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CTRI Number  CTRI/2025/02/080027 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparison of gum health and clinical success of stainless steel crown, zirconia and edelweiss crowns in milk teeth : A randomised clinical trial  
Scientific Title of Study   A comparative evaluation of periodontal health and clinical success of prefabricated stainless steel crown, zirconia and edelweiss crowns in primary molars : A randomised clinical 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. Rajeev kumar singh 
Designation  Professor  
Affiliation  King Georges Medical University 
Address  New dental building kgmu shah mina road chowk lucknow uttar pradesh

Lucknow
UTTAR PRADESH
226003
India 
Phone  9450849528  
Fax    
Email  rajkids2000@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mayank Goel 
Designation  Junior Resident  
Affiliation  King Georges Medical University 
Address  New Dental Building FODS KGMU Shah Mina road Chowk Lucknow 226003

Lucknow
UTTAR PRADESH
226003
India 
Phone  8948406288  
Fax    
Email  goelmayank781@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajeev Kumar Singh 
Designation  Professor  
Affiliation  King Georges Medical University 
Address  New Dental Building KGMU Shah Mina road Chowk Lucknow 226003

Lucknow
UTTAR PRADESH
226003
India 
Phone  9450849528  
Fax    
Email  rajkids2000@yahoo.co.in  
 
Source of Monetary or Material Support  
KING GEORGES MEDICAL UNIVERSITY, Lucknow Uttar Pradesh India 226003 
 
Primary Sponsor  
Name  Dr Rajeev Kumar Singh 
Address  FODS, Department of paediatric and preventive dentistry KGMU Lucknow Uttar pradesh - 226003 
Type of Sponsor  Other [Other [self funded]] 
 
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 Rajeev kumar singh  Faculty Of Dental Sciences  4th floor, New Dental Building, Department of paediatric and preventive dentistry, Faculty Of Dental Sciences, King Georges Medical University,Chowk, Lucknow Uttar Pradesh -226003
Lucknow
UTTAR PRADESH 
9450849528

rajkids2000@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King Georges Medical University Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K085||Unsatisfactory restoration of tooth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Edelweiss Crown  After completion of pulpectomy in primary molar teeth edelweiss crown will be placed according to manufacturer instructions. Follow up of 1 year will be taken. 
Comparator Agent  Stainless steel crown  After completion of pulpectomy in primary molar tooth stainless steel crown will be placed according to manufacturer instructions. follow up of 1 year will be taken 
Intervention  Zirconia Crown  After completion of pulpectomy in primary molar tooth zirconia crown will be placed according to manufacturer instructions.Follow up of will be taken for 1 year 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1.Children aged 4 to 9 years, indicated for pulpectomy followed by full coverage restoration.
2.Healthy cooperative children free of any systemic ailment or any developmental disturbances of the teeth and jaws that would affect patient’s diet, caries susceptibility or the selection of restorative material.
3.Presence of antagonist tooth, willingness to participate in the study and to continue with the follow-up appointments.
4.Teeth with more than two-third of the root length.
 
 
ExclusionCriteria 
Details  1.Teeth with internal resorption
2.Teeth with physiologic root resorption more than one-third of the root length
3.Teeth that are non-restorable
4.Patients with compromised general health due to systemic disease
5.Excessive hemorrhage encountered during the clinical procedure
6.Exposures with purulent discharge or serous exudate 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Clinical success assessment criteria for each crown as retention.
2.periodontal health assessment 
At baseline (T0)
At one month (T1)
At three month (T2)
At six month (T3)
At twelve month (T4) 
 
Secondary Outcome  
Outcome  TimePoints 
Parental Satisfaction  At baseline (T0)
At one month (T1)
At three month (T2)
At six month (T3)
At twelve month (T4) 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   20/02/2025 
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="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  

For children’s overall development, maintaining a healthy primary dentition is crucial. Three crucial factors are preservation of tooth structure, restorative durability, and parental satisfaction. In paediatric dentistry, several methods for full-coverage restorations have been developed.Aim is to evaluate and compare the clinical success and periodontal health of children after restoring primary molars with stainless steel crown or zirconia crown or edelweiss pediatric crown (edelweiss dentistry ®) using plaque index(PI) and gingival index(GI) and simplified oral health index(OHI -S) at one,three,six &twelve month interval.The present study is a randomised controlled clinical trial which will be conducted in the Department of Paediatric and Preventive Dentistry, Faculty of Dental Sciences, King George’s Medical University in Lucknow, Uttar Pradesh.. All patients will be selected after obtaining detailed history and thorough clinical examination. All children had at least one decayed primary molar teeth requiring full coverage restoration and an antagonist tooth and met the remaining inclusion criteria: willingness to participate in the study and to continue with the follow-up appointments.Before beginning their treatments, children, along with their parents, received a standard oral hygiene education, which consisted of a brushing demonstration by a postgraduate dental student on a model only once.Throughout the follow-ups, parents were warned when signs of gingival inflammation were present or plaque control was inadequate.The data for each tooth will be recorded on individual data record sheet. The final data will be transferred to master data sheet. The data thus obtained will be subjected to statistical analysis


 
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