Dental Pulp NecrosisNCT06309095
Investigation of the Effect of Low Torque and Speed on Post-Operative Pain After Root Canal Treatment
A study testing use of VDW Silver Endodontic motor in people with Dental Pulp Necrosis, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Root canal preparation is one of the most important stages in root canal treatment. Nowadays, the use of Nickel-Titanium(Ni-Ti) rotary instrument systems for root canal expansion is becoming very popular. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Necrosis
- What is being tested?
- use of VDW Silver Endodontic motor
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 15 Apr 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients without a history of intolerance to nonsteroidal anti-inflammatory drugs
- Patients who have no physical or psychological disabilities and are competent in understanding and applying treatment protocols
- Mandibular first molars without preoperative pain,
- The relevant tooth is devital (non-living)
- Teeth that have not had root canal treatment before,
- Teeth that have not been traumatized and have no serious dental malposition,
Show all 9Show fewer
- Teeth that do not have complex root canal morphology,
- Patients whose root curvature is not >25°,
- Patients without sinus tract, periapical abscess and cellulitis,
Who cannot join
- Pregnancy and patients who may be pregnant
- Patients who have used cortisone in the last 6 months and analgesic-anti-inflammatory-antibiotic use in the last week
- The patient is allergic to one or more of the agents to be used during the procedure.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Science University
Afyonkarahisar, 03030
Ahmet D Uygun, Assoc. Prof., +905057513705, ademirhan100@hotmail.com
Betül Karaağaç, R.A., +905347934602, karaagacbetull@gmail.com
About this study
Official title: Investigation of the Effect of Low Torque and Speed on Post-Operative Pain After Root Canal Treatment: A Randomized Clinical Study
Root canal preparation is one of the most important stages in root canal treatment. Nowadays, the use of Nickel-Titanium(Ni-Ti) rotary instrument systems for root canal expansion is becoming very popular. The force required to rotate the Ni-Ti file is defined as the torque force and is considered a parameter for the stress produced within the canal. Ni-Ti rotary instruments can be used with a wide speed scale between 150 rpm (rotary per minute) and 40,000 rpm in conventional endodontic engines.
Low torque and speed values mean low pressure applied by the instruments in the root canal. With low forces and vibrations, motor noise is generally negligible, and the instruments can easily shape most root canals in a reasonable amount of time and with minimal mechanical stress (in medium-easy canals). The use of lower torque values has been shown to reduce cyclic fatigue of Ni-Ti rotary tools. With reduced cyclic fatigue, the risk of instrument breakage in complex root canal morphologies is minimized and complications that may occur during root canal treatment are reduced. However, with low torque and speed values, cutting efficiency decreases and the process time increases as the instrument advances in the canal and during possible treatment. Decreasing cutting efficiency may also result in the operator applying force to move through the canal. With the applied force, the friction resistance within the canal increases and the heat produced increases. For this reason, it is thought that the risk of post-operative pain may increase during or after the procedure.
The aim of this study is to investigate the incidence of post-operative pain and procedure time using the visual analog scale (VAS) among groups where low torque and speed values were applied during the use of the Ni-Ti rotary instrument system.
Read the detailed description
Patients with an indication for root canal treatment of the mandibular first molar tooth, who applied to Faculty of Health Sciences, Department of Endodontics, were selected. Patients aged between 18 and 65, who volunteered for the study and had no systemic disease and no preoperative pain, were included.
