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Comparison of 3 different Rotary File Systems with hand files.

Cormparative Eva!uation of Clinical Outcome, Radiographie Success and Antimicrobiat Efficacy of Hand Files With Reciprocating Handpiece V/s 3 Different Rotary File Systems in Primary Teeth: A Randomized Clinical Study.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076924
Enrollment
200
Registered
2024-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Hand Files: Patient selection as per the inclusion and exclusion criteria, Randomization, Allocation, oral prophylaxis, Administration of local anaesthesia will be done, fo

Sponsors

Department of Pedodontics
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Absence of periapical or interradicular radiolucency. Radiographic absence of external or internal pathological resorption. Primary teeth with at least 2/3 of the root intact. Adequate tooth structure to support a rubber dam. Children with Frankle + and++ Behaviour

Exclusion criteria

Exclusion criteria: Any subject that does not fall under the inclusion criteria were excluded Parents not willing to give consent Children with Special Health Care needs (SHCN) Children with systemic diseases

Design outcomes

Primary

MeasureTime frame
The primary outcome is the success of the treatment. Success will be defined by the absence of major failure Clinically and Radiographically. i.e. absence of pain, abscess, swelling, interfurcal radiolucency, root resorption etc. and patient and/or parent acceptance will be clinically evaluated at baseline and at last appointmentTimepoint: evaluation will be carried out at baseline, 3 months, 6 months and 12 months

Secondary

MeasureTime frame
The secondary outcome is the success of the treatment Success will be defined by the evaluation of anti-microbial efficacy. i.e. reduction in aerobic and/or anaerobic microbial count (CFU)Timepoint: 12 months

Countries

India

Contacts

Public ContactAmol Patil

Department of Pedodontics, M a Rangoonwala Dental College

amolpatil2526@gmail.com09561042279

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026