FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094889 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 15/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study Comparing the progression of New Cavities on Adjacent Surfaces of those Teeth Fixed Using the Hall Technique Versus Modern White Fillings 
Scientific Title of Study   Comparative evaluation of caries progression on tooth surfaces adjacent to primary molars treated with the Hall technique versus nano-filled composite restorations : A randomized clinical 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 Ritambhra Dikshit 
Designation  Junior Resident -1 
Affiliation  King George Medical College  
Address  Department of Paediatric and Preventive dentistry ,4th floor New Dental building , Shahmina road , KGMU Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9457062933  
Fax    
Email  ritambhradixit@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Afroz Alam Ansari  
Designation  Professor 
Affiliation  King George Medical College 
Address  Department of Paediatric and Preventive dentistry ,4th floor New Dental building , Shahmina road , KGMU Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9335166662  
Fax    
Email  afrozalamansari@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Afroz Alam Ansari  
Designation  Professor  
Affiliation  King George Medical College 
Address  Department of Paediatric and Preventive dentistry ,4th floor New Dental building , Shahmina road , KGMU Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9335166662  
Fax    
Email  afrozalamansari@rediffmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr Ritambhra Dikshit  
Address  Department of Paediatric and Preventive Dentistry ,4th floor New Dental Building Shahmina road KGMU Lucknow Pincode 226003 
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 Ritambhra Dikshit  King George Medical University   PG clinic ,Room no.4 ,4th floor ,Department of Paediatric and Preventive Dentistry
Lucknow
UTTAR PRADESH 
09457062933

ritambhradixit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King george medical university U.P , Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K026||Dental caries on smooth surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Composite Restoration  Primary molars restored with composite resin restorations following conventional preparation techniques to remove infected dentin before restoration.The total duration of such intervention is approximately 20–30 minutes per tooth. 
Comparator Agent  stainless steel crown   S crowns will be fitted on primary molars without removing any tooth structure, sealing the carious lesion completely. The total duration of such intervention is approximately 15-20 minutes per tooth. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Patients with at least one primary molar presenting multisurface or occluso-proximal dentine caries lesions.
2. Adjacent tooth surfaces classified as sound or initial stage carious lesions based on ICDAS merged categories at baseline.
3. Cooperative children rated as definitely positive or positive on the Frankl Behavioural Rating Scale.
4. Parents or guardians who provide consent for participation in the study.

 
 
ExclusionCriteria 
Details  1. Patients with primary molars requiring pulp therapy or endodontic treatment.
2. Patients with poor oral hygiene compliance or those unlikely to adhere to follow-up schedules.
3. Patients with carious primary molars without adjacent teeth present.
4. Patients with metabolic disorders or medically compromised conditions
5. Patients who are not willing to participate in the study
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
• Change in carious lesion status: Evaluation of the progression or arrest of caries on adjacent tooth surfaces.  • T0 (baseline), T1 (at 6 months post intervention) and T2
(at 12 months post intervention).
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Restoration survival rate: Assessment of restoration longevity and integrity over the 12-month follow-up period.
2. Patient behavior during treatment
3. Patient satisfaction
4. Patient-reported pain and discomfort: Assessed immediately after treatment using a visual analog scale (VAS).
 
immediately post opt and at 12 month 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
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   Phase 4 
Date of First Enrollment (India)   30/09/2025 
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="1"
Months="4"
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  

Introduction
Dental caries is a widespread chronic disease caused by the interaction of dietary sugars, bacteria, and host factors leading to tooth demineralization. Its progression is driven by an imbalance between demineralization and remineralization. Prevention and management are vital to oral health and quality of life. Conventional management relied on removing carious dentin and restoring with materials such as composites, glass ionomer cements, and amalgam but this often required significant tooth structure removal. The Hall technique is a minimally invasive approach in which a preformed metal crown is placed over a carious primary molar without tooth preparation. It seals the lesion, inactivates bacteria, and arrests caries progression. Literature supports its effectiveness, but little evidence exists on its impact on adjacent tooth surfaces compared to modern materials like nano filled composites.

Aim
To compare and evaluate caries progression on tooth surfaces adjacent to primary molars treated with the Hall technique versus nano filled composite restoration.

Objectives
The primary objective is to compare progression of caries on adjacent tooth surfaces. Secondary objectives are to evaluate survival rate of treatments and assess patient acceptance and satisfaction.

Hypothesis
There is a significant difference in efficacy of the Hall technique and nano filled composite restorations in preventing progression of caries on adjacent surfaces.

Review of Literature
Studies from 2019 to 2024 have compared the Hall technique with conventional restorations and atraumatic restorative treatment. Findings generally show higher success rates, lower failure rates, and good acceptance for the Hall technique. Research on nanofilled composites shows clinically acceptable results and potential advantages in restoring primary molars.

Methodology
The randomized controlled study will be conducted in the Department of Paediatric and Preventive Dentistry at King Georges Medical University Lucknow. Ethical approval and informed consent will be obtained. Participants will be children aged five to nine years with primary molars having occluso proximal caries. Exclusion applies to those needing pulp therapy, with poor compliance, lacking adjacent teeth, with systemic issues, or unwilling to participate.

The sample size is thirty nine per group after adjustment for attrition. Participants will be randomly allocated into two groups. Group A will receive Hall technique treatment with preformed metal crowns. Group B will receive nano filled composite restorations with cavity preparation and bonding.

Outcomes
The primary outcome is change in carious lesion status on adjacent tooth surfaces assessed at baseline six months and twelve months using ICDAS. Secondary outcomes are restoration survival rate at twelve months, patient behavior during treatment, patient satisfaction, and reported pain or discomfort.

Data Collection and Analysis
Caries status will be analyzed using non parametric tests. Survival rate will be analyzed with Kaplan Meier survival analysis and log rank test. Patient satisfaction and acceptability will be summarized descriptively. A probability value less than 0.05 will be considered statistically significant.


 
Close