TMJ Disc Displacement With ReductionNCT07802236
Evaluation of Intra-articular Injection of Hyaluronic Acid Versus Radiofrequency Current in Management of Reduced TMJ Disc Displacement
A study testing Hyalouronic acid and Radiofrequency in people with TMJ Disc Displacement With Reduction, run by Al-Azhar University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- TMJ Disc Displacement With Reduction
- What is being tested?
- Hyalouronic acid and Radiofrequency
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2023to 10 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- -
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dental medicine , Al Azhar university
Asyut, Asyut Governorate
About this study
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.
Read the 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.
- Conditions
- TMJ Disc Displacement With Reduction
- Being tested
- Hyalouronic acid, Radiofrequency
- Keywords
- TMJ, HA injection, Radio-frequency, ADDwR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyalouronic acidDrug
HA injection
RadiofrequencyDevice
Procedure of RF current
| Study group | Role | What they receive |
|---|---|---|
| HA injection | Experimental | 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. Receives: Drug: Hyalouronic acid |
| Radio-frequency | Experimental | 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. Receives: Device: Radiofrequency |
| HA injection + Radio-frequency (combination therapy ) | Experimental | Combination therapy Receives: Drug: Hyalouronic acid; Device: Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by (Visual Analog Scale)
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.
Measured: Baseline, 1 week, 1 month, and 4 months after treatment.
Maximum Mouth Opening (MMO)
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.
Measured: Baseline, 1 week, 1 month, and 4 months after treatment.
TMJ sounds
TMJ clicking was detected by a stethoscope if it was not audible during asking patient to open and close his mouth.
Measured: Baseline, 1 week, 1 month, and 4 months after treatment.
Secondary outcomes (1)
Radiographic
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.
Measured: Baseline and 4 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start10 Apr 2023
- Primary completion10 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for TMJ Disc Displacement With ReductionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly allocated into three parallel groups: Group 1 received intra-articular hyaluronic acid injection, Group 2 received radiofrequency therapy, and Group 3 received a combination of hyaluronic acid injection and radiofrequency therapy.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Kamal Abdelaal Mohamed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802236
- Sponsor's protocol ID
- HA inject vs RF in TMD ADDwR
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34967382Pihut 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.
PubMed 32454921Abouelhuda 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.
PubMed 29732308Korkmaz 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.
PubMed 27058964
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intra-articular Injection of Hyaluronic Acid Versus Radiofrequency Current in Management of Reduced TMJ Disc Displacement
- ClinicalTrials.gov ID
- NCT07802236
- Acronym / sponsor ID
- HA inject vs RF in TMD ADDwR
- Conditions
- TMJ Disc Displacement With Reduction
- Keywords
- TMJ, HA injection, Radio-frequency, ADDwR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly allocated into three parallel groups: Group 1 received intra-articular hyaluronic acid injection, Group 2 received radiofrequency therapy, and Group 3 received a combination of hyaluronic acid injection and radiofrequency therapy.
| Arm | Type | Receives |
|---|---|---|
| HA injection | Experimental | Drug: Hyalouronic acidThe 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. |
| Radio-frequency | Experimental | Device: Radiofrequencywill 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. |
| HA injection + Radio-frequency (combination therapy ) | Experimental | Drug: Hyalouronic acid, Device: RadiofrequencyCombination therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyalouronic acidHA injection | Drug | HA injection, HA injection + Radio-frequency (combination therapy ) |
| RadiofrequencyProcedure of RF current | Device | HA injection + Radio-frequency (combination therapy ), Radio-frequency |
Primary outcome
Pain intensity measured by (Visual Analog Scale)
Time frame: 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.
Maximum Mouth Opening (MMO)
Time frame: 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.
TMJ sounds
Time frame: 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.
1 secondary outcome
Radiographic
Time frame: Baseline and 4 months after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 34967382Jo 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.
- Background: PubMed 32454921Pihut 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.
- Background: PubMed 29732308Abouelhuda 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.
- Background: PubMed 27058964Korkmaz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyalouronic acid and Radiofrequency in people with TMJ Disc Displacement With Reduction, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured by (Visual Analog Scale) (time frame: Baseline, 1 week, 1 month, and 4 months after treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07802236, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.