Evaluation of Intra-articular Injection of Hyaluronic Acid Versus Radiofrequency Current in Management of Reduced TMJ Disc Displacement
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Asyut Governorate
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Asyut, Asyut Governorate, Egypt
- Faculty of dental medicine , Al Azhar university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients over 18 years of age.
- Patients were diagnosed with internal derangement of TMJ. (Anterior disc displacement with reduction)
- TMJ pain of non-odontogenic origin as confirmed by Research Diagnostic Criteria (RDC) for TMD/RDC axis II.
- Pain on chewing or maximal mouth opening with a duration of at least 3 months.
Patients were accepted study condition and agree to attend to schedule follow up.
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Exclusion Criteria:
- Anterior disc displacement without reduction
- Trauma cases
- Polyarthritis as rheumatoid
- Cases that had contraindication to perform MRI scan.
- 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. -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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HA injection
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Experimental: 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.
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Procedure of RF current
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Experimental: HA injection + Radio-frequency (combination therapy )
Combination therapy
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HA injection
Procedure of RF current
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Maximum Mouth Opening (MMO)
Time Frame: Baseline, 1 week, 1 month, and 4 months after treatment.
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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.
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Baseline, 1 week, 1 month, and 4 months after treatment.
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TMJ sounds
Time Frame: Baseline, 1 week, 1 month, and 4 months after treatment.
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TMJ clicking was detected by a stethoscope if it was not audible during asking patient to open and close his mouth.
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Baseline, 1 week, 1 month, and 4 months after treatment.
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Pain intensity measured by (Visual Analog Scale)
Time Frame: Baseline, 1 week, 1 month, and 4 months after treatment.
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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.
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Baseline, 1 week, 1 month, and 4 months after treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Radiographic
Time Frame: Baseline and 4 months after treatment.
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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.
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Baseline and 4 months after treatment.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Jo JH, Jang Y, Chung G, Chung JW, Park JW. Long-term efficacy and patient satisfaction of pulsed radiofrequency therapy in temporomandibular disorders: A randomized controlled trial. Medicine (Baltimore). 2021 Dec 30;100(52):e28441. doi: 10.1097/MD.0000000000028441.
- Pihut M, Gornicki M, Orczykowska M, Zarzecka E, Ryniewicz W, Gala A. The Application of Radiofrequency Waves in Supportive Treatment of Temporomandibular Disorders. Pain Res Manag. 2020 May 6;2020:6195601. doi: 10.1155/2020/6195601. eCollection 2020.
- Abouelhuda AM, Khalifa AK, Kim YK, Hegazy SA. Non-invasive different modalities of treatment for temporomandibular disorders: review of literature. J Korean Assoc Oral Maxillofac Surg. 2018 Apr;44(2):43-51. doi: 10.5125/jkaoms.2018.44.2.43. Epub 2018 Apr 25.
- Korkmaz YT, Altintas NY, Korkmaz FM, Candirli C, Coskun U, Durmuslar MC. Is Hyaluronic Acid Injection Effective for the Treatment of Temporomandibular Joint Disc Displacement With Reduction? J Oral Maxillofac Surg. 2016 Sep;74(9):1728-40. doi: 10.1016/j.joms.2016.03.005. Epub 2016 Mar 15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HA inject vs RF in TMD ADDwR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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