NCT06853028

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

February 14, 2025

Last Update Submit

February 28, 2025

Conditions

Keywords

root canal treatmentultrasonographyendodontic painacute apical periodontitismasticatory laterality

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

Other: ultrasound measurement

Interventions

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

Patients with a masticatory laterality due to acute apical periodontitis

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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

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)

Location

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: 35028733BACKGROUND
  • Jeon 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: 28861285BACKGROUND
  • Daline 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: 37021602BACKGROUND
  • Gurler 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.

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

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

Locations