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

ConditionsPostoperative Pain Pulp Necrosis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20-65

SponsorMehmet Adıgüzel

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

152 Participants

are divided into 4 treatment groups

Group A: Single-file rotary instrumentation (One Curve)Experimental treatment 1 intervention

Group B: Two-file rotary instrumentation (Perfect Minimally Invasive)Experimental treatment 1 intervention

Group C: Three-file rotary instrumentation (VDW Rotate)Experimental treatment 1 intervention

Group D: Four-file rotary instrumentation (Perfect Advanced Kit)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Postoperative Pain Intensity (VAS Score)

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."

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mehmet Adıgüzel

Lead sponsor

Mustafa Kemal University

Sponsor institution

Source ClinicalTrials.gov

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