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CTRI Number  CTRI/2022/12/048617 [Registered on: 30/12/2022] Trial Registered Prospectively
Last Modified On: 09/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   clinical evaluation of 2 different types of crowns when placed with different techniques of crown placement 
Scientific Title of Study   Comparative evaluation of clinical and radiographic success after placement of preformed stainless steel and flexible esthetic crowns by various techniques in pediatric patients – A parallel group prospective randomized clinical study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amol Patil 
Designation  Associate Professor 
Affiliation  M A Rangoonwala College of Dental Sciences and Research Institute Pune  
Address  M A Rangoonwala College of Dental Sciences and Research Institute, Department of Pedodontics, room no 206, Camp, Pune Pune MAHARASHTRA 411001 India
M A Rangoonwala College of Dental Sciences and Research Institute, Department of Pedodontics, room no 206, Camp, Pune Pune MAHARASHTRA 411001 India
Pune
MAHARASHTRA
411001
India 
Phone    
Fax    
Email  amolpatil2526@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amol Patil 
Designation  Associate Professor 
Affiliation  M A Rangoonwala College of Dental Sciences and Research Institute Pune  
Address  M A Rangoonwala College of Dental Sciences and Research Institute, Department of Pedodontics, room no 206, Camp, Pune Pune MAHARASHTRA 411001 India
M A Rangoonwala College of Dental Sciences and Research Institute, Department of Pedodontics, room no 206, Camp, Pune Pune MAHARASHTRA 411001 India
Pune
MAHARASHTRA
411001
India 
Phone    
Fax    
Email  amolpatil2526@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amol Patil 
Designation  Associate Professor 
Affiliation  M A Rangoonwala College of Dental Sciences and Research Institute Pune  
Address  M A Rangoonwala College of Dental Sciences and Research Institute, Department of Pedodontics, room no 206, Camp, Pune Pune MAHARASHTRA 411001 India
M A Rangoonwala College of Dental Sciences and Research Institute, Department of Pedodontics, room no 206, Camp, Pune Pune MAHARASHTRA 411001 India
Pune
MAHARASHTRA
411001
India 
Phone    
Fax    
Email  amolpatil2526@gmail.com  
 
Source of Monetary or Material Support  
M A Rangoonwala College of Dental Sciences Department of Pedodontics Room no 406 Azam Campus Pune - 411001  
 
Primary Sponsor  
Name  Dr Amol Patil 
Address  M A Rangoonwala College of Dental Sciences and Research Institute, Department of Pedodontics, room no 206, Camp, Pune Pune MAHARASHTRA 411001 India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
none  none 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amol Patil  M A Rangoonwala College of Dental Sciences and Research Institute  Department of Pedodontics Room no 406 Azam Campus Hidaytulla road CAMP Pune 411001
Pune
MAHARASHTRA 
9561042279

amolpatil2526@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of M.C.E. Society, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conventional technique of tooth preparation  Bioflex and stainless steel Crowns will be placed with conventional techniques of tooth preparation duration is 12 months 
Comparator Agent  Different techniques of tooth preparation like halls and modified halls  Bioflex and stainless steel crowns will be placed by different techniques of tooth preparation duration is 12 months 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Patients and parents of the patients who accept to participate and sign the informed consent
Primary teeth indicated for full coverage restoration.
Frankel’s positive and definitely positive patients
Children aged between 4 to 10 years.
No significant medical history.
Patients willing to return for follow-up examinations and evaluation.
No active periodontal diseases.
 
 
ExclusionCriteria 
Details  Patients and parents of the patients who do not accept to participate and sign the informed consent
Patients with a systemic disease,
Teeth which have a short period of time for succedaneous teeth to erupt
Any subject that does not fall under the inclusion criteria were excluded
Children with special needs.
Presence of malocclusion like cross bite, crowding, scissor bite etc.
Lived in remote villages and were unlikely to return for follow-up
Patients with TMJ abnormalities.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is the success of the treatment. Success
will be defined by the absence of major failure
fracture, wear, color change
Duration, occlusion, gingival margin extension and parent
acceptance will be clinically evaluated at baseline and at last
appointment

 
12 months 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes are parental and child satisfaction (size, form, and function), retention and fracture of the crown.
. Finally, the wear of the antagonist tooth will be recorded (0: absence of wear; 1: wear on only the cusp point; and 2: wear at least at the cusps) reference. To prevent information bias, the evaluators will not be the operators who applied the treatment.
 
