Postoperative Pain and Bacterial Reduction in Oval Canals After Instrumentation With Different Noval Rotary Files Systems

NCT07019792 — Not applicable, Active not recruiting, 120 participants, King Abdullah University Hospital

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Effect of Different Rotary Files Systems on Post-operative Pain and Bacterial Reduction in Lower Single Canal Posterior Teeth With Necrotic Pulp: Prospective Double Blinded Clinical Trial

Registry	NCT07019792
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, other
Enrollment	120 (Estimated)
Sponsor	King Abdullah University Hospital (Other); collaborators: Jordan University of Science and Technology
Conditions	Bacterial Count Reduction in Oval Canal After Rotary Instrumentation With Different Systems, Post-operative Pain After Rotary Instrumentation of Oval Canal With Different Systems
Interventions	Protaper ultimate, Truanatomy file system, Hyflex EDM, Xp shaper rise (Other)
Dates	start 2024-10-01, primary completion 2025-06-01 (estimated), completion 2025-07-01 (estimated), first posted 2025-06-13, last updated 2025-06-17
Locations	1 site in Jordan

-Summary

Postoperative pain after endodontic treatment can affect a patient's quality of life. It is reported that debris extrusion after the instrumentation technique can influence postoperative pain. As a result, the aim of this clinical trial is to compare the recent rotary systems (TruNatomy, ProTaper Ultimate, Hyflex EDM and XP- rise rotary files systems) in terms of apical extrusion defined by post-operative pain and their role in reducing the bacterial count inside the canal

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+Detailed description

One hundred and twenty lower premolar teeth will be included in the study(n=120). Teeth will be randomly assigned to one of the 4 groups(n=30). Preoprative pain will be recorded before root canal treatment. Postoperative pain will be recorded using visual analogue scale (VAS) at 6 hours,12 hours, 1day, 2 days, 3 days, 4 dayse and five days after the root canal treatment. Bacterial count before and after instrumentation will be determined using culturing methods to determine the bacterial count reduction.

+Arms and interventions

Arm	Type	Interventions
Multifile system: Protaper Ultimate	Experimental	Other: Protaper ultimate
Multiple files systems:TruNatomy	Experimental	Other: Truanatomy file system
Single file system: Hyflex EDM	Experimental	Other: Hyflex EDM
Single file system: Xp shaper rise	Experimental	Other: Xp shaper rise

Protaper ultimate (Other): Using Protaper Ultimate file system for canal preperation
Truanatomy file system (Other): Using Truanatomy file system for canal preperation
Hyflex EDM (Other): Using Hyflex file system for canal preperation
Xp shaper rise (Other): Using XPshaper rise system for canal preperation

+Outcome measures

Primary outcomes

Postoperative pain [at 6hours,12 hours, 24 hours, 2 days, 3 days, 4 days and five days after the root canal treatment]: Postoperative pain will be recorded using Visual Analogue Scale (VAS) at 6hours,12 hours, 24 hours, 2 days, 3 days, 4 days and five days after the root canal treatment Visual Analogue Scale (VAS) ranges from 0-10, the lower number the better outcome. 0= no pain 1-3= mild pain 4-6= moderate pain 7-10= sever pain
Bacterial count reduction [Sample will be collected before and directly after canal prepeartion]: Bacterial count sample will be collected before and after canal prepeartion

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* Medically fit
* Age ranges from 18-65 year
* Restorable teeth
* Necrotic teeth and symptoms free
* Lower premolars teeth (single canal posterior teeth)
* Necrotic pulps

Exclusion Criteria:

* Medically compromised
* Non-restorable teeth
* Open apex canal
* The past 12-hour history of analgesic intake before treatment.
* Patients with a history of antibiotics intake in the last 3 months before treatment.
* Pregnant females.
* Symptomatic patient.
* Pulpal diagnosis is not necrotic pulp.
* Retreatment cases

+Locations (1)

Facility	City	Country	Status
Ruba Mustafa	Irbid	Jordan