Patients meeting the inclusion criteria will be randomly divided into four groups (n=20) using a website (www.randomizer.org). The patient number and the randomized group from which the patient was selected will be recorded. All patients will be subjected to local anesthesia with articaine hydrochloride (Maxicaine, Istanbul) containing 1:100,000 adrenaline. After the entrance cavities of the teeth are opened with an aerator under water cooling, a rubber dam will be applied to the relevant teeth for isolation from the oral environment. After the entrance cavity is opened, the working length of the canals will be determined with the help of a No. 10 K-file (Dentsply Maillefer, Ballaigues, Switzerland) canal file and an electronic apex finder (Woodpex III, Woodpecker Medical Instrument Co, Guilin, China). In both groups, it was planned to use the NiTi rotary instrument system using V Taper Gold (Fanta Dental Material, Shanghai, China) files with the help of VDW.Silver endomotor (VDW, München, Germany). The patient groups were determined as the first group was 2N torque value and 350 rpm speed, the second group was 2N torque and 250 rpm speed, the third group was 1N torque and 350 rpm speed, and the fourth group was 1N torque and 250 rpm speed. The torque values to be applied are lower than the values recommended by the manufacturer and there is no harm in applying them in the literature. For irrigation of root canals, 2ml of 2.5% sodium hypochlorite will be used at each instrument change. For final irrigation, 17% EDTA( ethylenediaminetetraacetic acid) solution will be used. Root canals will be dried using sterile paper points. The root canals will be filled using gutta percha and a resin-containing root canal sealer (Dentsply Maillefer, Ballaigues, Switzerland) and the treatment will be completed by making the upper restoration. After the treatment, patients were given a VAS scale (Visual Analog Scale) and were instructed how to fill in their pain levels verbally and visually, 6, 12, 48, 72 hours and 1 week later. With the VAS scale, patients will be asked to note whether they use the prescribed Ibuprofen analgesic and the frequency of use. When patients come to their follow-up appointment, the forms will be taken from the patients and their post-treatment pain values will be compared. The collected data will be analyzed statistically with one-way ANOVA and post hoc Tukey tests.
- Conditions
- Dental Pulp Necrosis
- Being tested
- use of VDW Silver Endodontic motor
- Keywords
- Devital tooth
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of VDW Silver Endodontic motorDevice
All patients will be subjected to local anesthesia with articaine hydrochloride (Maxicaine, Istanbul) containing 1:100,000 adrenaline. After the entrance cavities of the teeth are opened, a rubber dam will be applied to the relevant teeth for isolation from the oral environment. After the entrance cavity is opened, the working length of the canals will be determined with the help of a No. 10 K-file (Dentsply Maillefer, Ballaigues, Switzerland) canal file and an electronic apex finder (Woodpex III, Woodpecker Medical Instrument Co, Guilin, China). In both groups, it was planned to use the NiTi rotary instrument system using V Taper Gold (Fanta Dental Material, Shanghai, China) files with the help of VDW.Silver endomotor (VDW, München, Germany). The endodontic motor will be used to adjust different speed and torque values during root canal treatment. Post-operative pain caused by different speed and torque values will be compared.
| Study group | Role | What they receive |
|---|---|---|
| 1 N (Newton) torque, 250 rpm(rotary per minute) speed | Experimental | The values specified in the endomotor will be used during root canal treatment. 1 N torque, 250 rpm speed Receives: Device: use of VDW Silver Endodontic motor |
| 1 N torque, 350 rpm speed | Experimental | The values specified in the endomotor will be used during root canal treatment. 1 N torque, 350 rpm speed Receives: Device: use of VDW Silver Endodontic motor |
| 2 N torque, 250 rpm speed | Experimental | The values specified in the endomotor will be used during root canal treatment. 2 N torque, 250 rpm speed Receives: Device: use of VDW Silver Endodontic motor |
| 2 N torque, 350 rpm speed | Experimental | The values specified in the endomotor will be used during root canal treatment. 2 N torque, 350 rpm speed Receives: Device: use of VDW Silver Endodontic motor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
The patient was asked to mark the severity of his or her pain with active motion on a horizontal line 100 mm in lenght. The intensity of the pain was calculated by measuring the area in which the individual marked between 0 (no pain) and 10 (the most severe pain I felt my life)
Measured: through study completion, an average of 1 month
Secondary outcomes (1)
Preparation time
While shaping the root canals at the specified values, the working time (second) will be measured with the help of a stopwatch.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completion15 Mar 2024 (estimated)
- Study completion15 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Pulp NecrosisStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Demirhan Uygun, Afyonkarahisar Health Sciences University
- Investigators
- Ahmet D Uygun, Assoc. Prof., Study chair, Afyonkarahisar Health Science University/ Dentistry Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309095
- Sponsor's protocol ID
- AFSU_AhmetDemirhanUygun_001
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karaagac B, Uygun AD. Investigation of the effect of low torque and speed values on postoperative pain after root canal treatment: a randomised clinical trial. BMC Oral Health. 2025 Oct 8;25(1):1554. doi: 10.1186/s12903-025-06989-x.
