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CTRI Number  CTRI/2025/09/095078 [Registered on: 19/09/2025] Trial Registered Prospectively
Last Modified On: 18/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study on Gold and Rose Gold Crowns in Kids: Cleanliness, Comfort, and Parental Views 
Scientific Title of Study   Comparative Evaluation of Parental Satisfaction, Patient Acceptance and Clinical Success of Stainless Steel Crown and Titanium Coated Preformed Primary Crowns.  
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 K Maheshkumar 
Designation  Assitant Professor 
Affiliation  SRI SIDDHARTHA DENTAL COLLEGE 
Address  Room no: 6 Department of Pedodontics Sri Siddhartha Dental college and Hospital Tumkur,Karnataka,India.572107 Sri siddhartha academy of higher education.Tumkur.Karnataka.India.

Tumkur
KARNATAKA
572107
India 
Phone  7010950226  
Fax    
Email  kmaheshkumarbds@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Maheshkumar 
Designation  Assitant Professor 
Affiliation  SRI SIDDHARTHA DENTAL COLLEGE 
Address  Room no: 6 Department of Pedodontics Sri Siddhartha Dental college and Hospital Tumkur,Karnataka,India.572107 Sri siddhartha academy of higher education.Tumkur.Karnataka.India.

Tumkur
KARNATAKA
572107
India 
Phone  7010950226  
Fax    
Email  kmaheshkumarbds@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K Maheshkumar 
Designation  Assitant Professor 
Affiliation  SRI SIDDHARTHA DENTAL COLLEGE 
Address  Room no: 6 Department of Pedodontics Sri Siddhartha Dental college and Hospital Tumkur,Karnataka,India.572107 Sri siddhartha academy of higher education.Tumkur.Karnataka.India.
Room No:6 Department of Pedodontics Sri Siddhartha Dental College and Hospital Tumkur Karnataka India
Tumkur
KARNATAKA
572107
India 
Phone  7010950226  
Fax    
Email  kmaheshkumarbds@gmail.com  
 
Source of Monetary or Material Support  
Room no: 6 Department of Pedodontics Sri Siddhartha Dental college and Hospital Tumkur,Karnataka,India.572107 Sri siddhartha academy of higher education.Tumkur.Karnataka.India. 
 
Primary Sponsor  
Name  Dr K Maheshkumar 
Address  Room no: 6 Department of Pedodontics Sri Siddhartha Dental college and Hospital Tumkur,Karnataka,India.572107 Sri siddhartha academy of higher education.Tumkur.Karnataka.India. 
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 MAHESHKUMAR K  Sri Siddhartha Dental College and Hospital  Room no: 6 Department of Pedodontics Sri Siddhartha Dental college and Hospital Tumkur,Karnataka,India.572107 Sri siddhartha academy of higher education.Tumkur.Karnataka.India.
Tumkur
KARNATAKA 
7010950226

kmaheshkumarbds@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SIDDHARTHA DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICAL COMMITEE  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  Gold crown , Rose gold Esthetic crown  Evaluating the parental and children acceptence for gold and rose gold crown this study follow up will do up to 9 months Total duration: 12 months 
Comparator Agent  stainless steel crown   evaluating the parental and children acceptence for stainless steel crown this study follow up will do up to 9 months Total duration: 12 months 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Cooperative and healthy children between 4 and 9 years
2. Children underwent pulpectomy or pulpotomy-treated teeth with two-thirds of the root present.
3. Children without any more internal/external resorption
 
 
ExclusionCriteria 
Details  1. Teeth frankly infected either abscess, sinus tract or obvious inter radicular radiolucency.
2. Presence of any systemic disorders.
3. Special health care need children.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
child and parental acceptence an d and satisfaction  placemnt differnt type of esthetic crown
4 weeks - follow up
3 months - follow up
9 months -follow up
12 months -follow up 
 
Secondary Outcome  
Outcome  TimePoints 
clinical success of gold crown rose gold crown   placemnt differnt type of esthetic crown
4 weeks - follow up
3 months - follow up
9 months -follow up
12 months -follow up 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
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)   07/10/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 main global burden on oral health. Almost one-third of the world’s population, are affected by dental caries, one of the most common and ubiquitous pathological illnesses. Dental Caries in primary teeth can cause discomfort, affect speech and loss of confidence.1 Since primary teeth are necessary for chewing, speaking, and maintaining natural space in the dental arch, it is essential that they receive proper care.2

Selecting an appropriate restoration technique is a crucial step in achieving best treatment outcomes. The most common restoration material is glass ionomers, composite resin, compomer, amalgam, or prefabricated crowns.3

Preformed Stainless steel crowns/ zirconia crowns are the most commonly used treatment modality for extensive carious lesions.

The superiority and durability of stainless-steel crowns over multi-surface amalgam and other restorations in the primary dentition have made preformed SSC crown an invaluable restorative technique for the treatment of grossly decayed primary teeth.4 The major disadvantage of stainless steel crown was its aesthetics.

Zirconia crown which is introduced as a newer material as a result of technological advancements is highly acceptable to parents and children due to excellent esthetics, resistance to fracture, biocompatibility, reduced plaque accumulation, colour stability, and potentially less technique sensitivity.5 But due to extensive tooth reduction because of their inflexibility and thickness, it is time consuming and can cause discomfort to the children.

Titanium-nitride coated crown (TiNC) is a recently introduced full coverage crown with a titanium-nitride (TiN) coating on its surface,the titanium-nitride (TiN) coating makes the crown look yellow or gold in colour and also strengthens the hardness of the surface.6

Recently another titanium-nitride coated crown, Rose Gold crowns is being introduced, which looks more elegant and can be acceptable to the children.

There are no studies comparing the parental satisfaction, child acceptance and clinical durability between Stainless steel crowns, Gold crowns and Rose gold crowns.

Hence this study is conducted to comparative evaluation of parental satisfaction, patient acceptance and clinical success of stainless steel crown and titanium coated preformed primary crowns.

 

 
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