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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 Dental Pulp Diseases Dental Pulp Necrosis Necrosis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Pulp Necrosis Signs and Symptoms Stomatognathic Diseases Tooth Diseases

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)

Location status: Recruiting

Location contact

Mehmet Adıgüzel, DDS, PhD

CONTACT

[email protected]

05447608920

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 and pulp necrosis based on clinical and radiographic findings
  • Presence of a second mesiobuccal (MB2) canal in the maxillary first molar
  • Absence of or only minimal preoperative pain or symptoms
  • 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
  • Retreatment cases (teeth previously treated endodontically)
  • 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 or breastfeeding
  • Inability to understand or follow the study instructions

Treatment and study plan

OneCurve Rotary File

Device

A single-file NiTi system (25/.04) operated at 300 rpm and 2.5 Ncm torque. Applied directly to the MB2 canal without prior hand instrumentation.

Perfect Minimally Invasive Kit

Device

Two-file system using 10/.06 Shaper for coronal/middle thirds and 25/.04 Finisher for apical third. Operated at 300 rpm and 2.0-2.5 Ncm torque.

VDW Rotate

Device

Three-file NiTi rotary system (15/.04, 20/.05, 25/.04) used sequentially for coronal, middle, and apical thirds. Applied with brushing-pecking motion in 2-3 mm increments under continuous irrigation. Operated at 300 rpm and 1.8 Ncm torque.

Perfect Advanced Kit

Device

NiTi rotary file system including 10/.07 Opener, 10/.04, 17/.05, and 25/.04 files. Used in crown-down sequence with rpm and torque settings ranging from 250-300 rpm and 2.0-2.5 Ncm. Brushing-pecking motion and continuous irrigation were applied during instrumentation.

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."

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet A. Adıgüzel, DDS, PhD

CONTACT

[email protected]

+90 5447608920

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 1, 2025

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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