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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07091981
Acronym
MB2-PAIN
Enrollment
168
Registered
2025-07-29
Start date
2025-07-29
Completion date
2026-03-19
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic Apical Periodontitis, Postoperative Pain

Keywords

VAS Pain Scale, Endodontic Treatment, Rotary Files

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.

Interventions

DEVICEOne Curve Rotary File

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.

DEVICEPerfect Super System Minimal Invasive Kit

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.

DEVICEVDW Rotate

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.

DEVICEPerfect Super System Advanced Kit

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.

Sponsors

Mehmet Adıgüzel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcome assessor evaluating VAS scores and clinical data was blinded to the instrumentation groups.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain Intensity (VAS Score)Daily assessment for 7 consecutive days following treatment (Days 1-7)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."

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026