Temporomandibular Joint Internal DerangementTMJ-IDNCT07911358
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
A study testing Dextrose Prolotherapy and Sodium Hyaluronic Acid in people with Temporomandibular Joint Internal Derangement and TMJ-ID, run by Allama Iqbal Medical College at 1 site in Pakistan.
Trial summary
This is a randomized comparative study to evaluate the effectiveness of two intra-articular injections for the management of Temporomandibular Joint (TMJ) internal derangement. The study compares Dextrose Prolotherapy (12.5%) versus Sodium Hyaluronic Acid. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Temporomandibular Joint Internal Derangement, TMJ-ID, TMPDS
- What is being tested?
- Dextrose Prolotherapy and Sodium Hyaluronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2027to 25 Mar 2028
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Consenting adults (18-50 years of age) of both genders reporting to the department for treatment of clinically proven Temporomandibular joint internal derangement.
- Patients having no improvement with conservative treatment (medications, occlusal splints) over a period of 3 months.
- Patients specifically diagnosed with Wilkes Stage II (early/reducible) or Stage III (intermediate/non-reducible) internal derangement.
Who cannot join
- Patients with any co-morbid condition e.g. Uncontrolled diabetes, uncontrolled hypertension, ischemic Heart disease, epilepsy etc.
- Patients with pregnancy and lactating mothers.
- Patients suffering from autoimmune diseases (pemphigus vulgaris, pemphigoid, lupus erythematosus, sjogren syndrome).
- Patients with immunocompromised/systemic conditions.
- A known allergy to sodium hyaluronate, dextrose, or local anesthesia.
- Active inflammation or infection at the proposed injection site.
- History of previous TMJ surgery on the affected joint.
- Temporomandibular joint disorder patients with myofascial pain (without internal derangement).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Jinnah Hospital Lahore
Lahore, Punjab Province, 53720
aroub rizwan, FCPS-II Resident in Oral and M, 03494883138, aroubrizwan15@gmail.com
About this study
Official title: A Randomized Comparative Study of Sodium Hyaluronic Acid and Dextrose Prolotherapy in Management of Temporomandibular Joint Internal Derangement
This is a randomized comparative study to evaluate the effectiveness of two intra-articular injections for the management of Temporomandibular Joint (TMJ) internal derangement. The study compares Dextrose Prolotherapy (12.5%) versus Sodium Hyaluronic Acid. Sixty patients (30 per group) with clinically diagnosed TMJ internal derangement (Wilkes Stage II or III) who have not responded to conservative treatment will be enrolled. Participants will be randomly assigned to receive either a single 1ml intra-articular injection of Dextrose or Sodium Hyaluronic Acid into the superior joint space. The primary outcomes are the mean change in pain intensity (measured on a Visual Analogue Scale) and Maximum Inter-Incisal Opening (measured in millimeters) at baseline, 1 month, and 3 months post-injection.
Read the detailed description
Background: Temporomandibular joint (TMJ) internal derangement is a common disorder characterized by an abnormal positional relationship between the articular disc, condyle, and articular eminence. It affects 10-25% of individuals, predominantly middle-aged females. Treatment follows a stepwise approach, starting with conservative care (occlusal splints, pharmacotherapy, physiotherapy) and moving to minimally invasive intra-articular injections for refractory cases. Dextrose prolotherapy stimulates tissue repair through a controlled inflammatory response, while Sodium Hyaluronic Acid acts as a viscosupplement to restore joint lubrication and homeostasis. Current literature lacks sufficient direct comparisons between these two agents.
Objective: To compare the outcomes of dextrose prolotherapy versus sodium hyaluronic acid injection in terms of pain intensity and maximum mouth opening in patients with TMJ internal derangement.
Methods: This randomized controlled trial will be conducted at the Oral and Maxillofacial Surgery Department, Jinnah Hospital Lahore, over a period of 6 months after synopsis approval. A total of 60 patients (30 in each group) aged 18-50 years with clinically diagnosed TMJ internal derangement (Wilkes Stage II or III) who have not improved with conservative treatment over 3 months will be enrolled using non-probability consecutive sampling. Patients will be randomized via a random number table into Group A (receiving 1ml intra-articular injection of 12.5% Dextrose) or Group B (receiving 1ml intra-articular injection of Sodium Hyaluronate). Pain intensity (VAS) and Maximum Inter-Incisal Opening (MIO) will be recorded at baseline, 1 month, and 3 months. Data will be analyzed using SPSS version 22.0. Post-stratification t-test will be applied, and a p-value ≤ 0.05 will be considered statistically significant.
