TMJ Disc DisorderNCT07129681
a Comparison of the Outcomes Following Intra-articular Dextrose 5% Injection Versus Arthrocentesis in Patients With Anterior Disc Displacement With Reduction of the Tomporomandibular Joint
A study testing dextrose 5% and Arthrocentesis/Saline in people with TMJ Disc Disorder, run by Cairo University.
Trial summary
The Aim of this study is to evaluate the efficacy of intra-articular Dextrose injection with concentration 5% in superior joint space of TMJ in comparison to arthrocentesis in patients with anterior disc displacement with reduction of TMJ who did not respond favorably to conservative treatment and to compare and infer… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- TMJ Disc Disorder
- What is being tested?
- dextrose 5% and Arthrocentesis/Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Patients diagnosed with anterior disc displacement with reduction of TMJ with pain,limited mouth opening and
- painful clicking who underwent conservative therapy with physiotherapy but failed to receive any relief after 3
- months of conservative therapy.
- Age ranges from 18 to 50 years.
- Patients with adequate follow up duration for outcome assessment.
Who cannot join
- Patients having pain or reduced mouth opening due to fracture of the condyle.
- patients having any degenerative changes in the TMJ.
- patients having other systemic diseases such as polyarthritis.
- patients having any neurological disorders.
- Pregnant and lactating women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Comparison of the Outcomes Following Intra-articular Dextrose 5% Injection Versus Arthrocentesis in Patients With Anterior Disc Displacement With Reduction of the Temporomandibular Joint.
The Aim of this study is to evaluate the efficacy of intra-articular Dextrose injection with
concentration 5% in superior joint space of TMJ in comparison to arthrocentesis in patients with
anterior disc displacement with reduction of TMJ who did not respond favorably to conservative
treatment and to compare and infer which among the two procedures is more satisfactory,
whether dextrose 5% injection or Arthrocentesis.
Read the detailed description
The Aim of this study is to evaluate the efficacy of intra-articular Dextrose injection with
concentration 5% in superior joint space of TMJ in comparison to arthrocentesis in patients with
anterior disc displacement with reduction of TMJ who did not respond favorably to conservative
treatment and to compare and infer which among the two procedures is more satisfactory,
whether dextrose 5% injection or Arthrocentesis.
- Conditions
- TMJ Disc Disorder
- Being tested
- dextrose 5%, Arthrocentesis/Saline
- Keywords
- TMJ, Disc displacement with reduction, Dextrose 5%, Arthrocentesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dextrose 5%Other
Dextrose, is an osmotic proliferant which acts by dehydrating the cells at the injection site which utlimately leads to release of cellular fragments that act as chemo attractants and start the inflammatory cascade leading todeposition of collagen
Arthrocentesis/SalineOther
Arthrocentesis , a highly successful, simple and minimally invasive procedure is a safe and simple method for treatment of anterior disc displacement with reduction of TMJ both in short term and long term follow up period, where it is a procedure of removing damaged tissues \&inflammatory mediators.it can be the treatment modality for the for control group
| Study group | Role | What they receive |
|---|---|---|
| Group 1 patients with anterior disc displacement with reduction | Active comparator | Not described Receives: Other: dextrose 5% |
| Group 2 patients with anterior disc displacement of reduction | Experimental | Not described Receives: Other: Arthrocentesis/Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Severity Measured by Numerical Rating Scale (NRS)
Primary Outcome Measure:
- Change in Pain Severity Measured by Numerical Rating Scale (NRS)
Pain severity will be assessed using the Numerical Rating Scale (NRS) (0-10), where 0 = no pain and 10 = severe
pain. Participants will report their pain levels at each time point. The mean change in NRS scores from baseline will be
calculated and analyzed . Data Aggregation: Mean change in NRS score
Measured: Measured at baseline, 3 days and 3 months after injection
Secondary outcomes (1)
Change in Maximal Interincisal Opening (MIO) Measured in Millimeters
Maximal interincisal opening (MIO) will be measured using a sterilllized metal scale or a digital caliper, with values recorded in millimeters (mm).
The mean change in MIO from baseline will be reported . Data Aggregation: Mean change in MIO (mm) with standard
deviation (SD).
