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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings