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Not yet recruitingNCT06309095Updated Mar 13, 2024

Investigation of the Effect of Low Torque and Speed on Post-Operative Pain After Root Canal Treatment

An interventional study of use of VDW Silver Endodontic motor in Dental Pulp Necrosis, sponsored by Afyonkarahisar Health Sciences University. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-13.

Sponsored by Afyonkarahisar Health Sciences University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Dental Pulp Necrosis with a site in Turkey — 3 open to participants now, 5 under way, none of them phase 3. Dental Pulp Necrosis · Turkey.

Planned enrollment
6th of 15
80 · median 64
Started
2024
with 7 others
No phase
14 of 20
3 open now
Registered
6th of 20
by date
Lead sponsor
1 of 20
Afyonkarahisar Health Sciences University

Among the 20 studies in Dental Pulp Necrosis with a site in Turkey, this one is the 6th largest by planned enrollment of the 15 interventional ones that give a count, is one of 8 that started in 2024, is one of 14 with no phase, and was the 6th registered.

Dental Pulp Necrosis

157 studies on the registry are indexed under Dental Pulp Necrosis; 44 are open to participants now.

Browse Dental Pulp Necrosis studies →

Open to participants now

3 of the 20 studies in Dental Pulp Necrosis with a site in Turkey are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 15 Dental Pulp Necrosis studies recruiting now, 6 (40%) set no upper age limit and 7 (47%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study 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. 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.

03

Conditions studied

  • Dental Pulp Necrosis

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Keywords

  • Devital tooth
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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,
  • Teeth that do not have complex root canal morphology,
  • Patients whose root curvature is not >25°,
  • Patients without sinus tract, periapical abscess and cellulitis,

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    1 N (Newton) torque, 250 rpm(rotary per minute) speed

    The values specified in the endomotor will be used during root canal treatment. 1 N torque, 250 rpm speed

    Device: use of VDW Silver Endodontic motor

  • Experimental
    1 N torque, 350 rpm speed

    The values specified in the endomotor will be used during root canal treatment. 1 N torque, 350 rpm speed

    Device: use of VDW Silver Endodontic motor

  • Experimental
    2 N torque, 250 rpm speed

    The values specified in the endomotor will be used during root canal treatment. 2 N torque, 250 rpm speed

    Device: use of VDW Silver Endodontic motor

  • Experimental
    2 N torque, 350 rpm speed

    The values specified in the endomotor will be used during root canal treatment. 2 N torque, 350 rpm speed

    Device: use of VDW Silver Endodontic motor

Interventions

  • Deviceuse of VDW Silver Endodontic motor

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 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.

    Time frame: through study completion, an average of 1 month

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2024; primary completion for Mar 2024, 0 months later.

Of 66 non-industry interventional studies with no phase under Dental Pulp Necrosis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 0 months is below that.

Counting every sponsor, half of 67 studies reached it within 15 months; a quarter within 9 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 21, 2024
First posted
Mar 13, 2024
StartEst.
Mar 15, 2024
Primary completionEst.
Mar 15, 2024
CompletionEst.
Apr 15, 2024
Last update
Mar 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06309095
Responsible party
Ahmet Demirhan Uygun (Associate Professor, Afyonkarahisar Health Sciences University) — Principal investigator
First posted
Mar 13, 2024
Start date
Mar 15, 2024 (estimated)
Primary completion
Mar 15, 2024 (estimated)
Completion
Apr 15, 2024 (estimated)
Last update
Mar 13, 2024

Study contacts

Ahmet D Uygun, Assoc. Prof.
Contact
ademirhan100@hotmail.com
+905057513705
Betül Karaağaç, R. A.
Contact
karaagacbetull@gmail.com
+905347934602
Ahmet D Uygun, Assoc. Prof.
study chair · Afyonkarahisar Health Science University/ Dentistry Faculty

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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