PubMed 41063114
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Low Torque and Speed on Post-Operative Pain After Root Canal Treatment: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06309095
- Acronym / sponsor ID
- AFSU_AhmetDemirhanUygun_001
- Conditions
- Dental Pulp Necrosis
- Keywords
- Devital tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 13 Mar 2024 (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.
Root canal preparation is one of the most important stages in root canal treatment. Nowadays, the use of Nickel-Titanium(Ni-Ti) rotary instrument systems for root canal expansion is becoming very popular. The force required to rotate the Ni-Ti file is defined as the torque force and is considered a parameter for the stress produced within the canal. Ni-Ti rotary instruments can be used with a wide speed scale between 150 rpm (rotary per minute) and 40,000 rpm in conventional endodontic engines.
Low torque and speed values mean low pressure applied by the instruments in the root canal. With low forces and vibrations, motor noise is generally negligible, and the instruments can easily shape most root canals in a reasonable amount of time and with minimal mechanical stress (in medium-easy canals). The use of lower torque values has been shown to reduce cyclic fatigue of Ni-Ti rotary tools. With reduced cyclic fatigue, the risk of instrument breakage in complex root canal morphologies is minimized and complications that may occur during root canal treatment are reduced. However, with low torque and speed values, cutting efficiency decreases and the process time increases as the instrument advances in the canal and during possible treatment. Decreasing cutting efficiency may also result in the operator applying force to move through the canal. With the applied force, the friction resistance within the canal increases and the heat produced increases. For this reason, it is thought that the risk of post-operative pain may increase during or after the procedure.
The aim of this study is to investigate the incidence of post-operative pain and procedure time using the visual analog scale (VAS) among groups where low torque and speed values were applied during the use of the Ni-Ti rotary instrument system.
Detailed description
Patients with an indication for root canal treatment of the mandibular first molar tooth, who applied to Faculty of Health Sciences, Department of Endodontics, were selected. Patients aged between 18 and 65, who volunteered for the study and had no systemic disease and no preoperative pain, were included.
Patients meeting the inclusion criteria will be randomly divided into four groups (n=20) using a website (www.randomizer.org). The patient number and the randomized group from which the patient was selected will be recorded. All patients will be subjected to local anesthesia with articaine hydrochloride (Maxicaine, Istanbul) containing 1:100,000 adrenaline. After the entrance cavities of the teeth are opened with an aerator under water cooling, a rubber dam will be applied to the relevant teeth for isolation from the oral environment. After the entrance cavity is opened, the working length of the canals will be determined with the help of a No. 10 K-file (Dentsply Maillefer, Ballaigues, Switzerland) canal file and an electronic apex finder (Woodpex III, Woodpecker Medical Instrument Co, Guilin, China). In both groups, it was planned to use the NiTi rotary instrument system using V Taper Gold (Fanta Dental Material, Shanghai, China) files with the help of VDW.Silver endomotor (VDW, München, Germany). The patient groups were determined as the first group was 2N torque value and 350 rpm speed, the second group was 2N torque and 250 rpm speed, the third group was 1N torque and 350 rpm speed, and the fourth group was 1N torque and 250 rpm speed. The torque values to be applied are lower than the values recommended by the manufacturer and there is no harm in applying them in the literature. For irrigation of root canals, 2ml of 2.5% sodium hypochlorite will be used at each instrument change. For final irrigation, 17% EDTA( ethylenediaminetetraacetic acid) solution will be used. Root canals will be dried using sterile paper points. The root canals will be filled using gutta percha and a resin-containing root canal sealer (Dentsply Maillefer, Ballaigues, Switzerland) and the treatment will be completed by making the upper restoration. After the treatment, patients were given a VAS scale (Visual Analog Scale) and were instructed how to fill in their pain levels verbally and visually, 6, 12, 48, 72 hours and 1 week later. With the VAS scale, patients will be asked to note whether they use the prescribed Ibuprofen analgesic and the frequency of use. When patients come to their follow-up appointment, the forms will be taken from the patients and their post-treatment pain values will be compared. The collected data will be analyzed statistically with one-way ANOVA and post hoc Tukey tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 N (Newton) torque, 250 rpm(rotary per minute) speed | Experimental | Device: use of VDW Silver Endodontic motorThe values specified in the endomotor will be used during root canal treatment. 1 N torque, 250 rpm speed |
