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CTRI Number  CTRI/2022/06/043411 [Registered on: 22/06/2022] Trial Registered Prospectively
Last Modified On: 22/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two techniques of minimally invasive method of stainless steel crown in children.  
Scientific Title of Study   Clinical evaluation of preformed stainless-steel crowns placed with modified versus standard hall technique in management of occluso-proximal dentinal caries in primary molars. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rini C 
Designation  PG student 
Affiliation  SGT university 
Address  Room no.6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurgaon.

Gurgaon
HARYANA
122505
India 
Phone  9953249879  
Fax    
Email  dr.rinichacko@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shalini Garg 
Designation  Professor 
Affiliation  SGT University 
Address  Room no.6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurgaon

Gurgaon
HARYANA
122505
India 
Phone  9215668621  
Fax    
Email  shalini_fdsc@sgtuniversity.org  
 
Details of Contact Person
Public Query
 
Name  Rini C 
Designation  PG Student 
Affiliation  SGT university 
Address  Room no.6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurgaon

Gurgaon
HARYANA
122505
India 
Phone  9953249879  
Fax    
Email  dr.rinichacko@gmail.com  
 
Source of Monetary or Material Support  
not applicable 
 
Primary Sponsor  
Name  SGT University 
Address  Faculty of Dental Science, SGT University, Gurugram-122505 
Type of Sponsor  Research institution and hospital 
 
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 
Rini C  SGT University  Room no.6, Department of Pediatric and Preventive Dentistry, Faculty of Dental sciences, Chandu Budhera, Gurugram
Gurgaon
HARYANA 
9953249879

dr.rinichacko@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI GURUGOBIND SINGH TRICENTENARY UNIVERSITY, GURGAON  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dental Caries 
Patients  , (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Clinical evaluation of preformed stainless-steel crowns placed with modified versus standard hall technique in management of occluso-proximal dentinal caries in primary molars.  Comparative assessment of occlusion by modified (with proximal slicing) versus standard hall technique (non-invasive) and to assess child’s intraoperative behaviour, chair time and clinical success after placement of preformed stainless-steel crown with occluso-proximally carious primary molars over a period of 03 months. 
Comparator Agent  nil  nil 
Intervention  Randomized Clinical trial  Comparative assessment of occlusion by modified (with proximal slicing) versus standard hall technique (non-invasive) and to assess child’s intraoperative behaviour, chair time and clinical success after placement of preformed stainless-steel crown with occluso-proximally carious primary molars over a period of 03 months. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. A case of Occluso-proximal dentinal caries in primary molar
2. The lesion ICDAS should not be less than 4 and more than 5.
3. Radiographic examination should not show caries involvement more than half of dentinal shadow.
4. The occlusal surface should not be involved more than half of total dimension (occlusal table).
 
 
ExclusionCriteria 
Details  1. Sign and Symptoms of irreversible pulpitis.
2. Peri apical/ inter radicular Radiographic changes due to caries.
3. Patient with severe occlusal discrepancies.
4. Pre-treated, restorative treatment done on the tooth.
 
 
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 
Clinical evaluation of preformed stainless-steel crowns placed with modified versus standard hall technique in management of occluso-proximal dentinal caries in primary molars.  Clinical evaluation immediately, at1 week,1month,2month, 3month, and 6month for all the cases. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate clinical success and effectiveness on occurrence of new caries.  Clinical evaluation and patient acceptance at 6months and 12months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/06/2022 
Date of Study Completion (India) 21/06/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 21/06/2023 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The hall technique is minimally invasive type of caries management technique for treating occluso-proximal carious primary molars. The hall technique has biological principle as it can arrest caries and protect the tooth until it sheds. The essential layer in the biofilm responsible for caries progression (superficial plaque layer), is left and sealed along with the caries. As a response the composition of the plaque biofilm will be altered to a less cariogenic flora.  Using hall technique, the crown is cemented without local anaesthesia, caries removal or tooth preparation. As occlusal reduction is not done in standard hall technique, there will be discrepancy in the occlusion and occlusal vertical dimension. In modified hall technique the occlusion might settle faster as compared to standard halls technique due to minimal occlusal reduction done prior to the placement of Preformed Stainless Steel Crown (PMC). In intraoperative stage, patient acceptance regarding pain and anxiety can be recorded using self-reported Wong Baker Faces Pain Rating Scale. Children have to select from six faces which represent closely to how they felt at the time of assessment and Frankl scores can also be evaluated. This study aims to assess the occlusion after placement of preformed stainless-steel crown in occluso–proximally carious primary molars by modified versus standard hall technique over period of  12months and also to assess the child’s intraoperative behaviour acceptance after placement of preformed stainless-steel crown.


 
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