Measured: Measured at baseline, 3 days and 3 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for TMJ Disc DisorderStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandy maged habib ibrahim, Cairo University
- Investigators
- Moustafa Mohamed Talaat, Cairo assistant professor, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129681
- Sponsor's protocol ID
- dextrose 5% injection in TMJ
- Status last verified
- Aug 2025
- First submitted
- 12 Jul 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karadayi U, Gursoytrak B. Randomised controlled trial of arthrocentesis with or without PRF for internal derangement of the TMJ. J Craniomaxillofac Surg. 2021 May;49(5):362-367. doi: 10.1016/j.jcms.2021.01.018. Epub 2021 Feb 5.
PubMed 33581954Young AL. Internal derangements of the temporomandibular joint: A review of the anatomy, diagnosis, and management. J Indian Prosthodont Soc. 2015 Jan-Mar;15(1):2-7. doi: 10.4103/0972-4052.156998.
PubMed 26929478Maniquis-Smigel L, Dean Reeves K, Jeffrey Rosen H, Lyftogt J, Graham-Coleman C, Cheng AL, Rabago D. Short Term Analgesic Effects of 5% Dextrose Epidural Injections for Chronic Low Back Pain: A Randomized Controlled Trial. Anesth Pain Med. 2016 Dec 6;7(1):e42550. doi: 10.5812/aapm.42550. eCollection 2017 Feb.
PubMed 28920043Rabago D, Mundt M, Zgierska A, Grettie J. Hypertonic dextrose injection (prolotherapy) for knee osteoarthritis: Long term outcomes. Complement Ther Med. 2015 Jun;23(3):388-95. doi: 10.1016/j.ctim.2015.04.003. Epub 2015 Apr 8.
PubMed 26051574Fouda AA. Change of site of intra-articular injection of hypertonic dextrose resulted in different effects of treatment. Br J Oral Maxillofac Surg. 2018 Oct;56(8):715-718. doi: 10.1016/j.bjoms.2018.07.022. Epub 2018 Aug 11.
PubMed 30107954Singh SU, Prasad RB, Punga R, Datta R, Singh N. A comparison of the outcomes following intra-articular steroid injection alone or arthrocentesis alone in the management of internal derangement of the temporomandibular joint. Natl J Maxillofac Surg. 2022 Aug;13(Suppl 1):S80-S84. doi: 10.4103/njms.njms_291_21. Epub 2022 Aug 20.
PubMed 36393924Li TY, Chen SR, Shen YP, Chang CY, Su YC, Chen LC, Wu YT. Long-term outcome after perineural injection with 5% dextrose for carpal tunnel syndrome: a retrospective follow-up study. Rheumatology (Oxford). 2021 Feb 1;60(2):881-887. doi: 10.1093/rheumatology/keaa361.
PubMed 32856082
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Outcomes Following Intra-articular Dextrose 5% Injection Versus Arthrocentesis in Patients With Anterior Disc Displacement With Reduction of the Temporomandibular Joint.
- ClinicalTrials.gov ID
- NCT07129681
- Acronym / sponsor ID
- dextrose 5% injection in TMJ
- Conditions
- TMJ Disc Disorder
- Keywords
- TMJ, Disc displacement with reduction, Dextrose 5%, Arthrocentesis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Aug 2025 (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.
The Aim of this study is to evaluate the efficacy of intra-articular Dextrose injection with
concentration 5% in superior joint space of TMJ in comparison to arthrocentesis in patients with
anterior disc displacement with reduction of TMJ who did not respond favorably to conservative
treatment and to compare and infer which among the two procedures is more satisfactory,
whether dextrose 5% injection or Arthrocentesis.
Detailed description
The Aim of this study is to evaluate the efficacy of intra-articular Dextrose injection with
concentration 5% in superior joint space of TMJ in comparison to arthrocentesis in patients with
anterior disc displacement with reduction of TMJ who did not respond favorably to conservative
treatment and to compare and infer which among the two procedures is more satisfactory,
whether dextrose 5% injection or Arthrocentesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 patients with anterior disc displacement with reduction | Active comparator | Other: dextrose 5% |
| Group 2 patients with anterior disc displacement of reduction | Experimental | Other: Arthrocentesis/Saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- -Patients diagnosed with anterior disc displacement with reduction of TMJ with pain,limited mouth opening and
- painful clicking who underwent conservative therapy with physiotherapy but failed to receive any relief after 3
- months of conservative therapy.
- Age ranges from 18 to 50 years.
- Patients with adequate follow up duration for outcome assessment.
Key exclusion criteria (5 listed)
- Patients having pain or reduced mouth opening due to fracture of the condyle.
- patients having any degenerative changes in the TMJ.
- patients having other systemic diseases such as polyarthritis.
