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

NCT06309095 | Not Yet Recruiting

• 1 other identifier: AFSU_AhmetDemirhanUygun_001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Pulp Necrosis

Keywords

Devital tooth

Outcome Measures

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)

  through study completion, an average of 1 month

Secondary Outcomes (1)

• Preparation time

  through study completion, an average of 1 month

Study Arms (4)

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

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

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

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

Device: use of VDW Silver Endodontic motor

Interventions

use of VDW Silver Endodontic motor DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Science University

Afyonkarahisar, 03030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmet D Uygun, Assoc. Prof.

  Afyonkarahisar Health Science University/ Dentistry Faculty

  STUDY CHAIR

Central Study Contacts

Ahmet D Uygun, Assoc. Prof.

CONTACT

+905057513705; ademirhan100@hotmail.com

Betül Karaağaç, R. A.

CONTACT

+905347934602; karaagacbetull@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 13, 2024
• Study Start: March 15, 2024
• Primary Completion: March 15, 2024
• Study Completion: April 15, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)