RecruitingNot ApplicableNCT07091981

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

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


Sponsor

Mehmet Adıgüzel

Enrollment

152 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 YearsMax Age: 65 Years

Inclusion Criteria7

  • 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 Criteria6

  • 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

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Interventions

DEVICEOneCurve Rotary File

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.

DEVICEPerfect Minimally Invasive Kit

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.

DEVICEVDW Rotate

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.

DEVICEPerfect Advanced Kit

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.


Locations(1)

Hatay Mustafa Kemal University Faculty of Dentistry

Antakya, Hatay, Turkey (Türkiye)

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NCT07091981


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