Assessment of Masseter Muscle With Ultrasonography

NCT06734559 | Active Not Recruiting

• 1 other identifier: HRÜ-DHF-END-NC-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

In teeth that remain decayed for a long time, the muscles in that area atrophy because the patient cannot use the decayed area much. As a result, muscle length and mass decrease. To compare the amount of this reduction before and after treatment with ultrasound and to treat accordingly

Conditions

Acute Apical Periodontitis of Pulpal Origin

Keywords

pain; masseter; muscle; ultrasonography; teeth

Outcome Measures

Primary Outcomes (2)

• The thickness and length of the masseter muscle

  Masseter muscle thickness measurements will made on the screen at the same time, with the help of the distance measurement feature of the USG device, over images of the muscles at rest and maximum contraction. masseter muscle thickness will be measured in millimeters (mm).

  first week

• Masseter muscle stiffness

  Masseter muscle stiffness will be measured in kilopascals (Kpa)

  first week

Secondary Outcomes (2)

• The thickness and length of the masseter muscle

  four weeks

• Masseter muscle stiffness

  four weeks

Study Arms (2)

ultrasound group

ACTIVE COMPARATOR

Apical periodontitis' is a general term used to describe the periapical inflammatory process that occurs in response to the presence of micro-organisms and other irritants within the root canal system of a tooth. The length and mass of the masseter muscle will be measured on the first and 28th day of root canal treatment in patients with acute apical periodontitis..

Diagnostic Test: Patients who have not antibiotic treatment for acute apical periodontitis in the last month and have not taken any anti-inflammatory medication in the past 24 hours.

sham group

SHAM COMPARATOR

Masseter muscle thickness and length in healthy individuals will be measured on days 1 and 28.

Other: patients who have not acute apical periodontitis

Interventions

patients who have not acute apical periodontitis OTHER

Masseter measurements will be made from day 1 to day 28 in healthy subjects without acute apical periodontitis.

sham group

Patients who have not antibiotic treatment for acute apical periodontitis in the last month and have not taken any anti-inflammatory medication in the past 24 hours. DIAGNOSTIC_TEST

Patients with acute apical periodontitis will first have masseter muscle measurements in the relevant area and then the decayed tooth will be treated with calcium hydroxide for 14 days. Then the dressing will be applied with calcium hydroxide again. At the end of 28 days, the patient will be measured again by ultrasonography and the initial and final data will be compared.

ultrasound group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy adults aged 18-65 years (American Society of Anesthesiologists Class I) Diagnosis of acute apical periodontitis Presence of at least four posterior occlusal units (one premolar pair counted as one unit; one molar pair counted as two units) Age ≥18 years Absence of maxillofacial pathology or systemic disease No history of temporomandibular joint or masticatory muscle disorders No complaints of dysphoni No diagnosed muscular disorders

You may not qualify if:

• Presence of systemic disease Current use of any medication Fewer than 20 natural teeth Presence of prosthetic restorations (single crowns, fixed dental prostheses, or removable prostheses) Dental implant restorations History of periodontal treatment within the previous year Diagnosis of symptomatic pulpitis Pregnancy Smoking Unilateral edentulism

Sponsors & Collaborators

• Harran University: lead

Study Sites (2)

Harran University

Sanliurfa, Haliliye, 63300, Turkey (Türkiye)

Location

Nezif Çelik

Karaköprü, Şanlıurfa, 63300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• nezif çelik, PhD

  HARRAN UNİVERSTY DENTİSTRY FACULTY

  STUDY DIRECTOR

• mehmet EMİN DOĞAN, PhD

  HARRAN UNİVERSTY DENTİSTRY FACULTY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: two groups with control

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 16, 2024
• Study Start: January 30, 2025
• Primary Completion: November 1, 2025
• Study Completion: March 11, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)