Skip to content

Rotary file system in primary teeth

Comparison of two rotary file systems with manual instrumentation for root canal preparation in primary teeth: a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110823007402N8
Enrollment
90
Registered
2022-03-04
Start date
2022-04-03
Completion date
Unknown
Last updated
2022-03-08

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

Conditions

Primary second molar with irreversible pulpitis. Pulpitis

Interventions

Intervention 1: Control group: After access cavity preparation, the root canal will be prepared with hand file. Sodium hypochlorite and normal saline and EDTA (if needed) is used for canal irrigation

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 8 Years

Inclusion criteria

Inclusion criteria: clinical examination reveals carious lesion in primary molar without extension to the root vital signs during the intervention will be checked and only vital teeth are included in the study All cases report signs of irreversible pulpitis with chief complaint of spontaneous pain in the past few days. This pain is exacerbated with clod or warm stimuli and the patient requires analgesic consumption. minimum of two thirds of root remainings Children of 5-8 years old

Exclusion criteria

Exclusion criteria: children with systemic diseases or with special healthcare needs Children with poor oral hygiene or periodontal disease radiographic signs of internal or external root resorption, root canal calcification, non-restorabale teeth

Design outcomes

Primary

MeasureTime frame
Measurement of time of canal preparation with chronometer. Timepoint: From initiation to the end of filing. Method of measurement: with chronometer.;Measurement of time of canal obturation with chronometer. Timepoint: From initiation to the end of obturation. Method of measurement: with chronometer.;Patient cooperation. Timepoint: during intervention. Method of measurement: Frankel and FLACC criteria for patient cooperation.;Intensity and duration of pain. Timepoint: 6, 12, 24, 48, 72 hours and 1 week after intervention. Method of measurement: four point pain intensity.;Clinical success. Timepoint: 3, 6, 12, and 18 months after treatment. Method of measurement: without signs of pain, abscess, redness, tenderness, mobility, swelling, sinus tract, and pus are considered successful.;Radiographic success. Timepoint: 3, 6, 12, and 18 months after treatment. Method of measurement: absence of pathologic findings, radiolucency in furca or periapical.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahtab Memarpour

Shiraz University of Medical Sciences

memarpour@sums.ac.ir+98 71 3628 0118

Outcome results

None listed

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