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Comparison of two methods for Placing Stainless Steel Crowns on Molars with Molar Incisor Hypomineralization in Children: A Randomized Clinical Trial

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096330
Enrollment
30
Registered
2025-10-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K004- Disturbances in tooth formation

Interventions

Intervention1: 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

Sponsors

Dr Sumedha Gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 groupsTimepoint: Baseline (Pre-operative), Immediate Post-operative, 1 month,3 months and 6 months

Secondary

MeasureTime frame
Changes in marginal adaptation and proximal contact using Modified USPHS 2005 criteriaTimepoint: Immediate Post-operative, 1 month,3 months and 6 months;Changes in overbite and occlusal proximity using intraoral scanner and Dexis IS Scanflow softwareTimepoint: Baseline (Pre-operative), Immediate Post-operative, 1 month,3 months;Periodontal health measurement using silness and loe Plaque Index and Loe and Silness Gingival IndexTimepoint: Baseline (Pre-operative), Immediate Post-operative, 1 month,3 months and 6 months;TMJ dysfunction using Helkimo indexTimepoint: Baseline (Pre-operative), Immediate Post-operative, 1 month,3 months and 6 months;Radiographic changes including crown margins and root developmentTimepoint: Baseline (Pre-operative), Immediate Post-operative and 6 months

Countries

India

Contacts

Public ContactDr Sumedha Gupta

Post Graduate Institute of Medical Education and Research, Chandigarh

draditikmalhotra@gmail.com9815966348

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026