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OpenTrials
Completed

NCT Number: NCT06853028

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

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?

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Çukurova Üniversitesi Diş Hekimliği Fakültesi, Gültepe, Sarıçam/Adana/Türkiye

Adana, 01250, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound measurement

Other

Muscle thickness measurements were performed with the ultrasound device immediately before root canal treatment, 1 week after, and 3 months after the treatment.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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