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
|
|
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
|
|
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. |