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Comparative Evaluation of Hand and Rotary Files on Instrumentation Time and Postoperative Pain Following Pulpectomy in Primary Mandibular Molars of Children Aged 4 8 Years: A Randomized Controlled Trial

Comparative evaluation of Pro AF Baby Gold files, Kids E files (Rainbow NiTi), and hand K-files (NiTi Flex) on instrumentation time and postoperative pain following pulpectomy in primary mandibular molars of children aged 4 to 8 years: a randomized controlled trial. - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106952
Enrollment
75
Registered
2026-03-27
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

None listed

Interventions

Intervention1: Group II: - (Pro AF baby gold files) (Dentalyze) Group III: - (Kids e files, rainbow Niti ) (Kids-e-dental): rotary files Control Intervention1: Group I: Hand K-files (NITI flex) (1

Sponsors

Dhanashri Holey
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Primary mandibular molars with irreversible pulpitis or with non-vital pulp 2. Children with no history of analgesic usage within 12 hours prior to the procedure 3. The child should be in good health with no history of major systemic illness or allergies. 4. Patient should be between 4 and 8 years of age. 5. Patients exhibiting Frankl s behavior rating scale score of 3 (positive (+)) and 4 definitely positive (++). 6. Absence of internal or cervical pathologic root resorption. 7. A minimum of two-thirds of the remaining root length 8. A tooth structure strong enough to hold a rubber dam. 9. Co-operative children and parents willing to follow the instructions and report for follow-up

Exclusion criteria

Exclusion criteria: 1.Children with systemic illness such as congenital or rheumatic heart disease, hepatitis, and leukemia etc. 2. Clinically, mobile tooth, discolored tooth, and a tooth with sinus opening, fistula, or abscess. 3. Children lacking the cooperative ability. 4. Teeth with internal or external root resorption. 5. Teeth exhibiting pulpal floor perforation. 6. Radiolucent area in the furcation or peri radicular region 7. Patient/guardian not ready to give consent

Design outcomes

Primary

MeasureTime frame
The study aims to compare instrumentation time and postoperative pain during pulpectomy in primary mandibular molars of children aged 4 8 years using three file systems: Hand K-files (NiTi Flex), Pro AF Baby Gold files, and Kids E-files, with pain assessed up to one week using a four-point Verbal Rating Scale.Timepoint: At baseline till seventy two hpurs—

Secondary

MeasureTime frame
nilTimepoint: nil—

Countries

India

Contacts

Public ContactDHANASHRI SATISH HOLEY

Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur

arunsajju@gmail.com9146768016

Outcome results

None listed

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