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Effect of Rotary File Number on MB2 Canal Negotiation and Postoperative Pain

NCT07091981 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-08-24

No results posted yet for this study

Summary

This randomized controlled clinical trial aims to evaluate the effect of the number of rotary files on working length negotiation and postoperative pain in the second mesiobuccal (MB2) canals of maxillary first molars. Patients are assigned to one of four groups according to the number of rotary files used: single-, two-, three-, or four-file systems. Postoperative pain is assessed on each of the seven consecutive postoperative days (Days 1-7) using a visual analog scale (VAS), and working length negotiation success is recorded during canal instrumentation.

Conditions

  • Postoperative Pain
  • Asymptomatic Apical Periodontitis

Interventions

DEVICE

One Curve Rotary File

A single-file NiTi rotary instrument (25/.04) operated at 300 rpm and 2.5 Ncm torque. The instrument was applied directly to the MB2 canal without prior hand-file glide path preparation.

DEVICE

Perfect Super System Minimal Invasive Kit

A two-file rotary system consisting of a 10/.06 Shaper and a 25/.04 Finisher. The 10/.06 Shaper was used as the initial file to reach working length with a brushing motion, followed by the 25/.04 Finisher. Both files were operated at 300 rpm and 2.0 Ncm torque.

DEVICE

VDW Rotate

A three-file NiTi rotary system consisting of 15/.04, 20/.05, and 25/.04 files used sequentially with brushing-pecking motions in 2-3 mm increments. All files were operated at 300 rpm, with torque settings of 1.3 Ncm for the 15/.04 file, 2.1 Ncm for the 20/.05 file, and 2.3 Ncm for the 25/.04 file.

DEVICE

Perfect Super System Advanced Kit

A four-file NiTi rotary system consisting of a 10/.07 Opener, 10/.04 glider, 17/.05, and 25/.04 files. A crown-down sequence was used. The 10/.07 Opener was operated at 300 rpm and 2.5 Ncm torque, the 10/.04 glider at 250 rpm and 1.0 Ncm torque, and the 17/.05 and 25/.04 files at 300 rpm and 2.5 Ncm torque.

Sponsors & Collaborators

  • Mehmet Adıgüzel

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-18
Primary Completion
2025-11-19
Completion
2025-11-19

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07091981 on ClinicalTrials.gov