Rotary file system in primary teeth

Phase 3

• Conditions: Primary second molar with irreversible pulpitis.; Pulpitis; K04.0

• Registration Number: IRCT20110823007402N8
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 8 March 2022

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 90

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.