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CTRI Number  CTRI/2025/09/095227 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study on digital crowns treated with either chemical or sand particles for the evaluation of the dislodgement, chipping-off, fractures on the milk tooth of children. 
Scientific Title of Study   Evaluation of the Clinical Performance of 3D Printed Resin Crowns modified by Mechanical and Chemical Surface Treatments of Intaglio Surface - A Split Mouth Randomised Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Smritti Jaiswal 
Designation  First Year Postgraduate  
Affiliation  Vishnu Dental College 
Address  Department of Pedodontics and Preventive Dentistry, Second Floor, Block - III, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh - 534202

West Godavari
ANDHRA PRADESH
534202
India 
Phone  7981601118  
Fax    
Email  smritti.j@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Penmatsa Chaitanya 
Designation  Professor 
Affiliation  Vishnu Dental College 
Address  Department of Pedodontics and Preventive Dentistry, Second Floor, Block - III, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh - 534202

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9908217142  
Fax    
Email  drchaitanyamds@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Penmatsa Chaitanya 
Designation  Professor 
Affiliation  Vishnu Dental College 
Address  Department of Pedodontics and Preventive Dentistry, Second Floor, Block - III, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh - 534202

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9908217142  
Fax    
Email  drchaitanyamds@gmail.com  
 
Source of Monetary or Material Support  
Vishnu Dental College,Vishnupur,Bhimavaram - 534202 
 
Primary Sponsor  
Name  Dr Smritti Jaiswal 
Address  Department of Pedodontics and Preventive Dentistry, Second Floor, Block - III, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh - 534202 
Type of Sponsor  Other [Self] 
 
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 Smritti Jaiswal  Vishnu Dental College  Department of Pedodontics and Preventive Dentistry, Second Floor, Block - III, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh - 534202
West Godavari
ANDHRA PRADESH 
7981601118

smritti.j@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, VISHNU DENTAL COLLEGE BHIMAVARAM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  3D Printed resin crowns  3D Printed resin crowns on pulpectomised deciduous second molars 
Comparator Agent  Surface Treatment of the Intaglio surfaces of the 3D printed resin crowns  Sandblasting versus Hydrofluoric Acid comparision 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1) Children of age 4 - 9 years.
2) Children with bilateral pulp therapy treated primary second molars.
3) Healthy and co-operative children.
4) Patients who are willing to be part of this study 
 
ExclusionCriteria 
Details  1) Medically compromised children.
2) Children with para-functional habits.
3) Pulpectomy treated teeth with decay extending beneath the free gingival margin.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical performance of the crowns underwent two different surface treatments using USPHS criteria  03,06,09,12 months 
 
Secondary Outcome  
Outcome  TimePoints 
NILL  NILL 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   06/10/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

In this study, children of age 04 - 09 yrs who underwent bilateral pulp therapy treated primary second molars who are healthy and co-operative and are willing to be part are been included in the study,children who are medically compromised children and are with para-functional habits. And pulpectomy treated teeth with decay extending beneath the free gingival margin are been excluded from the study.

Children coming to outpatient block in Department of Pedodontics & Preventive Dentistry will be screened. Based on inclusion and exclusion criteria, 20 children will be recruited into study who underwent pulp therapy of the right and left milk tooth of the upper or lower back tooth region with the help of Computer-generated sequence, the children will be allocated into 2 groups using split mouth design.  After doing the tooth preparation  scanning using intraoral scanner then by the CAD-CAM software crowns are designed and printed with 3D printers and  prior to the cementation of the these 3d printed resin crowns the surface treatment of intaglio surfaces  will be done in one group mechanical surface treatment with sandblasting and in another group chemical surface treatment with hydrofluoric acid is done and are cemented to the tooth and their Clinical performance are assessed at using  U.S.P.H.S criteria at duration of 3,6,9,12 months.

 

 


 
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