An interventional study of Fanta AF F one rotary files 20 taper 4 and Manual files (k files ,Mani, Inc., Japan). in Irreversible Pulpitis, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
To compare the post operative pain in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation, through a Randomized Clinical Trial.
The main question it aims to answer is:
Is there a difference in post operative pain when using single rotary file system versus manual instrumentation in pulpectomy of primary molars?
Endodontic procedures remain among the most commonly performed treatments following the diagnosis of pulpal inflammation or pathology. However, in primary teeth, endodontic treatment poses substantial difficulties owing to its complex anatomy and canal systems
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Patients:
Pre-operative Radiographic criteria:
Exclusion Criteria:
Patients:
Teeth:
Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, the root canal patency was checked for all the canals located using a size #10 (0.02%) k-file then a single rotary file (20 taper 4) will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at the rotational speed 300 rpm with torque set at the lowest level, irrigation with saline
Device: Fanta AF F one rotary files 20 taper 4
Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, manual files (k files, Mani, Inc., Japan) size 15,20,25,30 will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion, irrigation with saline
Device: Manual files (k files ,Mani, Inc., Japan).
Fanta AF F one rotary files 20 taper 4 single rotary file system
manual files (k files, Mani, Inc., Japan) size 15,20,25,30
Post-operative pain
: will be recorded by Asking the patient and/or guardian using a 4-point pain scale at 6, 12, 24, 48 and 72 hours And 1 week after treatment. The parent of each participant will receive 6 flashcards that include four faces and a word describing each face. 0 - None: No pain present. 1. \- Mild: Pain is present but not distracting; easily ignored. 2. \- Moderate: Pain is distracting; manageable but limits activities. 3. \- Severe: Intense pain; unable to concentrate, requires immediate action or medication
Time frame: At 6, 12, 24, 48 and 72 hours and 1 week after Treatment
child's behavior level
child's behavior level: will be recorded by using FRANKEL behavior rating Scale: rate 1 means definitely negative "refusal of treatment , fearfulness" rate 2 means negative "reluctance to accept treatment , uncooperative" rate 3 means positive "acceptance of treatment , patient follows the dentist's directions" rate 4 means definitely positive " good rapport with the dentist , laughter and enjoyment
Time frame: (Immediately after treatment)
Clinical Success
1. Absence of swelling will be recorded by visual examination 2. Absence of sinus or fistula: will be recorded by visual examination. 3. Pathologic mobility: will be recorded by mobility test (pressure using the end of two dental mirrors)
Time frame: ( At 3, 6, 12 months)
Instrumentation time
will be recorded using a stopwatch
Time frame: (During procedure start from anathesia till end of procedure)
The obturation quality
will be assessed using a radiograph(Using Coll and Sadrian criteria)
Time frame: (Immediately after treatment)
Plan to share: No — data is available with the corresponding author on reasonable request
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Cairo University