| 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
|
|
|
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
|
|
|
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
|
|
|
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. |