Effect of Rotary File Number on MB2 Canal Negotiation and Postoperative Pain
NCT ID: NCT07091981
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
152 participants
INTERVENTIONAL
2025-06-18
2025-09-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Single-file rotary instrumentation (One Curve)
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.
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.
Two-file rotary instrumentation (Perfect Minimally Invasive)
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.
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.
Three-file rotary instrumentation (VDW Rotate)
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.
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.
Four-file rotary instrumentation (Perfect Advanced Kit)
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.
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
65 Years
ALL
No
Sponsors
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Mehmet Adıgüzel
OTHER
Responsible Party
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Mehmet Adıgüzel
Associate Professor
Locations
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Hatay Mustafa Kemal University Faculty of Dentistry
Antakya, Hatay, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025/M08-D38
Identifier Type: OTHER
Identifier Source: secondary_id
HMKU-MB2Pain-RCT2025
Identifier Type: -
Identifier Source: org_study_id
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