Expected Outcome: This study will provide high-quality evidence to guide clinical practice in Pakistan regarding the therapeutic equivalence of these two injection modalities for TMJ internal derangement.
- Conditions
- Temporomandibular Joint Internal Derangement, TMJ-ID, TMPDS, Disc Displacement, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Disc Displacement
- Being tested
- Dextrose Prolotherapy, Sodium Hyaluronic Acid
- Keywords
- Temporomandibular Joint, Internal Derangement, Dextrose Prolotherapy, Sodium Hyaluronic Acid, Viscosupplementation, TMJ-ID, TMJ, TMPDS, Intra-Articular Injections, Randomized Controlled Trial, prolotherapy, Minimally Invasive
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose ProlotherapyDrug
12.5% Dextrose solution (0.5ml 25% dextrose + 0.5ml 2% lidocaine) injected into the superior joint space
Sodium Hyaluronic AcidDrug
1ml of high molecular weight, non-cross-linked Sodium Hyaluronate injected into the superior joint space.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Dextrose Prolotherapy | Experimental | Participants will receive a single 1ml intra-articular injection of 12.5% Dextrose Prolotherapy (prepared by mixing 0.5ml of 25% dextrose with 0.5ml of 2% lidocaine without epinephrine) into the superior joint space of the affected TMJ. Receives: Drug: Dextrose Prolotherapy |
| Group B: Sodium Hyaluronic Acid | Active comparator | Participants will receive a single 1ml intra-articular injection of high molecular weight, non-cross-linked Sodium Hyaluronate into the superior joint space of the affected TMJ. Receives: Drug: Sodium Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Pain Scores (Visual Analogue Scale)
Change in pain intensity after dextrose or hyaluronic acid injection at 1 month and 3 months from baseline, measured on a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst pain)
Measured: Baseline, 1 month, and 3 months post-injection
Maximum Inter-Incisal Opening (MIO)
Change in maximum mouth opening measured in millimeters between the upper and lower central incisors during unassisted mouth opening using a calibrated measuring ruler.
Measured: Baseline, 1 month, and 3 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion25 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint Internal DerangementStudies of the same condition, open and under way.
- 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 will be randomized into two parallel groups using a random number table. Group A will receive a single 1ml intra-articular injection of 12.5% Dextrose Prolotherapy. Group B will receive a single 1ml intra-articular injection of Sodium Hyaluronic Acid. Both groups will be followed for 3 months post-injection.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allama Iqbal Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr.Gulraiz Zulfiqar, Study chair, Allama Iqbal Medical College,LahoreDr.Aroub Rizwan, Principal investigator, Allama Iqbal Medical College,Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911358
- Sponsor's protocol ID
- ERB197/9/04-12-2025/AIMC/JHL
- Other IDs
- DSG-2025-055-5729
- Acronym
- TMJ-ID
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to patient confidentiality and institutional ethical restrictions. Data will be reported only in aggregate form in the final publication.
Publications
Giraddi GB, Siddaraju A, Kumar B, Singh C. Internal derangement of temporomandibular joint: an evaluation of effect of corticosteroid injection compared with injection of sodium hyaluronate after arthrocentesis. J Maxillofac Oral Surg. 2012 Sep;11(3):258-63. doi: 10.1007/s12663-011-0324-8. Epub 2011 Dec 28.
PubMed 23997474Park JS, Ku JK, Kim YK, Yun PY. Efficacy of dextrose prolotherapy on temporomandibular disorder: a retrospective study. J Korean Assoc Oral Maxillofac Surg. 2024 Oct 31;50(5):259-264. doi: 10.5125/jkaoms.2024.50.5.259.
PubMed 39482101
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Study of Sodium Hyaluronic Acid and Dextrose Prolotherapy in Management of Temporomandibular Joint Internal Derangement
- ClinicalTrials.gov ID
- NCT07911358
- Acronym / sponsor ID
- TMJ-ID / ERB197/9/04-12-2025/AIMC/JHL
- Conditions
- Temporomandibular Joint Internal Derangement, TMJ-ID, TMPDS, Disc Displacement, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Disc Displacement
- Keywords
- Temporomandibular Joint, Internal Derangement, Dextrose Prolotherapy, Sodium Hyaluronic Acid, Viscosupplementation, TMJ-ID, TMJ, TMPDS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Allama Iqbal Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 25 Mar 2028 (estimated)
- First posted
- 2 Nov 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.
