Comparing Treatments for Closing Open Apex in Non-Vital Young Teeth: A Study of MTA, Biodentin, and Calcium Hydroxide

Effectiveness of MTA, Bio dentin, and Calcium Hydroxide in Open Apex Closure of Non vital Immature Teeth; A Randomised Control Trial. - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078349

Enrollment

Registered

2024-12-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

None listed

Interventions

Intervention1: Study Group: Group 2 (Intervention) - Biodentine (Septodont, France) treatment for 6 months. Group 3 (Intervention) - RC Cal (Prime Dental products, Mumbai, India) treatment for 6 month

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 9–14 years with non-vital, immature anterior teeth with open apex and more than 75% root development Teeth with no signs of periapical pathology or mobility Children accompanied with parents who are willing for an informed consent.

Exclusion criteria

Exclusion criteria: Children who are extremely uncooperative. Teeth with closed apex and showing signs of periapical pathology, that would require immediate intervention beyond the study protocol. Children with systemic diseases (e.g., diabetes, Congenital Heart disease, immune-compromising conditions) that may impair healing or affect the study outcomes. Children with known allergies to any of the materials (MTA, Biodentin, or calcium hydroxide). Children with parents/guardians unable or unwilling to comply with follow-up visits or study requirements. Children who had undergone previous attempts at apexification or similar treatments using the study materials.

Design outcomes

Primary

Measure	Time frame
Successful apical closure of non-vital, immature anterior teeth with open apices measured through radiographic evaluation at follow-up intervals (1, 3, and 6 months). Complete apical barrier formation as an indicator of material effectiveness.Comparison of MTA, Biodentine, and bioceramics for reliable and sustainable root-end closure in pediatric patients. Timepoint: Radiographic evaluation at follow-up intervals (1, 3, and 6 months).	—

Measure

Time frame

Successful apical closure of non-vital, immature anterior teeth with open apices measured through radiographic evaluation at follow-up intervals (1, 3, and 6 months). Complete apical barrier formation as an indicator of material effectiveness.Comparison of MTA, Biodentine, and bioceramics for reliable and sustainable root-end closure in pediatric patients. Timepoint: Radiographic evaluation at follow-up intervals (1, 3, and 6 months).

—

Secondary

Measure	Time frame
Evaluation in root canal wall thickening. Absence of clinical symptoms, including pain and swelling. Monitoring of post-treatment complications (e.g., reinfection, root fractures). Evaluation of pain assessment levels. Assessment of material durability and safety for maintaining root integrity and reducing future complications. Timepoint: 1, 3, 6 months.	—

Countries

India

Contacts

Public ContactDr Ramesh R

Saveetha Dental College and Hospital

rameshr.sdc@saveetha.com9895725236

Outcome results