A Clinical Study Comparing Two Non-Drilling Treatments for Decayed Primary Molars in Children With and Without Pulp Therapy

A Comparative Evaluation of Non-instrumental Endodontic Therapy (NIET) and Non-instrumental Endodontic Therapy with Non-Vital Pulp Therapy (NIET+NVPT) of Primary Molars: A Randomised Clinical Study. - MINIE Trial (Molar INfection therapy using Instrument-free Endodontics)

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/086791

Enrollment

Registered

2025-05-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Health Condition 1: K042- Pulp degeneration

Interventions

Intervention1: Non-instrumental Endodontic Therapy with Non-Vital Pulp Therapy (NIET+NVPT): A)NIET (Non-instrumental Endodontic Therapy) 1. No mechanical instrumentation: No files or reamers are used

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children between 6 to 10 years having deciduous molars with infected pulp. 2.Participants having primary molars diagnosed with pulp necrosis, chronic irreversible pulpitis, root resorption equal to or less than one-third in atleast one root. 3.Normal and healthy participants with no systemic disease. 4.Parents/Guardian who are willing to give a written informed consent and assent by participants will be included in the study.

Exclusion criteria

Exclusion criteria: 1.The participants who reported with a history of antibiotic intake in the past 1 month or anti inflamatory in the past 3 days and cases with previously initiated endodontic treatment. 2.Intraoperatively, where the haemostasis (application of saline dampened cotton pellet) could not be achieved within 8 minutes. 3.Teeth which are previously treated with pulpectomy procedures. 4.Participants with cellulitis / space infection. 5.Participants allergic to antibiotics used (Metronidazole, Ciprofloxacin, Clindamycin)

Design outcomes

Primary

Measure	Time frame
The current studys findings will provide insight into potential alternatives to extraction of teeth when there is a chronic abscess and root resorption of more than two thirds of the root in one or more of the roots. Understanding the effectiveness of NIET + NVPT therapy as a conservative strategy and keeping the tooth in the arch as a natural space maintainer would be the studys advantage.Timepoint: Clinical and radiographic success will be evaluated at a) Post tratment (Immediate) b) 1 months c) 3 months d) 6 months e) 9 months	—

Measure

Time frame

The current studys findings will provide insight into potential alternatives to extraction of teeth when there is a chronic abscess and root resorption of more than two thirds of the root in one or more of the roots. Understanding the effectiveness of NIET + NVPT therapy as a conservative strategy and keeping the tooth in the arch as a natural space maintainer would be the studys advantage.Timepoint: Clinical and radiographic success will be evaluated at a) Post tratment (Immediate) b) 1 months c) 3 months d) 6 months e) 9 months

—

Secondary

Measure	Time frame
Radiographic evaluation of development of tooth bud (Nolla stage) satisfactory or not.Timepoint: The clinical and radiographic success will be evaluated at 1, 3,6 and 9 months.	—

Countries

India

Contacts

Public ContactDr Anshula Deshpande

K.M. Shah dental college,Sumandeep Vidyapeeth,Waghodia Road, Waghodia, Piparia, Vadodara

dranshula@gmail.com7600916400

Outcome results

None listed

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