| 1 N torque, 350 rpm speed | Experimental | Device: use of VDW Silver Endodontic motorThe values specified in the endomotor will be used during root canal treatment. 1 N torque, 350 rpm speed |
| 2 N torque, 250 rpm speed | Experimental | Device: use of VDW Silver Endodontic motorThe values specified in the endomotor will be used during root canal treatment. 2 N torque, 250 rpm speed |
| 2 N torque, 350 rpm speed | Experimental | Device: use of VDW Silver Endodontic motorThe values specified in the endomotor will be used during root canal treatment. 2 N torque, 350 rpm speed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients without a history of intolerance to nonsteroidal anti-inflammatory drugs
- Patients who have no physical or psychological disabilities and are competent in understanding and applying treatment protocols
- Mandibular first molars without preoperative pain,
- The relevant tooth is devital (non-living)
- Teeth that have not had root canal treatment before,
Key exclusion criteria (3 listed)
- Pregnancy and patients who may be pregnant
- Patients who have used cortisone in the last 6 months and analgesic-anti-inflammatory-antibiotic use in the last week
- The patient is allergic to one or more of the agents to be used during the procedure.
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 |
|---|---|---|
| use of VDW Silver Endodontic motorAll patients will be subjected to local anesthesia with articaine hydrochloride (Maxicaine, Istanbul) containing 1:100,000 adrenaline. After the entrance cavities of the teeth are opened, a rubber dam will be applied to the relevant teeth for isolation from the oral environment. After the entrance cavity is opened, the working length of the canals will be determined with the help of a No. 10 K-file (Dentsply Maillefer, Ballaigues, Switzerland) canal file and an electronic apex finder (Woodpex III, Woodpecker Medical Instrument Co, Guilin, China). In both groups, it was planned to use the NiTi rotary instrument system using V Taper Gold (Fanta Dental Material, Shanghai, China) files with the help of VDW.Silver endomotor (VDW, München, Germany). The endodontic motor will be used to adjust different speed and torque values during root canal treatment. Post-operative pain caused by different speed and torque values will be compared. | Device | 1 N (Newton) torque, 250 rpm(rotary per minute) speed, 1 N torque, 350 rpm speed, 2 N torque, 250 rpm speed, 2 N torque, 350 rpm speed |
Primary outcome
Visual analog scale
Time frame: through study completion, an average of 1 month
The patient was asked to mark the severity of his or her pain with active motion on a horizontal line 100 mm in lenght. The intensity of the pain was calculated by measuring the area in which the individual marked between 0 (no pain) and 10 (the most severe pain I felt my life)
1 secondary outcome
Preparation time
Time frame: through study completion, an average of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 41063114Karaagac B, Uygun AD. Investigation of the effect of low torque and speed values on postoperative pain after root canal treatment: a randomised clinical trial. BMC Oral Health. 2025 Oct 8;25(1):1554. doi: 10.1186/s12903-025-06989-x.
- Individual participant dataSharing planned: No
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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.
Ahmet D Uygun, Assoc. Prof. study chair
Afyonkarahisar Health Science University/ Dentistry Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of VDW Silver Endodontic motor in people with Dental Pulp Necrosis, run by Afyonkarahisar Health Sciences University 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 9 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmet D Uygun, Assoc. Prof. (+905057513705, ademirhan100@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06309095, which also lists 1 linked publication.
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 13 Mar 2024.