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Completed

NCT Number: NCT07091981

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

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.

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Key information

Conditions

Postoperative Pain Asymptomatic Apical Periodontitis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hatay Mustafa Kemal University Faculty of Dentistry

Antakya, Hatay, 31006, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Systemically healthy individuals aged between 20 and 65 years
  • Requiring primary endodontic treatment of maxillary first molars
  • Diagnosis of asymptomatic apical periodontitis based on clinical and radiographic findings
  • Presence of a second mesiobuccal (MB2) canal in the maxillary first molar
  • Absence of preoperative pain or symptoms
  • Teeth with periapical lesions smaller than 5 mm in diameter
  • Ability to comply with follow-up visits and effectively communicate during the treatment process

Exclusion criteria

  • Presence of symptomatic apical periodontitis or acute apical abscess
  • Need for retreatment of previously treated teeth
  • Use of medications such as narcotics, antibiotics, sedatives, or antidepressants within one week prior to treatment
  • Presence of a sinus tract, periapical abscess, or facial cellulitis
  • Pregnancy
  • Inability to understand or follow the study instructions

Treatment and study plan

One Curve Rotary File

Device

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.

Perfect Super System Minimal Invasive Kit

Device

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.

VDW Rotate

Device

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.

Perfect Super System Advanced Kit

Device

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.

Primary outcomes

  1. Postoperative Pain Intensity (VAS Score)

    Time frame: Daily assessment for 7 consecutive days following treatment (Days 1-7)

    Postoperative pain will be assessed using a 100-mm Visual Analog Scale (VAS), where 0 mm represents "no pain" and 100 mm represents "worst possible pain imaginable."

Sponsors and collaborators

Lead sponsor

Mehmet Adıgüzel

Other

Registry information

Official study title

Effect of Number of Rotary Instruments on Negotiating Second Mesiobuccal Canals to Working Length and on Postoperative Pain: A Randomized Clinical Trial

Acronym: MB2-PAIN

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2025
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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