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临床试验/NCT06734559
NCT06734559进行中(未招募)不适用

Evaluation of the Effect of Acute Apical Periodontitis on Masseter Muscle With Elastography: A Case-control Study

Harran University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
2
主要终点
The thickness and length of the masseter muscle

研究概览

简要总结

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

详细描述

Material and method Clinical examination Apical periodontitis is inflammation of the periodontium at the entry portals of the root canal system. Typically, the lesion is found at the root apex, but it can occur at various levels along the root surface, and lesions can also develop in the lateral and furcal regions Acute apical periodontitis (AAP) is characterized by acute clinical symptoms (pain with the teeth in occlusion, tenderness to percussion or palpation in the periapical region, intrasulcular/intracanal pus drainage and swelling) but no evidence of periapical radiolucency except for mild widening of the periodontal ligament.

Patients will be selected from patients who apply to the Department of Endodontics, Faculty of Dentistry, Harran University, as a result of clinical and radiological examinations for acute apical periodontitis cases. After the patients are informed about the treatments to be performed, ultrasound measurements will be performed on the patients. Ultrasound(USG) imaging procedures will be performed by a single operator. Data will be recorded. Then, under local anesthesia and rubber dam isolation, the relevant tooth will be opened with round (Intensiv212) access cavities. Working length (WL) was determined using an electronic apex locator (Root ZX II; J. Morita Corp., Kyoto, Japan) in combination with a size 10 K-file. ProTaper Next X1 (#17, 0.04 taper) and X2 (#25, 0.06 taper) files (Dentsply Sirona, Ballaigues, Switzerland) were used sequentially with an endodontic motor (VDW Silver Reciproc; VDW, Munich, Germany) using gentle in-and-out movements in accordance with the manufacturer's instructions. The canals will be irrigated with 2 ml sodium hypochlorite at each file change. final irrigation will be done with 5ml 17% EDTA (Ethylenediaminetetraacetic acid), 2.5ml DW (distilled water) and 5.25% NaOCl (sodium hypochlorite). Then, after the canals are dried, they will be filled with calcium hydroxide and kept for 14 days with glass ionomer filling. At the end of this period, the patients will be called back, the necessary checks will be done, the canals will be washed again and kept for another 14 days with calcium hydroxide. At the end of the total of 28 days, the measurements will be repeated with a second ultrasound from the patients whose symptoms have completely disappeared and before and after comparisons will be made.

USG imaging In USG evaluation, LOGIQ P9 XDclear (GE HealthCare, USA) Masseter muscle thickness measurements will assume that the part with the highest repeatability is the middle part of the mediolateral line along the mandibular ramus. Therefore, when making measurements, the "L 3-12 RS (3-12 MHz)" linear probe will be placed approximately from the region corresponding to the middle of the mediolateral line along the mandibular ramus, perpendicular to the fibers of the masseter muscle, and parallel to the long axis of the corpus mandibula, in the middle between the zygomatic arch and the gonial angle, close to the occlusal plane, which is the thickest part of the masseter muscle.

Muscle thickness was defined as the maximum distance between the inner and outer fascia. Shear wave elastography (SWE) method will be used in ultrasonographic elastography examinations of muscles. In this study, the value recorded as Young's modulus will be defined as hardness and kPa units will be used.

Masseter Muscle SWE Examination For each participant, the stiffness values of the muscles at rest and at maximum contraction will be calculated for the right and left masseter muscles. The probe will be placed at the widest part in the middle of the muscle belly, perpendicular to the long axis of the masseter muscle. In the second method, the probe will be placed at the widest part in the middle of the muscle, parallel to the long axis of the masseter muscle.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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..

干预措施: 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)

sham group

Sham Comparator

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

干预措施: patients who have not acute apical periodontitis (Other)

结局指标

主要结局

The thickness and length of the masseter muscle

时间窗: first week

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).

Masseter muscle stiffness

时间窗: first week

Masseter muscle stiffness will be measured in kilopascals (Kpa)

次要结局

  • The thickness and length of the masseter muscle(four weeks)
  • Masseter muscle stiffness(four weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nezif Celik

assistant professor

Harran University

研究点 (2)

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