Postoperative PainMB2-PAINNCT07091981
Effect of Rotary File Number on MB2 Canal Negotiation and Postoperative Pain
A study testing One Curve Rotary File, Perfect Super System Minimal Invasive Kit and VDW Rotate in people with Postoperative Pain and Asymptomatic Apical Periodontitis, run by Mehmet Adıgüzel at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Postoperative Pain, Asymptomatic Apical Periodontitis
- What is being tested?
- One Curve Rotary File, Perfect Super System Minimal Invasive Kit and VDW Rotate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jul 2025to 19 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatay Mustafa Kemal University Faculty of Dentistry
Antakya, Hatay, 31006
About this study
Official title: Effect of Number of Rotary Instruments on Negotiating Second Mesiobuccal Canals to Working Length and on Postoperative Pain: A Randomized Clinical Trial
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.
- Being tested
- One Curve Rotary File, Perfect Super System Minimal Invasive Kit, VDW Rotate, Perfect Super System Advanced Kit
- Keywords
- VAS Pain Scale, Endodontic Treatment, Rotary Files
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Curve Rotary FileDevice
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.
Perfect Super System Minimal Invasive KitDevice
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.
VDW RotateDevice
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.
Perfect Super System Advanced KitDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Perfect Super System Advanced Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Daily assessment for 7 consecutive days following treatment (Days 1-7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start29 Jul 2025
- Primary completion19 Mar 2026
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four parallel arms comparing single-, two-, three-, and four-file rotary systems in maxillary molar canals
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Adıgüzel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehmet Adıgüzel, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091981
- Sponsor's protocol ID
- HMKU-MB2Pain-RCT2025
- Other IDs
- 2025/M08-D38
- Acronym
- MB2-PAIN
- Status last verified
- Sep 2026
- First submitted
- 21 Jul 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Number of Rotary Instruments on Negotiating Second Mesiobuccal Canals to Working Length and on Postoperative Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07091981
- Acronym / sponsor ID
- MB2-PAIN / HMKU-MB2Pain-RCT2025
- Keywords
- VAS Pain Scale, Endodontic Treatment, Rotary Files
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Mehmet AdıgüzelUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 19 Mar 2026 (actual)
- Study completion
- 19 Mar 2026 (actual)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Four parallel arms comparing single-, two-, three-, and four-file rotary systems in maxillary molar canals
| Arm | Type | Receives |
|---|---|---|
| Single-file rotary instrumentation (One Curve) | Experimental | Device: One Curve Rotary FileRoot 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. |
| Two-file rotary instrumentation (Perfect Super System Minimal Invasive) | Experimental | Device: Perfect Super System Minimal Invasive KitRoot 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. |
| Three-file rotary instrumentation (VDW Rotate) | Experimental | Device: VDW RotateRoot 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. |
| Four-file rotary instrumentation (Perfect Super System Advanced Kit) | Experimental | Device: Perfect Super System Advanced KitRoot 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One Curve Rotary FileA 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. | Device | Single-file rotary instrumentation (One Curve) |
| Perfect Super System Minimal Invasive KitA 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. | Device | Two-file rotary instrumentation (Perfect Super System Minimal Invasive) |
| VDW RotateA 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. | Device | Three-file rotary instrumentation (VDW Rotate) |
| Perfect Super System Advanced KitA 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. | Device | Four-file rotary instrumentation (Perfect Super System Advanced Kit) |
Primary outcome
Postoperative Pain Intensity (VAS Score)
Time frame: 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."
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One Curve Rotary File, Perfect Super System Minimal Invasive Kit and VDW Rotate in people with Postoperative Pain and Asymptomatic Apical Periodontitis, run by Mehmet Adıgüzel at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (VAS Score) (time frame: Daily assessment for 7 consecutive days following treatment (Days 1-7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.