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CTRI Number  CTRI/2024/12/077528 [Registered on: 02/12/2024] Trial Registered Prospectively
Last Modified On: 01/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trail to study the clinical and radiographic success of stainless steel crowns and titanium nitride coated stainless steel crowns in primary molars 
Scientific Title of Study   Comparative evaluation of clinical and radiographic success of titanium nitride coated stainless steel crowns and stainless steel crowns in primary molars: A Randomized Controlled Study 
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 Ramya T R 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Research Institute, Bangalore 
Address  Department of Pedodontics, Government Dental College and Research Institute, Victoria Hospital Campus K. R. Market, Bangalore - 560002

Bangalore
KARNATAKA
560002
India 
Phone  8317344167  
Fax    
Email  ramyatreddy1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S K Srinath 
Designation  Head of the Department and Professor 
Affiliation  Government Dental College and Research Institute, Bangalore 
Address  Department of Pedodontics, Government Dental College and Research Institute, Victoria Hospital Campus K. R. Market, Bangalore - 560002

Bangalore
KARNATAKA
560002
India 
Phone  9845592166  
Fax    
Email  srinath.krishnappa@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr S K Srinath 
Designation  Head of the Department and Professor 
Affiliation  Government Dental College and Research Institute, Bangalore 
Address  Department of Pedodontics, Government Dental College and Research Institute, Victoria Hospital Campus K. R. Market, Bangalore - 560002

Bangalore
KARNATAKA
560002
India 
Phone  9845592166  
Fax    
Email  srinath.krishnappa@yahoo.com  
 
Source of Monetary or Material Support  
Government Dental College and Research Institute Bangalore, Victoria campus, India Pincode-560002 
 
Primary Sponsor  
Name  Dr Ramya T R 
Address  Department of Pedodontics Government Dental College and Research Institute Victoria Campus Fort Bangalore - 560002 
Type of Sponsor  Other [NIL] 
 
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 Ramya T R  Government Dental College and Research Institute  Room no 5, Department of Pedodontics, Government Dental College and Research Institute Victoria Campus Fort Bangalore - 560002
Bangalore
KARNATAKA 		 8317344167

ramyatreddy1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Government Dental College and Research Institute Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Stainless Steel Crown   Placement of Stainless Steel Crown  
Comparator Agent  Titanium Nitride coated stainless steel Crown  Placement of Titanium Nitride coated Stainless Steel Crown  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Healthy Co-operative child patients aged 6-9 years with primary mandibular molars treated with pulp therapy
(Pulpotomy and Pulpectomy) or with multi-surface carious lesions. 
 
ExclusionCriteria 
Details  Tooth with internal resorption, tooth with more than 2/3 root resorption, Patients with very poor oral hygiene and DMFT score more than 5, Patients with known allergy to nickel and titanium, Patients with bruxism habit. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage of clinical and radiographic success of Titanium nitride coated stainless
Steel crowns and stainless steel crowns at the end of on year  		 1 3 6 and 12 months  
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of success of gingival health and plaque accumulation of Titanium
Nitride coated stainless steel crowns and stainless steel crowns at the end of one year. 		 1 3 6 and 12 months 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   20/12/2024 
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="1"
Months="6"
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   Dental caries is one of the widespread medical conditions in adults and children. According to WHO Oral Health facts, more than 530 million children suffer from dental caries of primary teeth. The management of multi-surface carious primary molar is challenging to clinician, there are variety of materials such as amalgam, composites, and stainless steel crowns (SSC’s) used to reconstruct the carious teeth. SSC’s are widely used and are very popular in pediatric dentistry due to its superiority and durability compared to multi surface amalgam restorations. However, the disadvantage is poor esthetics and perforation rate of approximately 2%. Titanium nitride coated stainless steel crowns (TiNC’s) is newly introduced, which have golden colour and its hardness have been proposed to be better than that of conventional SSC’s. It is also esthetically more appreciated by parents. Titanium is widely used in Medical and Dentistry, with high success rates, due to its high corrosion resistance, low toxicity, very low allergic potential and biocompatibility. The introduction of TiNCs has broadened the range of options for posterior teeth restoration.1 Titanium nitride coating makes the crown appear yellow/golden color, it tends to attract children’s attention and seemed to be more likeable. However no long-term studies are available regarding TiNCs. It is important to assess gingival health, oral hygiene status of the teeth restored with SSC’s and TiNC’s. Keeping in mind the paucity of literature, this study is designed to explore the clinical and radiographic success, gingival health and plaque accumulation of TiNC’s against SSC’s in primary molars. 
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