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CTRI Number  CTRI/2025/04/084114 [Registered on: 04/04/2025] Trial Registered Prospectively
Last Modified On: 02/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study comparing two diiferent crowns for milk tooth 
Scientific Title of Study   Clinical performance of preformed CAD CAM milled PMMA crown and stainless steel crown for primary molar teeth using dental operating microscope 
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 A K Shanmugaavel  
Designation  Reader 
Affiliation  Chettinad Dental College and Research Institute  
Address  Room no 6, 3rd floor, E block, Chettinad Dental College and Research Institute, Kelambakkam, Chennai.

Kancheepuram
TAMIL NADU
603103
India 
Phone  8838603094  
Fax    
Email  shanpedodontist@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A K Shanmugaavel  
Designation  Reader 
Affiliation  Chettinad Dental College and Research Institute  
Address  Room no 6, 3rd floor, E block, Chettinad Dental College and Research Institute, Kelambakkam, Chennai.

Kancheepuram
TAMIL NADU
603103
India 
Phone  8838603094  
Fax    
Email  shanpedodontist@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr A K Shanmugaavel  
Designation  Reader 
Affiliation  Chettinad Dental College and Research Institute  
Address  Room no 6, 3rd floor, E block, Chettinad Dental College and Research Institute, Kelambakkam, Chennai.

Kancheepuram
TAMIL NADU
603103
India 
Phone  8838603094  
Fax    
Email  shanpedodontist@gmail.com  
 
Source of Monetary or Material Support  
Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai 603013. 
 
Primary Sponsor  
Name  Dr A K Shanmugaavel  
Address  Room no 6, 3rd floor, E block, Chettinad Dental College and Research Institute, Kelambakkam, Chennai. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 A K Shanmugaavel  Chettinad Dental College and Research Institute   Room no 6, 3rd floor, E block, Chettinad Dental College and Research Institute, Kelambakkam, Chennai.
Kancheepuram
TAMIL NADU 		 8838603094

shanpedodontist@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee - Chettinad Dental College and Research InstituteĀ   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Preformed milled pmma crowns   Preformed milled PMMA crowns are given for the multi surface caries in primary teeth and followed up for the clinical effeciency at baseline 1 week 3rd and 6th month  
Comparator Agent  Stainless Steel Crowns  Stainless Steel Crowns are given for the multi surface caries in primary teeth and follwed up for the clinical effeciency at baseline 1 week 3rd and 6th month 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children aged 4 to 10 years
Children requiring crown for the maxillary/ mandibular second primary molar.
Children with teeth expected to remain in place for over 2 years before exfoliation
Children with teeth that are pulpally treated
Children with caries affecting multiple surfaces, and stable occlusion. 
 
ExclusionCriteria 
Details  Children with
1. Disabilities and systemic diseases,
2. Frankl behavior classification scale rating of negative or definitely negative,
3. TMJ disorders
4. Oral habits such as bruxism. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical success rate   assessment of
1. survival rate
2. clinical signs of pathology including swelling and pain
3. Gum health in terms of gingival index are all assessed at baseline, 1 week , 3 months and 6 months interval  
 
Secondary Outcome  
Outcome  TimePoints 
Measurement of occlusal wear   Measurement of occlusal wear is done using intra oral scanner at baseline, 1 week , 3 months and 6 months interval  
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   24/04/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 29/04/2025 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [priyabalu1907@gmail.com].

  6. For how long will this data be available start date provided 17-02-2025 and end date provided 17-02-2030?
    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  

The proposed study will investigate the clinical performance and gingival health of preformed CAD/CAM milled polymethyl methacrylate (PMMA) crowns in comparison to stainless steel crowns (SSCs) for the restoration of primary molars with extensive multi-surface carious lesions. Given the growing emphasis on aesthetics in pediatric dentistry, SSCs, despite their long-standing use, face criticism due to their metallic appearance. Therefore, this randomized clinical trial aims to explore the viability of PMMA crowns as an aesthetic alternative while evaluating their clinical success and impact on gingival health.

The study will be conducted in a hospital-based setting, with primary molars undergoing pulpal treatment before restoration with either SSCs or PMMA crowns. Clinical and radiographic assessments will be performed at multiple follow-up intervals to evaluate parameters such as gingival health, plaque accumulation, crown retention, and potential complications. A non-parametric statistical approach will be utilized to analyze the collected data.

The expected outcome of this study is to provide insights into the potential advantages and limitations of PMMA crowns in comparison to SSCs, particularly in terms of aesthetics, clinical longevity, and biocompatibility. If found to be clinically effective and safe, PMMA crowns could serve as a promising aesthetic alternative to traditional SSCs for pediatric dental rehabilitation.

 
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