| CTRI Number |
CTRI/2025/10/096330 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two methods for Placing Stainless Steel Crowns on Molars with Molar Incisor Hypomineralization in Children: A Randomized Clinical Trial |
|
Scientific Title of Study
|
Comparative Evaluation of clinical performance of two methods of Stainless Steel Crown placement ; Modified Hall vs Conventional in molars affected with Molar Incisor Hypomineralization: A Randomized Clinical Trial |
| 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 Sumedha Gupta |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Unit of Pedodontics and Preventive Dentistry
Oral Health Science Centre,
Post Graduate Institute of Medical Education and Research,
Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7678286077 |
| Fax |
|
| Email |
sumedhagupta96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Kapur |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Unit of Pedodontics and Preventive Dentistry
Oral Health Science Centre,
Post Graduate Institute of Medical Education and Research,
Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815966348 |
| Fax |
|
| Email |
draditikmalhotra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumedha Gupta |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Unit of Pedodontics and Preventive Dentistry
Oral Health Science Centre,
Post Graduate Institute of Medical Education and Research,
Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7678286077 |
| Fax |
|
| Email |
sumedhagupta96@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sumedha Gupta |
| Address |
Unit of Pedodontics and Preventive Dentistry
Oral Health Science Centre,
Post Graduate Institute of Medical Education and Research,
Chandigarh, India- 160012
|
| 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 Sumedha Gupta |
PGIMER |
Room 202 Unit of Pedodontics and Preventive Dentistry
Oral Health Science Centre,
Post Graduate Institute of Medical Education and Research,
Chandigarh, India- 160012
Chandigarh
CHANDIGARH |
7678286077
sumedhagupta96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K004||Disturbances in tooth formation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Stainless Steel Crown Technique |
Local anaesthesia is administered (2% lignocaine hydrochloride with 1:80,000 adrenaline). The tooth is cleaned, and SDF is applied followed by removal of soft caries using a spoon excavator. The cavity is restored with GIC. Crown selection is based on the mesiodistal width of the tooth. Tooth preparation includes 1.5 mm occlusal reduction and proximal reduction with a tapered fissure bur, followed by rounding of sharp line angles. The selected SSC is adjusted for occluso-gingival height if needed, contoured, and crimped. The crown is loaded with GIC and seated using finger pressure or by asking the child to bite. Excess GIC is removed. |
| Intervention |
Modified Hall Technique for Stainless steel crown placement |
In this technique, no local anesthesia is given and no tooth preparation is performed. An orthodontic separator is placed in proximal contact area to create interproximal space. The tooth is cleaned and any food debris is removed. Silver diamine fluoride (SDF) is applied, and soft caries is excavated with a spoon excavator. The cavity is restored with glass ionomer cement (GIC). The smallest suitable stainless steel crown (SSC) that fits snugly is selected, adjusted for occluso-gingival height if required, contoured, and crimped. The crown’s fit and occlusion are verified. The crown is loaded with GIC to two-thirds of its volume and seated on the tooth using finger pressure or by asking the child to bite into position. Excess cement is removed using a dental probe and floss. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Molar Incisor Hypomineralization (MIH) affected first permanent molar showing hypersensitivity, post eruptive enamel breakdown, atypical carious lesion, or unsatisfactory atypical restoration clinically indicated for full coverage restoration
Teeth with two or more surfaces involved, no clinical or radiographic signs of pulpal involvement, and remaining dentin thickness more than 2 mm
Children demonstrating positive or definitely positive behaviour as per the Frankl Behaviour Rating Scale |
|
| ExclusionCriteria |
| Details |
MIH affected molars with small, localized defects that can be managed using direct restorative procedures
Children presenting with developmental enamel defects other than MIH, such as amelogenesis imperfecta or severe fluorosis
Medically compromised children or those with systemic illnesses
Teeth indicated for root canal treatment or showing pulpal involvement
Children or parents unwilling to provide consent or refusing to participate in the study |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time taken for placement of Stainless steel crown in both the groups
Patient comfort using Visual analogue scale in both the groups
Retention of crown using Modified USPHS criteria over 6 months in both the study groups |
Baseline (Pre-operative), Immediate Post-operative, 1 month,3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in marginal adaptation and proximal contact using Modified USPHS 2005 criteria |
Immediate Post-operative, 1 month,3 months and 6 months |
| Changes in overbite and occlusal proximity using intraoral scanner and Dexis IS Scanflow software |
Baseline (Pre-operative), Immediate Post-operative, 1 month,3 months |
| Periodontal health measurement using silness and loe Plaque Index and Loe and Silness Gingival Index |
Baseline (Pre-operative), Immediate Post-operative, 1 month,3 months and 6 months |
| TMJ dysfunction using Helkimo index |
Baseline (Pre-operative), Immediate Post-operative, 1 month,3 months and 6 months |
| Radiographic changes including crown margins and root development |
Baseline (Pre-operative), Immediate Post-operative and 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
27/10/2025 |
| 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
|
This randomized clinical trial aims to compare the clinical performance of two methods of stainless steel crown (SSC) placement - the Modified Hall technique and the Conventional technique in permanent molars affected by Molar–Incisor Hypomineralization (MIH) in children. A total of 30 MIH affected molars will be randomly allocated into two groups using variable permuted block randomization. Group I will receive SSCs using the Modified Hall technique, and Group II will receive SSCs using the Conventional technique. All procedures will be performed under standardized clinical protocols. Follow-up assessments will be conducted at baseline, immediately post-operative, 1 month, 3 months and 6 months. Clinical outcomes such as crown retention, marginal integrity, proximal contact , gingival health, and occlusal settling will be evaluated. The study seeks to determine whether the minimally invasive Modified Hall technique can achieve clinical performance comparable or superior to the Conventional method thereby supporting a less invasive and more child-friendly restorative approach for MIH-affected molars. |