Effect of Different Apical Actions on Local Inflammatory Mediators and Pain

NCT06760312 | Completed

• 1 other identifier: 2023-KAE-0080
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine patients' the inflammation and pain response to different apical actions used in rotary instrumentation during root canal shaping process. The main questions it aims to answer are:

1. 1.How the different apical actions of endodontic motors influence the pain and inflammatory mediator release from the periapical region of related tooth?
2. 2.Does the perceived pain differ among the used apical action methods after the root canal preparation?
3. 3.Are the perceived pain and local pain mediator levels coherent?

Conditions

Postoperative Dental Pain; Pulp Disease, Dental; Pulpitis - Irreversible

Keywords

apical kinematics; apical action; apical reverse; apical slow-down; continuous rotation; Substance P; postoperative pain; Inflammation

Outcome Measures

Primary Outcomes (1)

• Substance P

  The local Substance P amount will be assesed with ELISA kits

  From Day 0 to Day 3. The last measurement will be taken just before the end of the interventional treatment.

Secondary Outcomes (4)

• Visual Analog Scale

  From Day 0 to Day 3. The last measurement will be taken just before the end of the interventional treatment.

• Inflammatory Mediator: IL-1ß

  From Day 0 to Day 3. The last measurement will be taken just before the end of the interventional treatment.

• Inflammatory Mediator: IL-6

  From Day 0 to Day 3. The last measurement will be taken just before the end of the interventional treatment.

• Inflammatory Mediator: TNF alpha

  From Day 0 to Day 3. The last measurement will be taken just before the end of the interventional treatment.

Study Arms (3)

Continuous Rotation

EXPERIMENTAL

The apical root canal shaping mode of the apex locator integrated endodontic motor is "Continuous Rotation" which is the standard and mostly used option in endodontics. Works as a Control group also

Procedure: Root canal shaping with Continuous Rotation

Apical Reverse

EXPERIMENTAL

The apical root canal shaping mode of the apex locator integrated endodontic motor is "Reverse". The motor makes a reverse movement to prevent the file over the working length

Procedure: Root canal shaping with Apical Reverse

Apical Slow-down

EXPERIMENTAL

The apical root canal shaping mode of the apex locator integrated endodontic motor is "Apical Slow-down". The motor slows down the rotation to preserve the working length and apical constriction.

Procedure: Root canal shaping is conducted with Apical slow-down kinematic.

Interventions

Root canal shaping with Continuous Rotation PROCEDURE

The root canal shaping is conducted with a continuous rotation kinematic.

Continuous Rotation

Root canal shaping with Apical Reverse PROCEDURE

The root canal shaping is conducted with a apical reverse kinematic.

Apical Reverse

Root canal shaping is conducted with Apical slow-down kinematic. PROCEDURE

The root canal shaping is conducted with a apical slow-down kinematic.

Apical Slow-down

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Mild, moderate pulpitis and pulpal expose patients in need of root canal -treatment to their mandibular premolars.
• Healthy periodontal tissue with Periapical Index under 2.
• Helathy adjacent teeth.

You may not qualify if:

• Systemic diseases
• Percussion pain
• Patients who did not consent to a vital pulp therapy
• Radiologically seen open apex, root resorption, calcification
• Periodontal pocket beyond 4mm in length
• Consumption of Antibiotics or Corticosteroids 1 month before the treatment
• Consumption of antiinflammatory drugs 2 days before the treatment

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

İzmir Katip Çelebi Üniversitesi

Izmir, Çiğli, 35649, Turkey (Türkiye)

Location

Related Publications (1)

• Cohen, J (1988) Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Erlbaum

  BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases; Pain, Postoperative; Inflammation

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Emrah Karataşlıoğlu, PhD

  İzmir Katip Çelebi Üniversitesi

  STUDY CHAIR

• Mustafa Mert Tulgar, Dmd

  İzmir Katip Çelebi Üniversitesi

  PRINCIPAL INVESTIGATOR

• Yağmur Kılıç, Dmd

  İzmir Katip Çelebi Üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof. Dr.

Model Details: n=66 participants will be randomized into 3 different intervention groups.

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 6, 2025
• Study Start: February 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-06

Locations

TU (1)