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

NCT07091981 | Completed

• 2 other identifiers: HMKU-MB2Pain-RCT20252025/M08-D38
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain; Asymptomatic Apical Periodontitis

Keywords

VAS Pain Scale; Endodontic Treatment; Rotary Files

Outcome Measures

Primary Outcomes (1)

• 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."

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

Study Arms (4)

Single-file rotary instrumentation (One Curve)

EXPERIMENTAL

Root canal instrumentation was performed using a single-file rotary system (One Curve; Micro-Mega, Besançon, France). A 25/.04 One Curve file was used at 300 rpm and 2.5 Ncm torque with gentle pecking motions. The file was cleaned and withdrawn every 2-3 mm during advancement to the full working length.

Device: One Curve Rotary File

Two-file rotary instrumentation (Perfect Super System Minimal Invasive)

EXPERIMENTAL

Root canal instrumentation was performed using a two-file rotary system (Perfect Super System Minimal Invasive; Perfect Medical Instruments Co. Ltd, Shenzhen, China). A 10/.06 Shaper file was used as an initial file to reach working length with a brushing motion, followed by a 25/.04 Finisher file. Both files were operated at 300 rpm and 2.0 Ncm torque.

Device: Perfect Super System Minimal Invasive Kit

Three-file rotary instrumentation (VDW Rotate)

EXPERIMENTAL

Root canal instrumentation was performed using a three-file rotary system (VDW Rotate; VDW GmbH, Munich, Germany). Instrumentation was performed sequentially using 15/.04, 20/.05, and 25/.04 files with brushing-pecking motions in 2-3 mm increments. All files were operated at 300 rpm, with torque settings of 1.3 Ncm for the 15/.04 file, 2.1 Ncm for the 20/.05 file, and 2.3 Ncm for the 25/.04 file.

Device: VDW Rotate

Four-file rotary instrumentation (Perfect Super System Advanced Kit)

EXPERIMENTAL

Root canal instrumentation was performed using a four-file rotary system (Perfect Super System Advanced Kit; Perfect Medical Instruments Co. Ltd, Shenzhen, China). A crown-down preparation was performed up to the apical third using a 10/.07 Opener file at 300 rpm and 2.5 Ncm torque. A 10/.04 glider file was then used at 250 rpm and 1.0 Ncm torque to reach the root apex and prepare the apical third. Instrumentation was completed using 17/.05 and 25/.04 files, both operated at 300 rpm and 2.5 Ncm torque.

Device: Perfect Super System Advanced Kit

Interventions

VDW Rotate DEVICE

A three-file NiTi rotary system consisting of 15/.04, 20/.05, and 25/.04 files used sequentially with brushing-pecking motions in 2-3 mm increments. All files were operated at 300 rpm, with torque settings of 1.3 Ncm for the 15/.04 file, 2.1 Ncm for the 20/.05 file, and 2.3 Ncm for the 25/.04 file.

Three-file rotary instrumentation (VDW Rotate)

One Curve Rotary File DEVICE

A single-file NiTi rotary instrument (25/.04) operated at 300 rpm and 2.5 Ncm torque. The instrument was applied directly to the MB2 canal without prior hand-file glide path preparation.

Single-file rotary instrumentation (One Curve)

Perfect Super System Minimal Invasive Kit DEVICE

A two-file rotary system consisting of a 10/.06 Shaper and a 25/.04 Finisher. The 10/.06 Shaper was used as the initial file to reach working length with a brushing motion, followed by the 25/.04 Finisher. Both files were operated at 300 rpm and 2.0 Ncm torque.

Two-file rotary instrumentation (Perfect Super System Minimal Invasive)

Perfect Super System Advanced Kit DEVICE

A four-file NiTi rotary system consisting of a 10/.07 Opener, 10/.04 glider, 17/.05, and 25/.04 files. A crown-down sequence was used. The 10/.07 Opener was operated at 300 rpm and 2.5 Ncm torque, the 10/.04 glider at 250 rpm and 1.0 Ncm torque, and the 17/.05 and 25/.04 files at 300 rpm and 2.5 Ncm torque.

Four-file rotary instrumentation (Perfect Super System Advanced Kit)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy individuals aged between 20 and 65 years
• Requiring primary endodontic treatment of maxillary first molars
• Diagnosis of asymptomatic apical periodontitis based on clinical and radiographic findings
• Presence of a second mesiobuccal (MB2) canal in the maxillary first molar
• Absence of preoperative pain or symptoms
• Teeth with periapical lesions smaller than 5 mm in diameter
• Ability to comply with follow-up visits and effectively communicate during the treatment process

You may not qualify if:

• Presence of symptomatic apical periodontitis or acute apical abscess
• Need for retreatment of previously treated teeth
• 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
• Inability to understand or follow the study instructions

Sponsors & Collaborators

• Mehmet Adıgüzel: lead

Study Sites (1)

Hatay Mustafa Kemal University Faculty of Dentistry

Antakya, Hatay, 31006, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor evaluating VAS scores and clinical data was blinded to the instrumentation groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Four parallel arms comparing single-, two-, three-, and four-file rotary systems in maxillary molar canals

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: July 29, 2025
• Primary Completion: March 19, 2026
• Study Completion: March 19, 2026
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available starting 6 months after study completion (May 19, 2026) and will remain available for 5 years (until May 19, 2031).
• Access Criteria: Access will be granted to qualified researchers upon reasonable request. Applicants must submit a proposal outlining the research objectives and intended data use. Data will be shared via secure electronic transfer after approval by the principal investigator. Use is restricted to academic and non-commercial research purposes only.

Locations

TU (1)