12 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/01/2023 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
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 - 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 [amolpatil2526@gmail.com].

  6. For how long will this data be available start date provided 14-12-2022 and end date provided 14-12-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary
Modification(s)  

Dental caries is an infectious transmittable bacterial disease, which is characterized by a multi-factorial pathology.1 In the early childhood the caries (ECC) have effects on both dental and general health of the child.2 Oral health impacts on the quality of life of children 3, 4. However, extreme caries have a noticeable impact on the diameter of the arch.5

        In order to preserve the functional integrity of primary dentition, it is important to perform different restorative treatment due to an increase in the prevalence of dental caries today.6 In all restorative procedures, there is a loss of some amount of tooth structure, these damaged teeth can be restored with various restorative materials such as resin modified glass ionomer cement, resin filled composite or resin filled composite.7 For primary molar teeth, preformed metal crown were first described by Engle8 in year 1950 and followed by Humphrey.9 Since then, crown design modifications are done, to improve morphology of crown and to simplify the fitting procedure.10 Stainless steel crowns are the first choice for restoring defects due to caries in primary dentition and the most reliable and successful form of tooth restoration is in pediatric dentistry.9 Stainless steel crown placement is easy and economical with a high success rate for preserving remaining teeth damaged by excessive preparation.11,12 Esthetic concern is reported to be the most important problem for dental restoration in a study in pediatric patients.13Accordingly, new materials have been created to replace SSCs, such as bonded strip crowns, open-faced crowns and pre-veneered SSCs.14,15 These new materials have enhanced aesthetics but have side effects such as poor gingival health and dental margin exposure due to metal presence.11 In particular pre-veneered SSC veneer resin sometimes chips and results in additional care..15,16

            Today, for the restoration of the primary teeth, the dental practitioner has various options like preformed zirconia crowns for esthetic concern. Based on technical, functional and esthetic limitations, each technique is associated with the own sets of advantages and disadvantages.17, 18, 19

    Alternative to these, prefabricated esthetic flexible crowns are comparatively new. Flexible crowns allow practitioner to provide aesthetics of new age crowns and easy, economical as well as conservative preparation of stainless steel crowns in addition to that  they can be corrected like SSCs and that’s the reason this study is planned

 

In recent years restoring carious or fractured primary teeth with stainless steel crowns (SSC) has became more popular than ever. On the other hand the traditional operative approach of complete removal of caries is steadily losing support due to successful results with materials of high microleakage resistance.

Treatment time and pain control in asymptomatic teeth has always been a problem in children. Hall technique is a minimally invasive treatment protocol that doesn’t require local anesthesia, use of rotating devices for caries removal to restore primary teeth with SSC.

But this protocol also raised questions in the scientific community about its possible effects on the dentition and temporomandibular joint (TMJ) for causing primary occlusal contact and increasing vertical dimension.

 

Preformed metal crowns (PMCs) have high success rates in restoring primary molars in children but they were not generally used by dentists, especially in developing countries due to its demand of high clinical skills with the conventional technique (CT). The biological approach, Hall technique (HT), requires less training and can be placed by less experienced dental operators including therapists. Previous studies were mainly carried out in developed countries. The aims were to investigate and compare the efficacies and cost-effectiveness of preformed stainless steel and flexible esthetic crowns

 

The purpose of this study is to compare the effectiveness of the flexible esthetic crown to the conventional Stainless-Steel Crown restoration by various techniques in the treatment of primary molars with dentinal caries with or without proximal ridge intact.

 

 
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