Effect of Rotary File Number on MB2 Canal Negotiation and Postoperative Pain (MB2-PAIN)

Mehmet Adıgüzel

Status: Enrolling

Conditions: Postoperative Pain; Pulp Necrosis

Treatments: Device: OneCurve Rotary File; Device: VDW Rotate; Device: Perfect Minimally Invasive Kit; Device: Perfect Advanced Kit

Study type: Interventional

Funder types: Other

Identifiers

NCT07091981

2025/M08-D38 (Other Identifier)

HMKU-MB2Pain-RCT2025

Details and patient eligibility

About

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.

Enrollment: 152 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

152 participants in 4 patient groups

Single-file rotary instrumentation (One Curve)

Experimental group

Description:

Patients received root canal treatment using a single-file rotary system (OneCurve) in the MB2 canals of maxillary first molars. OneCurve 25/.04 rotary file was used at 300 rpm and 2.5 Ncm torque.

Treatment:

Device: OneCurve Rotary File

Two-file rotary instrumentation (Perfect Minimally Invasive)

Experimental group

Description:

Root canal treatment was performed using a two-file system (Perfect Minimally Invasive; Perfect Medical Instruments Co. Ltd, China). A 10/.06 Shaper file was used with brushing motion in the coronal and middle thirds, followed by a 25/.04 Finisher file in the apical third. Files operated at 300 rpm and 2.0-2.5 Ncm torque under continuous irrigation.

Treatment:

Device: Perfect Minimally Invasive Kit

Three-file rotary instrumentation (VDW Rotate)

Experimental group

Description:

Root canal instrumentation was performed using a three-file system (VDW Rotate; VDW GmbH, Germany). Instrumentation was performed sequentially using 15/.04, 20/.05, and 25/.04 files for the coronal, middle, and apical thirds, respectively, with brushing-pecking motions in 2-3 mm increments under continuous irrigation. Files were operated at 300 rpm and 1.8 Ncm torque in the MB2 canal of maxillary first molars.

Treatment:

Device: VDW Rotate

Four-file rotary instrumentation (Perfect Advanced Kit)

Experimental group

Description:

Root canal instrumentation was performed using a four-file rotary system (Perfect Advanced Kit; Perfect Medical Instruments Co. Ltd, China). Coronal enlargement was initiated with a 10/.07 Opener file at 300 rpm and 2.5 Ncm torque. A 10/.04 file was then used at 250 rpm and 2.0 Ncm torque to reach the apical third. Final shaping was completed with 17/.05 and 25/.04 files at 300 rpm and 2.5 Ncm torque. A crown-down technique was applied using brushing-pecking motions in 2-3 mm increments. After each file, the canal was irrigated thoroughly and file flutes were cleaned to prevent debris accumulation.

Treatment:

Device: Perfect Advanced Kit