment (India)   04/11/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a prospective randomized parallel group study. 50 Teeth will be divided into five groups.

      Group A – Preformed Zirconia Crown

     Group B – Zirconia crowns milled following an intraoral scan

    Group C – 3D printed resin crowns printed following an intraoral scan

     Group D ­­­­­– Stainless Steel Crowns

CLINICAL PROCEDURE

 

Group A –Preformed Zirconia Crown

·         After clinical and radiographic examination of the chosen teeth, treatment will be provided using the following protocol:

·         Topical anaesthetic will be applied on the region where local anaesthesia is to be given.

·         Local anesthesia using Lidocaine Hydrochloride 2% will be administered, rubber dam isolation followed by crown size selection will be done considering the mesio-distal width of the tooth. Removal of caries/ indicated pulp therapy, and restoration of the remaining tooth structure will be done.

·         Buccal & lingual cusps will be reduced to the depth of central grooves, maintaining cuspal inclines with the tip of a football diamond bur.

·         A football diamond bur will be used to reduce central groove by approximately 0.5mm and to prepare the buccal and lingual occlusal third of clinical crown.

·         The tip of black stripe diamond bur will be used for depth cuts of 0.5mm on the Buccal and lingual surface and for the interproximal slices of about 1mm.

·         The depth cuts will be levelled and facial/lingual interproximal line angles will be rounded.

·         A shoulder margin will be created gingivally

·         A test fit will be done with a Try-in crown

·         The shoulder margin will be removed and the preparation will be extended subgingivally to feather-edge with a green stripe diamond bur.

·         Final test fitting will be done.

·         The selected teeth will be isolated with rubber dam the preformed crowns will be tried and cemented in place, resin modified glass ionomer cement can              be employed to place crown with light cure, followed by application of light finger pressure.

·         Clean up and flossing will be done after crown placement cementation.

·         A PVS impression for the opposing jaw will be taken.

 

Group B – Zirconia crowns milled after an intraoral scan

·         After clinical and radiographic examination of the chosen teeth, treatment will be provided using the following protocol:

·         Topical anaesthetic will be applied on the region where local anaesthesia is to be given.

·         Local anesthesia using Lidocaine Hydrochloride 2% will be administered, followed rubber dam isolation and removal of caries/indicated pulp therapy followed by restoration of the remaining tooth structure.

·         The mesial, distal, buccal, and lingual walls of the chosen teeth will be prepared 0.8-1.0 mm using a diamond bur with a round end taper so that a chamfer margin will be prepared circumferentially.

·          Each tooth’s occlusal surface will be reduced with a gap of 1.5 mm left with the opposing tooth using a round wheel diamond rotary instrument.

·         The prepared teeth will be digitally scanned with Dental Scanners, and the crowns will be designed as a full coronal restoration with the help of a software­­ to create STL files and to fabricates those crowns.

·         Crowns will be milled using Zirconia blanks with CAD/CAM system.

·         Crown trial will be done followed by evaluation of occlusion

·         The selected teeth will be isolated with rubber dam the milled crowns will be tried and cemented in place, resin modified glass ionomer cement can              be employed to place crown with light cure, followed by application of light finger pressure.

·         Clean up and flossing will be done after crown placement and cementation.

·         A PVS impression for the opposing jaw will be taken.

 

Group C – 3D printed resin crowns printed after an intraoral scan

 

·         After clinical and radiographic examination of the chosen teeth, treatment will be provided using the following protocol:

·         Topical anaesthetic will be applied on the region where local anaesthesia is to be given.

·         Local anesthesia using Lidocaine Hydrochloride 2% will be administered, rubber dam isolation followed by removal of caries/ indicated pulp therapy, and restoration of the remaining tooth structure.

·         The mesial, distal, buccal, and lingual walls of the chosen teeth will be prepared 0.8-1.0 mm using a diamond bur with a round end taper so that a chamfer margin will be prepared circumferentially. Each tooth’s occlusal surface will be reduced with a gap of 1.5 mm left with the opposing tooth using a round wheel diamond rotary instrument.

·         The prepared teeth will be digitally scanned with Dental Scanners, and the crowns will be designed as a full coronal restoration with the help of­­ a software to create STL files and to fabricates those crowns.

·         The crowns will be manufactured via a three-dimensional dental printer utilizing a 3D printable, biocompatible, ceramic filled resin.

·         Crown trial will be done followed by evaluation of occlusion.

·         The selected teeth will be isolated with rubber dam the printed crowns will be tried and cemented in place, resin modified glass ionomer cement can              be employed to place crown with light cure, followed by application of light finger pressure.

·         Clean up and flossing will be done after crown placement and cementation.

·         A PVS impression for the opposing jaw will be taken.

Group D – Stainless Steel crowns 

·         After clinical and radiographic examination of the selected teeth, treatment will be provided using the following protocol:

·         Topical anaesthetic will be applied on the region where local anaesthesia is to be given.

·         Local anesthesia using Lidocaine Hydrochloride 2% will be administered, followed rubber dam isolation and removal of caries/indicated pulp therapy followed by restoration of the remaining tooth structure.

·         The proximal surfaces will be reduced using a No. 69L bur.

·         Near-vertical reductions will be made on the proximal surfaces and carried gingivally until the contact with the adjacent tooth is broken.

·         The cusps and the occlusal portion of the tooth will then be reduced with a No. 69L bur.

·         The general contour of the occlusal surface is followed, and approximately 1 mm of clearance is kept with the opposing teeth.

·         The No. 69L bur at high speed will also be used to remove all sharp line and point angles.

·         The buccal bulge is reduced wherever necessary.

·         The smallest crown that completely covers the preparation will be chosen.

Isolation of the prepared tooth will be done before crown cementation.

Luting GIC will be prepared as per manufacturer’s instruction just prior to crown cementation.

The Stainless-Steel crown will then be filled with GIC and will be placed on the prepared crown with finger pressure.

Clean up and flossing will be done after crown placement and cementation.

A PVS impression for the opposing jaw will be taken.

 

FOLLOW UP

Follow up of the all restorations will be set at 1 week, 3 months, 6 months.

 
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