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IRCT20110823007402N8 IRCT 2022-03-04 Shiraz University of Medical Sciences 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 2022-04-03 anticipated 90 Complete https://irct.ir/trial/62112 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patient selection is based on the block randomization method with the use of randomization application. For the concealment, Sequentially numbered, sealed, opaque envelopes are used, Blinding description: The patient and the two researches who record the time of canal preparation and obturation, pain intensity, and child cooperation during the intervention and also the researcher who interprets the quality of obturation, clinical and radiographic success are blind to the group allocation. 3 Primary second molar with irreversible pulpitis. 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 and lubrication. Each file will be used for 4 teeth maximum. The prepared canals are then dried with paper cones (size 30-35) and filled with Endoflas (Sanlor and Cia. S. en C.S., Cali, Colombia) 1-2 mm shorter than the working length using injection method with Navitip (Ultradent, USA). Intervention 2: Intervention group: After access cavity preparation, the root canal will be prepared with rotary file m3-immatural. Sodium hypochlorite and normal saline and EDTA (if needed) is used for canal irrigation and lubrication. Each file will be used for 4 teeth maximum. The prepared canals are then dried with paper cones (size 30-35) and filled with Endoflas (Sanlor and Cia. S. en C.S., Cali, Colombia) 1-2 mm shorter than the working length using injection method with Navitip (Ultradent, USA). Intervention 3: Intervention group: After access cavity preparation, the root canal will be prepared with Rotary file iRace plus. Sodium hypochlorite and normal saline and EDTA (if needed) is used for canal irrigation and lubrication. Each file will be used for 4 teeth maximum. The prepared canals are then dried with paper cones (size 30-35) and filled with Endoflas (Sanlor and Cia. S. en C.S., Cali, Colombia) 1-2 mm shorter than the working length using injection method with Navitip (Ultradent, USA). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information exists
public Mahtab Memarpour
Zand street
Shiraz Iran (Islamic Republic of) 7196515878 +98 71 3628 0118 memarpour@sums.ac.ir Shiraz University of Medical Sciences scientific Mahtab Memarpour
Qomabad street, qasrodasht avenue
Shiraz Iran (Islamic Republic of) 7196515878 +98 71 3628 0118 memarpour@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) 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 5 years 8 years Both 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 K04.0 Pulpitis Treatment - Devices Treatment - Devices Treatment - Devices 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 and lubrication. Each file will be used for 4 teeth maximum. The prepared canals are then dried with paper cones (size 30-35) and filled with Endoflas (Sanlor and Cia. S. en C.S., Cali, Colombia) 1-2 mm shorter than the working length using injection method with Navitip (Ultradent, USA) Intervention group: After access cavity preparation, the root canal will be prepared with rotary file m3-immatural. Sodium hypochlorite and normal saline and EDTA (if needed) is used for canal irrigation and lubrication. Each file will be used for 4 teeth maximum. The prepared canals are then dried with paper cones (size 30-35) and filled with Endoflas (Sanlor and Cia. S. en C.S., Cali, Colombia) 1-2 mm shorter than the working length using injection method with Navitip (Ultradent, USA) Intervention group: After access cavity preparation, the root canal will be prepared with Rotary file iRace plus. Sodium hypochlorite and normal saline and EDTA (if needed) is used for canal irrigation and lubrication. Each file will be used for 4 teeth maximum. The prepared canals are then dried with paper cones (size 30-35) and filled with Endoflas (Sanlor and Cia. S. en C.S., Cali, Colombia) 1-2 mm shorter than the working length using injection method with Navitip (Ultradent, USA) 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. Shiraz University of Medical Sciences Approved 2022-01-05 Ethics committee of Shiraz Dental School Shiraz Dental School, Qom Abad street, Qasrodasht avenue Shiraz Fars Iran (Islamic Republic of)