- patients having any neurological disorders.
- Pregnant and lactating women.
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 |
|---|---|---|
| dextrose 5%Dextrose, is an osmotic proliferant which acts by dehydrating the cells at the injection site which utlimately leads to release of cellular fragments that act as chemo attractants and start the inflammatory cascade leading todeposition of collagen | Other | Group 1 patients with anterior disc displacement with reduction |
| Arthrocentesis/SalineArthrocentesis , a highly successful, simple and minimally invasive procedure is a safe and simple method for treatment of anterior disc displacement with reduction of TMJ both in short term and long term follow up period, where it is a procedure of removing damaged tissues \&inflammatory mediators.it can be the treatment modality for the for control group | Other | Group 2 patients with anterior disc displacement of reduction |
Primary outcome
Change in Pain Severity Measured by Numerical Rating Scale (NRS)
Time frame: Measured at baseline, 3 days and 3 months after injection
Primary Outcome Measure: 1. Change in Pain Severity Measured by Numerical Rating Scale (NRS) Pain severity will be assessed using the Numerical Rating Scale (NRS) (0-10), where 0 = no pain and 10 = severe pain. Participants will report their pain levels at each time point. The mean change in NRS scores from baseline will be calculated and analyzed . Data Aggregation: Mean change in NRS score
1 secondary outcome
Change in Maximal Interincisal Opening (MIO) Measured in Millimeters
Time frame: Measured at baseline, 3 days and 3 months after injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Background: PubMed 33581954Karadayi U, Gursoytrak B. Randomised controlled trial of arthrocentesis with or without PRF for internal derangement of the TMJ. J Craniomaxillofac Surg. 2021 May;49(5):362-367. doi: 10.1016/j.jcms.2021.01.018. Epub 2021 Feb 5.
- Background: PubMed 26929478Young AL. Internal derangements of the temporomandibular joint: A review of the anatomy, diagnosis, and management. J Indian Prosthodont Soc. 2015 Jan-Mar;15(1):2-7. doi: 10.4103/0972-4052.156998.
- Background: PubMed 28920043Maniquis-Smigel L, Dean Reeves K, Jeffrey Rosen H, Lyftogt J, Graham-Coleman C, Cheng AL, Rabago D. Short Term Analgesic Effects of 5% Dextrose Epidural Injections for Chronic Low Back Pain: A Randomized Controlled Trial. Anesth Pain Med. 2016 Dec 6;7(1):e42550. doi: 10.5812/aapm.42550. eCollection 2017 Feb.
- Background: PubMed 26051574Rabago D, Mundt M, Zgierska A, Grettie J. Hypertonic dextrose injection (prolotherapy) for knee osteoarthritis: Long term outcomes. Complement Ther Med. 2015 Jun;23(3):388-95. doi: 10.1016/j.ctim.2015.04.003. Epub 2015 Apr 8.
- Background: PubMed 30107954Fouda AA. Change of site of intra-articular injection of hypertonic dextrose resulted in different effects of treatment. Br J Oral Maxillofac Surg. 2018 Oct;56(8):715-718. doi: 10.1016/j.bjoms.2018.07.022. Epub 2018 Aug 11.
- Background: PubMed 36393924Singh SU, Prasad RB, Punga R, Datta R, Singh N. A comparison of the outcomes following intra-articular steroid injection alone or arthrocentesis alone in the management of internal derangement of the temporomandibular joint. Natl J Maxillofac Surg. 2022 Aug;13(Suppl 1):S80-S84. doi: 10.4103/njms.njms_291_21. Epub 2022 Aug 20.
- Background: PubMed 32856082Li TY, Chen SR, Shen YP, Chang CY, Su YC, Chen LC, Wu YT. Long-term outcome after perineural injection with 5% dextrose for carpal tunnel syndrome: a retrospective follow-up study. Rheumatology (Oxford). 2021 Feb 1;60(2):881-887. doi: 10.1093/rheumatology/keaa361.
- Individual participant dataSharing planned: No
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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.
Moustafa Mohamed Talaat, Cairo assistant professor, PHD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing dextrose 5% and Arthrocentesis/Saline in people with TMJ Disc Disorder, run by Cairo University.
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 5 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: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandy Maged Ibrahim, bachelor's degree (+201149119389, sandy.habib@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Severity Measured by Numerical Rating Scale (NRS) (time frame: Measured at baseline, 3 days and 3 months after injection). 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 NCT07129681, which also lists 7 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 19 Aug 2025.