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Evaluation of Intra-articular Injection of Hyaluronic Acid Versus Radiofrequency Current in Management of Reduced TMJ Disc Displacement

2026년 9월 3일 업데이트: Alaa Kamal Abdelaal Mohamed, Al-Azhar University

Aim of Study The aim of this study was to compare between three modalities in treatment of TMJ internal derangement aiming for optimizing treatment of this condition.

Primary outcome: to evaluate clinical outcomes such as pain level, maximum mouth opening, and TMJ sounds.

Secondary outcome: to assess position of disc and disc recapture on radiographic film.

연구 개요

상세 설명

Introduction Temporomandibular disorders (TMD) are a heterogeneous group of musculoskeletal and neuromuscular conditions involving the temporomandibular joint complex, surrounding muscles and bony components. It is a chronic pain disorder with a prevalence as high as 38% of the general adult population. TMD show a female predilection (2.24:1) with peak incidence around 20 - 40 years of age.

Internal derangement of TMJ is a common orofacial problem that can cause significant pain and / or dysfunction. The clinical signs of the internal derangements are abnormal mandibular kinetics with or without the presence of TMJ noises and pain. The most common form of internal derangement is anterior disk displacement with reduction. Its manifestation, include; TMJ noises (clicking) or popping sounds when the disk slide as the jaw opens or closes. It may cause pain in the area of the TMJ which may radiate to the surrounding areas especially the ear. This pain may be severe enough to interfere with normal chewing and may cause anxiety and depression and even lowering the quality of life.

There have been many options for management of this condition as:

Pharmacotherapy (1- Non-steroidal anti-inflammatory drugs ,2- Antidepressants

,3- Imotun), Physical Therapy (1-Low level laser therapy, 2- Ultrasound and electrical stimulation), Splint Therapy as (occlusal splints), Hyaluronic acid injection, Muscle Injection with BTX , Arthrocentesis and Arthroscopy. Patients with this disorder tend to exhibit a reduction in intra-articular HA concentration so lubricant is reduced, HA provides a long-term lubricating, reducing inflammatory mediators action and increasing joint mobility (movement range). A study of two HA injections at weekly intervals is more effective than placebo injections of saline and joint catabolite levels decreased significantly with a supplemental HA injection.

HA forms a layer which not only covers but also penetrates the articular surfaces. It has been proven that HA plays a significant role in the nutrition and lubrication of the TMJ articular surfaces, When the intraarticular pressure reaches sub-atmospheric values, the proteins lose contact with the articular surfaces and the HA assumes a spheroidal conformation, allowing sliding movements within the TMJ, and when it exceeds atmospheric values HA occurs in the linear form and penetrates the fibrocartilage, which is necessary for TMJ nutrition. HA found to be responsible on stabilization of TMJ component Recently, Radiofrequency (RF) has been used as a supportive treatment in this condition. RF is an electromagnetic wave with radiation frequency between 3 Hz and 3 THz, it has low or minor reaction of the nerves to high frequency alternating current as it is a good thing and that is why RF became irreplaceable therapy in all medical fields especially in dentistry .RF beneficial effect is to restore function of the muscles by improving blood circulation and thus obtain an analgesic effect. It is noninvasive method, and it should be recommended in supportive treatment of temporomandibular disorders. Due to severity of the pain combined therapy may be used for synergistic effect. Therefore, this study is attempt to evaluate clinical and radiographic effect combine therapy in management of TMJ internal derangement.

연구 유형

중재적

등록 (실제)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Asyut Governorate
      • Asyut, Asyut Governorate, 이집트
        • Faculty of dental medicine , Al Azhar university

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Adult patients over 18 years of age.
  2. Patients were diagnosed with internal derangement of TMJ. (Anterior disc displacement with reduction)
  3. TMJ pain of non-odontogenic origin as confirmed by Research Diagnostic Criteria (RDC) for TMD/RDC axis II.
  4. Pain on chewing or maximal mouth opening with a duration of at least 3 months.
  5. Patients were accepted study condition and agree to attend to schedule follow up.

    -

Exclusion Criteria:

  1. Anterior disc displacement without reduction
  2. Trauma cases
  3. Polyarthritis as rheumatoid
  4. Cases that had contraindication to perform MRI scan.
  5. Cases that had contraindication to RF 1. Pregnancy 2. Presence of metal elements at area of therapy (plates and screws after osteosynthesis) 3. Tumors. 4. Skin diseases. 5. Open wounds. 6. Acute phase of thyroid diseases. 7. Muscular dystrophy. -

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: HA injection
The patients will be randomizedly divided into 3 groups. G1: will include 10 patient that will be treated by intra articular injection of 1 ml HA. After disinfecting the preauricular area with 10% povidone iodine solution, the needle insertion site will be marked on the skin 10 mm in front of the tragus and 2 mm below the canthal-tragus line. Articaine 1:100,000 epinephrine will be administered for local anesthesia, The patients will required to widely open their mouths to better define the empty glenoid fossa, and a 19 mm G needle will placed into the superior joint space using the landmark. Inside the superior joint compartment of the TMJ, a volume of 1 mL HA solution will be injected while the mouth is wide open.
HA injection
실험적: Radio-frequency
will include 10 patient that will be treated by 5 procedure of RF current, the application of radiation will be to the muscle area the energy will be 20 J, the frequency 3 MHz, bipolar technique, the duration of the procedure is 10 minutes, and the coupling substance is a gel for ultrasound examinations.
Procedure of RF current
실험적: HA injection + Radio-frequency (combination therapy )
Combination therapy
HA injection
Procedure of RF current

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Maximum Mouth Opening (MMO)
기간: Baseline, 1 week, 1 month, and 4 months after treatment.
The interincisal distance was measured which were the distance from incisal edge of maxillary central incisor to incisal edge of mandibular central incisor by a digital caliper.
Baseline, 1 week, 1 month, and 4 months after treatment.
TMJ sounds
기간: Baseline, 1 week, 1 month, and 4 months after treatment.
TMJ clicking was detected by a stethoscope if it was not audible during asking patient to open and close his mouth.
Baseline, 1 week, 1 month, and 4 months after treatment.
Pain intensity measured by (Visual Analog Scale)
기간: Baseline, 1 week, 1 month, and 4 months after treatment.
Pain intensity will be assessed using the (Visual Analog Scale) , with scores ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain, The minimum value is 0 and the maximum value is 10 , higher score mean a worse outcome.
Baseline, 1 week, 1 month, and 4 months after treatment.

2차 결과 측정

결과 측정
측정값 설명
기간
Radiographic
기간: Baseline and 4 months after treatment.
Magnetic resonance imaging (MRI) was captured to detect disc position and abnormalities of TMJ. MRI was obtained to confirm initial diagnosis of anterior disc displacement.
Baseline and 4 months after treatment.

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 4월 10일

기본 완료 (실제)

2024년 2월 10일

연구 완료 (실제)

2024년 2월 10일

연구 등록 날짜

최초 제출

2026년 8월 31일

QC 기준을 충족하는 최초 제출

2026년 8월 31일

처음 게시됨 (실제)

2026년 9월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 3일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • HA inject vs RF in TMD ADDwR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

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미국 FDA 규제 기기 제품 연구

아니

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