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

Not Applicable

Active, not recruiting

• 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

• Registration Number: NCT07019792
• Lead Sponsor: King Abdullah University Hospital

Brief 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

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.

Study Timeline

• Study Start: 2024-10-01
• Study First Submitted: 2025-05-27
• Status Verified: 2025-06
• Primary Completion: 2025-06
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-12
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-17
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ruba Mustafa; 🇯🇴 Irbid, Jordan