The Role of Root Canal Treatment in Alleviating Endodontic Pain-Induced Asymmetry and Restoring Muscle Balance

February 28, 2025 updated by: Kübra Gürler, Cukurova University

The Role of Root Canal Treatment in Alleviating Endodontic Pain-Induced Asymmetry and Restoring Muscle Balance: a Prospective Cohort Study

The study hypothesizes that masticatory laterality caused by acute apical periodontitis pain result in muscle asymmetry. Furthermore, it posits that successful root canal treatment, by restoring normal bilateral chewing function, will reduce this asymmetry, as evidenced by ultrasonographic measurements of the masseter and anterior temporal muscles.The main question it aims to answer is:

Can bilateral chewing function be restored after root canal treatment procedures in patients with masticatory laterality due to painful teeth due to acute apical periodontitis?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey, 01250
        • Çukurova Üniversitesi Diş Hekimliği Fakültesi, Gültepe, Sarıçam/Adana/Türkiye

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

•. 20 systemically healthy patients (11 female, 9 male) aged 18-60 years

  • Patients with masticatory laterality due to tooth pain for at least 30 days
  • First and second maxillary or mandibular molars with acute apical periodontitis due to deep caries
  • Teeth with moderate or severe pain according to the VAS (no pain (0 mm), mild pain (1-3 mm), moderate pain (4-6 mm), and severe pain (7-10 mm))
  • Teeth that responded positively to percussion test
  • Teeth without periapical pathosis

Description

Inclusion Criteria

  • Patients with masticatory laterality due to tooth pain for at least 30 days
  • First and second maxillary or mandibular molars with acute apical periodontitis due to deep caries
  • Teeth with moderate or severe pain according to the VAS (no pain (0 mm), mild pain (1-3 mm), moderate pain (4-6 mm), and severe pain (7-10 mm))
  • Teeth that responded positively to percussion test
  • Teeth without periapical pathosis were included in the study. Exclusion Criteria
  • Systemic conditions affecting muscle structure or function, such as neuromuscular or endocrine disorders.
  • Non-endodontic odontogenic pain.
  • Prior endodontic treatment of the relevant tooth within the last 30 days.
  • History of trauma or surgery to the head, face, or teeth within the last six months.
  • Severe communication disorders or psychological issues.
  • Inability to complete treatment in a single visit due to exudation or bleeding
  • Patients with masticatory laterality due to missing tooth on any side of the dental arch
  • Patients who have painful teeth in opposite sides of the dental arch
  • TMD patients were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with a masticatory laterality due to acute apical periodontitis
Other: ultrasound measurement
Muscle thickness measurements were performed with the ultrasound device immediately before root canal treatment, 1 week after, and 3 months after the treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasonography
Time Frame: immediately before root canal treatment, 1 week after and 3 months after the treatment

Ultrasound (also called sonography or ultrasonography) is a noninvasive imaging test. An ultrasound picture is called a sonogram. Ultrasound uses high-frequency sound waves to create real-time pictures or video of internal organs or other soft tissues, such as blood vessels. The masseter and anterior temporal muscle thicknesses of the patients were measured bilaterally using a high-frequency linear scanning probe (7 MHz) in B-mode of the Clarius Mobile Health ultrasound device (Vancouver, Canada). As no established formula exists to calculate muscle thickness asymmetry, the asymmetry index was based on another study in the literature.

Asymmetry Index = [(Control Side - Painful Side) / (Control Side + Painful Side)] × 100
immediately before root canal treatment, 1 week after and 3 months after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10.05.2024/144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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