The Role of Root Canal Treatment in Alleviating Endodontic Pain-Induced Asymmetry and Restoring Muscle Balance
1 other identifier
observational
20
1 country
1
Brief Summary
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedFirst Submitted
Initial submission to the registry
February 14, 2025
CompletedFirst Posted
Study publicly available on registry
February 28, 2025
CompletedMarch 4, 2025
February 1, 2025
8 months
February 14, 2025
February 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ultrasonography
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
Study Arms (1)
Patients with a masticatory laterality due to acute apical periodontitis
Interventions
Muscle thickness measurements were performed with the ultrasound device immediately before root canal treatment, 1 week after, and 3 months after the treatment.
Eligibility Criteria
•. 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
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Çukurova Üniversitesi Diş Hekimliği Fakültesi, Gültepe, Sarıçam/Adana/Türkiye
Adana, 01250, Turkey (Türkiye)
Related Publications (4)
Elbarbary M, Sgro A, Khazaei S, Goldberg M, Tenenbaum HC, Azarpazhooh A. The applications of ultrasound, and ultrasonography in dentistry: a scoping review of the literature. Clin Oral Investig. 2022 Mar;26(3):2299-2316. doi: 10.1007/s00784-021-04340-6. Epub 2022 Jan 14.
PMID: 35028733BACKGROUNDJeon HM, Ahn YW, Jeong SH, Ok SM, Choi J, Lee JY, Joo JY, Kwon EY. Pattern analysis of patients with temporomandibular disorders resulting from unilateral mastication due to chronic periodontitis. J Periodontal Implant Sci. 2017 Aug;47(4):211-218. doi: 10.5051/jpis.2017.47.4.211. Epub 2017 Aug 21.
PMID: 28861285BACKGROUNDDaline IH, Slade GD, Fouad AF, Nixdorf DR, Tchivileva IE. Prevalence of painful temporomandibular disorders in endodontic patients with tooth pain. J Oral Rehabil. 2023 Jul;50(7):537-547. doi: 10.1111/joor.13457. Epub 2023 Apr 14.
PMID: 37021602BACKGROUNDGurler K, Guner Akgul I, Duyan Yuksel H, Sisli SN. The Role of Root Canal Treatment in Alleviating Endodontic Pain-Induced Asymmetry and Restoring Muscle Balance: A Self-Controlled Prospective Observational Study. Aust Endod J. 2025 Dec;51(3):650-659. doi: 10.1111/aej.12979. Epub 2025 Jul 29.
PMID: 40726276DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DDS MSc
Study Record Dates
First Submitted
February 14, 2025
First Posted
February 28, 2025
Study Start
September 1, 2023
Primary Completion
May 1, 2024
Study Completion
August 1, 2024
Last Updated
March 4, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share