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CTRI Number  CTRI/2025/04/085383 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On: 23/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to compare Hall techniue and traditional technique for stainless steel crown placement in childrens teeth and their effects on comfort and treatment outcome 
Scientific Title of Study   Comparative evaluation of clinical, radiographic and patient-centered outcomes of hall technique versus Conventional methods for stainless steel crown placement in pediatric dental patients: A randomized controlled study  
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 Gunjan Barot 
Designation  Post Graduate Student 
Affiliation  Karnavati School of Dentistry 
Address  A-907 Adalaj Uvarsad Road Gandhinagar

Gandhinagar
GUJARAT
382422
India 
Phone  6359319898  
Fax    
Email  barotgunjan98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chhaya Patel 
Designation  Professor 
Affiliation  Karnavati School of Dentistry 
Address  A-907 Adalaj Uvarsad Road Gandhinagar

Gandhinagar
GUJARAT
382422
India 
Phone  9638215549  
Fax    
Email  dr.chhayachildcare@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chhaya Patel 
Designation  Professor 
Affiliation  Karnavati School of Dentistry 
Address  A-907 Adalaj Uvarsad Road Gandhinagar

Gandhinagar
GUJARAT
382422
India 
Phone  9638215549  
Fax    
Email  dr.chhayachildcare@gmail.com  
 
Source of Monetary or Material Support  
Karnavati School of Dentistry A-907 Uvarsad-Adalaj Road Gandhinagar 382422  
 
Primary Sponsor  
Name  Dr. Gunjan Barot 
Address  51/D Pavitranagar Society Opposite Cadila Laboratory Ghodasar Ahmedabad 380050 
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 Gunjan Barot  Karnavati School of Dentistry  A-907, Karnavati University, Department of Pediatric and Peventive Dentistry, Adalaj Uvarsad Road 382422
Gandhinagar
GUJARAT 
6359319898

barotgunjan98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kanavati School of Dentistry Ethics Commitee (KSDEC)  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 
Comparator Agent  Stainless Steel Crown With Conventional Method  Placement of Stainless Steel Crown after tooth preparation- the conventional method. Duration:6 Months 
Intervention  Stainless Steel Crown with Hall Technique  Placement of stainless steel crown as a full coronal restoration with Hall Technique Durtion:6 Months 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1) 5-9 years of age
2) No systemic illness
3) Angle’s class I molar relation or flush
terminal plane/ Mesial step in
children
4) Class I and class II carious lesions extending to dentin (ICDAS 4 &5) in
deciduous molars.
5) Primary first molars with at least 2/3rd roots present radio graphically.
6) No symptoms of periapical infection or irreversible pulpitis.
7) Antagonist primary molar present.
8) Detectable cervical constriction is present.
9) At least two surfaces and at least a part of occlusion are left intact.
10) Willingness to attend the appointments/parental consent.  
 
ExclusionCriteria 
Details  1) The teeth with signs and symptoms of irreversible pathology.
2) Children with any inter-canine relation other than class I.
3) Children with systemic conditions requiring special dental considerations.
4) Children who are not cooperative during the clinical examination.
5) Anterior- posterior cross bite.
6) Bleeding when probing around the tooth to be treated.
7) Children with previously diagnosed Temporomandibular joint disorder.
8) Children with obvious facial asymmetry or developmental anomalies
detected by inspection.
9) Children with Para-functional habits, tooth mobility, malocclusion. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Occlusal
Vertical Dimension (OVD) after placement of Stainless Steel Crown with Hall Technique  
0- pre treatment
1- immediately after the treatment
2- after 07 days of treatment
3- after 14 days of the treatment
4- after 28 days of the treatment
5- after 45 days of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
presence of Temporo-Mandibular Joint (TMJ) pain,
gingival health and the clinical and radiographic condition of the restored tooth
subsequent to the placement of stainless steel crowns  
0- pre treatment
1- immediately after the treatment
2- after 07 days of treatment
3- after 14 days of the treatment
4- after 28 days of the treatment
5- after 45 days of treatment  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   09/05/2025 
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="0"
Months="6"
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  

Dental caries in children is a widespread concern, with over 530 million children affected globally. In India, early childhood caries prevalence ranges from 27% to 58%. While conventional restorative methods like amalgam or stainless steel crowns (SSCs) with tooth preparation are commonly used, minimally invasive alternatives such as the Hall Technique are gaining popularity. Introduced by Dr. Nora Hall in 2006, the Hall Technique involves placing preformed metal crowns over carious primary molars without local anesthesia, tooth preparation, or caries removal. It aims to arrest caries progression by sealing off the biofilm and depriving it of substrates, thus reducing its cariogenicity.

Despite its advantages, the Hall Technique can cause temporary discrepancies in occlusion and increased occlusal vertical dimension (OVD), raising concerns about temporomandibular dysfunction (TM-D), gingival health, and long-term occlusal adaptation. Limited research exists comparing its efficacy and physiological effects with conventional SSC placement.

This randomized controlled study aims to assess and compare both techniques on several parameters: OVD changes, overbite restoration, TM-D symptoms, gingival health, treatment time, anxiety levels, and clinical and radiographic outcomes. Measurements such as OVD and overbite will be recorded at multiple intervals using digital photo analysis and Vernier calipers. TM-D will be assessed via a structured questionnaire, and gingival status will be evaluated using the Loe and Silness Gingival Index.

The study hypothesizes no significant difference between the two methods. By comprehensively evaluating both techniques, the research seeks to determine whether the Hall Technique can be a superior alternative to conventional methods in pediatric dentistry, especially in terms of efficiency, patient comfort, and long-term oral health outcomes.


 
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