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CTRI Number  CTRI/2024/12/077653 [Registered on: 04/12/2024] Trial Registered Prospectively
Last Modified On: 27/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of different crowns in teeth. 
Scientific Title of Study   Comparative evaluation of child-parental satisfaction and radiographic analysis of Bioflex, Zirconia and Stainless steel crowns in pediatric patients.  
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 Namrata Ingavale 
Designation  Post Graduate Student 
Affiliation  Government Dental College, Raipur. 
Address  Department of Pediatric and Preventive Dentistry , Room No. 11 , Government Dental College , Raipur.

Raipur
CHHATTISGARH
492001
India 
Phone  9743227618  
Fax    
Email  namratani8399@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sunil Pandey 
Designation  Associate Professor 
Affiliation  Government Dental College, Raipur. 
Address  Department of Pediatric and Preventive dentistry, Room No. 11 , Government Dental College, Raipur.

Raipur
CHHATTISGARH
492001
India 
Phone  9993912218  
Fax    
Email  drsunilpandeymds@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Namrata Ingavale 
Designation  Post Graduate Student 
Affiliation  Government Dental College, Raipur. 
Address  Department of Pediatric and preventive Dentistry , Room No. 11 , Government Dental College , Raipur.

Raipur
CHHATTISGARH
492001
India 
Phone  9743227618  
Fax    
Email  namratani8399@gmail.com  
 
Source of Monetary or Material Support  
Namrata Ingavale, Post graduate Student , Department of Pediatric and Preventive Dentistry , Government Dental College Raipur, Chhattisgarh , India , Pin NO. - 492001  
 
Primary Sponsor  
Name  Dr Namrata Ingavale 
Address  Department of Pediatric and Preventive Dentistry, Government Dental College, Raipur (C.G.) Pin NO. 492001 
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 Namrata Ingavale  Government Dental College  Department of Pediatric and Preventive Dentistry , Government Dental College, Rajbandha , Maidan Path, Near Marhi Mata Mandir , Raipur
Raipur
CHHATTISGARH 
9743227618

namratani8399@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human Studies)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Teeth with irreversible pulpitis requiring crown prosthesis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bioflex Crowns, Zirconia Crowns   Prosthesis after pulpectomy and/or Pulpotomy 
Comparator Agent  Stainless Steel Crowns  Prosthesis after pulpectomy and/or Pulpotomy 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.Patients within the age group of 5-10 years.
2.Healthy children free of any systemic disease.
3.Deciduous teeth having two-thirds of root structure left radiographically.
4.Presence of one-third of crown shape.
5.Children free of any developmental disturbances of the teeth.
6.Asymptomatic primary molars following pulp therapy indicated for full coverage restoration.
7.Patients with good oral hygiene.
8.Children with signed consent form by the parent or guardian after being informed about the various benefits, risks and treatment outcomes.
 
 
ExclusionCriteria 
Details  1.Teeth exhibiting Pre-shedding mobility.
2.Children with parafunctional habits.
3.A pathological discrepancy of root resorption.
4.Inflammation at the furcation area.
5.Deciduous teeth having not sufficient crown structure.
6.Teeth with root caries.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will help us to know which crown among the Bioflex , Zirconia and Stainless steel is better in terms of Clinical(GI & PI) , Radiographic (marginal adaptation) and child-parental satisfaction(MCDAS & likert scale).  12 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Best effective crown material among Bioflex , Zirconia and Stainless Steel is been evaluated , which will be helpful in future restorative treatments in Pediatric patients.  12 Months 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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   Phase 4 
Date of First Enrollment (India)   30/12/2024 
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)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    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 [namratani8399@gmail.com].

  6. For how long will this data be available start date provided 25-12-2025 and end date provided 25-12-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

54  samples will be collected and divided into Three groups each of n=18 namely :-

1. Group 1 – Patients with Bioflex Crowns as restoration.

2. Group 2 - Patients with Zirconia Crowns as restoration.

3. Group 3 - Patients with Stainless Steel Crowns as restoration.

                   54 Patients will be selected based on the Inclusion and Exclusion Criteria. Complete process of what process will going to perform on the tooth of the child will be explained to the Parents/The person accompanying the patient. All the procedures will going to be performed under rubber dam isolation. The Radiovisiography(RVG) radiographs will be taken. The crown to be prepared and patients will be divided into selected groups. The placement of Bioflex, Zirconia and Stainless Steel Crowns will be done. All the crowns will be placed by a single operator.

                  Local anesthesia will be administered and rubber dam will be placed. The manufacturer’s guidelines will be followed to develop a step by step customized tooth preparation to ensure all crowns were fitted in a similar manner. All crowns will be luted using type I Glass Ionomer Cement. The type and size of crown chosen as well any adaption methods done for each molar were recorded. Patients will be given postoperative instructions. Participants will recalled for follow up at 3 months, 6 months, 12 months. Variables for the clinicians satisfaction will be scored using a customized scoring table which was modified from similar previous studies.

                  Immediate post cementation radiograph will be taken for baseline measurements. Patient will then be recalled after 3, 6 and 12 months. The recalled patients will be checked for “plaque accumulation and gingival health” by using Plaque Index and Gingival Index, respectively. And the “Marginal Adaptation” will be checked by using Radiovisiography(RVG).

                    Child satisfaction is determined using Modified Child Dental Anxiety Scale(MCDAS). Parental satisfaction was assessed on a Likert type scale from 1 to 5. The questionnaire will be given to parents. Parents will asked to return the questionnaire on completion. Scores 1 and 2 were combined as satisfied, score 3 as neutral response and scores 4 and 5 were combined as dissatisfied. Scoring of parental and child satisfaction will be taken at 3 months, 6 months, 12 months .Then the respective outcomes will be compared.

 
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