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| ID | Type | Description | Link |
|---|---|---|---|
| 2025/M08-D38 | Other Identifier | Hatay Mustafa Kemal Univ EC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-file rotary instrumentation (One Curve) | Experimental | 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. |
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| Two-file rotary instrumentation (Perfect Minimally Invasive) | Experimental | 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. |
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| Three-file rotary instrumentation (VDW Rotate) | Experimental | 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. |
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| Four-file rotary instrumentation (Perfect Advanced Kit) | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mehmet A. Adıgüzel, DDS, PhD | Contact | +90 5447608920 | dt.mehmetadiguzel@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hatay Mustafa Kemal University Faculty of Dentistry | Recruiting | Antakya | Hatay | 31006 | Turkey (Türkiye) |
De-identified individual participant data (IPD) including pain scores (VAS values), demographic data (age, sex), treatment group allocation, and working length negotiation success will be shared.
IPD and supporting information will be available starting from 6 months after study completion (March 2026) and will remain available for 5 years (until March 2031).
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.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D003790 | Dental Pulp Necrosis |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Four parallel arms comparing single-, two-, three-, and four-file rotary systems in maxillary molar canals
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Participants were blinded to the number of rotary instruments used during the root canal procedure
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| 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. |
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| 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. |
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| 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. |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |