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CTRI Number  CTRI/2025/08/092251 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 10/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative Clinical Evaluation of Stainless Steel Crown Restoration Using Three Diffrent techniques for managing carious primary molars. 
Scientific Title of Study   Comparative Clinical Evaluation of Stainless Steel Crown Restoration Using Conventional Technique, Hall Technique and Modified Hall Technique for Managing Carious Primary Molars An In Vivo 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 AKSHAYDEEP K A 
Designation  POST GRADUATE STUDENT 
Affiliation  Guru Nanak Dev Dental College and Research Institute 
Address  Room no 5, Department of Peditric and Preventive Dentistry, Guru Nanak Dev Dental College and Research Institute, Sunam, Sangrur

Sangrur
PUNJAB
148028
India 
Phone  7012255114  
Fax    
Email  drdeepkidodontist222@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Varinder Goyal 
Designation  Professor and Head of Department 
Affiliation  Guru Nanak Dev Dental College and Research Institute 
Address  Room no 5, Department of Peditric and Preventive Dentistry, Guru Nanak Dev Dental College and Research Institute, Sunam, Sangrur

Sangrur
PUNJAB
148028
India 
Phone  7012255114  
Fax    
Email  virinderg@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr AKSHAYDEEP K A 
Designation  Post Graduate Student 
Affiliation  Guru Nanak Dev Dental College and Research Institute 
Address  Room no 5, Department of Peditric and Preventive Dentistry, Guru Nanak Dev Dental College and Research Institute, Sunam, Sangrur

Sangrur
PUNJAB
148028
India 
Phone  7012255114  
Fax    
Email  drdeepkidodontist222@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry, Guru Nanak Dev Dental College and Research Institute, Sunam, Sangrur, Punjab. Pin: 148028 
 
Primary Sponsor  
Name  Dr AKSHAYDEEP K A 
Address  Department of Peditric and Preventive Dentistry, Guru Nanak Dev Dental College and Research Institute, Sunam, Sangrur, Punjab. Pin:148028 
Type of Sponsor  Research institution 
 
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 AKSHAYDEEP K A  Guru Nanak Dev Dental College and Reserch Institute  Room no 5, Department of Peditric and Preventive Dentistry, GNDDC, Sunam, Sangrur
Sangrur
PUNJAB 		 7012255114

drdeepkidodontist222@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTIE  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  CASE SELECTION AND CARIES REMOVAL After selection of the case according to the inclusion criteria complete caries removal will be done with round bur (BR-45) followed by restoration of the tooth by restorative Glass ionomer cement. TOOTH PREPARATION Reduction of buccal and lingual surface by 0.5mm upto occlusal third by flat end tapered diamond bur (TF-11) will be done followed by reduction of proximal surfaces by tapered fissured diamond bur(TC-21) Reduction of occlusal surface by about 1-1.5mm including the central groove using a flame shape or tapered diamond bur(FO-25/TF-11) will be done. All the undercuts on preparation will be removed properly. CROWN SELECTION After tooth preparation, crown of appropriate size will be selected, and the passive fit of the crown will be checked. Trimming of the crown will be done by using crown cutting scissor or micromotor and hand piece with diamond cutting burs. For better adaptation of crown, bucco-lingual smile and mesio-distal furrow will be made if necessary. CROWN CEMENTATION The prepared tooth will be thoroughly cleaned with water spray and dried. Prepared tooth will be kept free from any blood or residues of saliva and gingival fluid. The finished crown will be cemented over the prepared tooth using a luting Cement. Occlusion will be checked and adjusted accordingly. 
Comparator Agent  Hall technique  CASE SELECTION Proper case selection will be done according to the inclusion criteria and no caries will be removed. TOOTH SEPRATION Separators will be placed inter-proximally on both sides of the carious tooth for about 24 hours. CROWN SELECTION After tooth separation, crown of appropriate size will be selected, and the passive fit of the crown will be checked. Trimming of the crown will be done by crown cutting scissors or by using micromotor and hand piece with diamond cutting burs according to the requirement. CROWN CEMENTATION After fit check, crown will be dried and luted with luting cement. 
Comparator Agent  Modified Hall technique  CASE SELECTION Case will be selected according to the inclusion criteria and no caries removal will be done. TOOTH SEPRATION Slight interproximal reduction will be done on both sides of the carious tooth for creating a space for the crown with tapered fissured bur(TF-11). CROWN SELECTION After tooth separation, crown of appropriate size will be selected and the passive fit of the crown will be checked. if necessary, adjustments like trimming and crimping will be done. CROWN CEMENTATION After checking the fit of the crown, crown will be dried and luted with luting cement. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.Teeth with large occlusal caries
2.Teeth with occlusal caries involving marginal ridge
3.Teeth with multi surface caries without any clinical signs and symptoms of pulpal involvement.
4.Patients with high caries susceptibility.
5.Teeth with repeated restoration failure
6.Presence of at least two-third root structure radiographically.
7.Good general health
8.High risk of caries incidence
9.Children with behavior scale of 1 and 2 (Frankel’s rating scale)
 
 
ExclusionCriteria 
Details  1.Teeth with signs or symptoms of irreversible pulpitis or dental abscess
2.Teeth with clinical or radiographic signs of pulpal exposure or peri-radicular pathology
3.Crowns severely destructed with caries, which considered non-restorable
4.Fistula or /and mobility in the tooth
5.Doubtful presence of an intact dentin layer between the lesion and pulp
6.Teeth showing sign and symptoms of pathological internal and external resorption
7.Medically compromised patient
8.Very young children who do not understand the procedure or tolerate biting the crown into its position without local anesthesia
9.Children with behavior scale of 3 and 4 (Frankel’s rating scale) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Best technique of crown placement will be evaluated on the basis of retention, gingival health and plaque accumulation  At baseline, 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Parental satisfaction will also be notted.  At baseline, 3 months & 6 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/08/2025 
Date of Study Completion (India) 01/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Stainless steel crowns are used for full coverage restoration in paediatric dentistry because of their biocompatibility, resistance and strength and other usefull outcomes. The aim of the present study is to compare and clinical evaluate the stainless steel crown restoration using conventional technique, hall technique and modified hall technique for carious primary molars and evaluating these technique on the basis of retention, gingival index, plaque index and parental satisfaction. The children aged 4 to 10 years with 90 primary molar teeth indicated for crown will be selected and randomly divided into three groups: Group I: Stainless steel crowns using conventional technique; Group II: Stainless steel crowns using Standard Hall technique; Group III: Stainless Steel Crowns using Modified Hall technique. The crowns will be placed after that the tooth will be clinically analyzed according to the evaluation criteria and the data will be further tabulated and statistically analyzed. 

 
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