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Recruiting NCT07091981

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

No phase Interventional Postoperative Pain Pulp Necrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OneCurve Rotary File, Perfect Minimally Invasive Kit, VDW Rotate, Perfect Advanced Kit.
Who it may be relevant to
Registry conditions: Postoperative Pain, Pulp Necrosis. Basic parameters: 20 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device OneCurve 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.
  • Device Perfect 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.
  • Device VDW 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.
  • Device Perfect 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.

Primary outcome measures

  • Postoperative Pain Intensity (VAS Score) [Time frame: Daily assessment for 7 consecutive days following treatment (Days 1-7)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Hatay Mustafa Kemal University Faculty of Dentistry — Antakya

Identifiers

NCT: NCT07091981 · HMKU-MB2Pain-RCT2025 · 2025/M08-D38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