This is a randomized comparative study to evaluate the effectiveness of two intra-articular injections for the management of Temporomandibular Joint (TMJ) internal derangement. The study compares Dextrose Prolotherapy (12.5%) versus Sodium Hyaluronic Acid. Sixty patients (30 per group) with clinically diagnosed TMJ internal derangement (Wilkes Stage II or III) who have not responded to conservative treatment will be enrolled. Participants will be randomly assigned to receive either a single 1ml intra-articular injection of Dextrose or Sodium Hyaluronic Acid into the superior joint space. The primary outcomes are the mean change in pain intensity (measured on a Visual Analogue Scale) and Maximum Inter-Incisal Opening (measured in millimeters) at baseline, 1 month, and 3 months post-injection.
Detailed description
Background: Temporomandibular joint (TMJ) internal derangement is a common disorder characterized by an abnormal positional relationship between the articular disc, condyle, and articular eminence. It affects 10-25% of individuals, predominantly middle-aged females. Treatment follows a stepwise approach, starting with conservative care (occlusal splints, pharmacotherapy, physiotherapy) and moving to minimally invasive intra-articular injections for refractory cases. Dextrose prolotherapy stimulates tissue repair through a controlled inflammatory response, while Sodium Hyaluronic Acid acts as a viscosupplement to restore joint lubrication and homeostasis. Current literature lacks sufficient direct comparisons between these two agents.
Objective: To compare the outcomes of dextrose prolotherapy versus sodium hyaluronic acid injection in terms of pain intensity and maximum mouth opening in patients with TMJ internal derangement.
Methods: This randomized controlled trial will be conducted at the Oral and Maxillofacial Surgery Department, Jinnah Hospital Lahore, over a period of 6 months after synopsis approval. A total of 60 patients (30 in each group) aged 18-50 years with clinically diagnosed TMJ internal derangement (Wilkes Stage II or III) who have not improved with conservative treatment over 3 months will be enrolled using non-probability consecutive sampling. Patients will be randomized via a random number table into Group A (receiving 1ml intra-articular injection of 12.5% Dextrose) or Group B (receiving 1ml intra-articular injection of Sodium Hyaluronate). Pain intensity (VAS) and Maximum Inter-Incisal Opening (MIO) will be recorded at baseline, 1 month, and 3 months. Data will be analyzed using SPSS version 22.0. Post-stratification t-test will be applied, and a p-value ≤ 0.05 will be considered statistically significant.
Expected Outcome: This study will provide high-quality evidence to guide clinical practice in Pakistan regarding the therapeutic equivalence of these two injection modalities for TMJ internal derangement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel groups using a random number table. Group A will receive a single 1ml intra-articular injection of 12.5% Dextrose Prolotherapy. Group B will receive a single 1ml intra-articular injection of Sodium Hyaluronic Acid. Both groups will be followed for 3 months post-injection.
| Arm | Type | Receives |
|---|---|---|
| Group A: Dextrose Prolotherapy | Experimental | Drug: Dextrose ProlotherapyParticipants will receive a single 1ml intra-articular injection of 12.5% Dextrose Prolotherapy (prepared by mixing 0.5ml of 25% dextrose with 0.5ml of 2% lidocaine without epinephrine) into the superior joint space of the affected TMJ. |
| Group B: Sodium Hyaluronic Acid | Active comparator | Drug: Sodium Hyaluronic AcidParticipants will receive a single 1ml intra-articular injection of high molecular weight, non-cross-linked Sodium Hyaluronate into the superior joint space of the affected TMJ. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Consenting adults (18-50 years of age) of both genders reporting to the department for treatment of clinically proven Temporomandibular joint internal derangement.
- Patients having no improvement with conservative treatment (medications, occlusal splints) over a period of 3 months.
- Patients specifically diagnosed with Wilkes Stage II (early/reducible) or Stage III (intermediate/non-reducible) internal derangement.
Key exclusion criteria (8 listed)
- Patients with any co-morbid condition e.g. Uncontrolled diabetes, uncontrolled hypertension, ischemic Heart disease, epilepsy etc.
- Patients with pregnancy and lactating mothers.
- Patients suffering from autoimmune diseases (pemphigus vulgaris, pemphigoid, lupus erythematosus, sjogren syndrome).
- Patients with immunocompromised/systemic conditions.
- A known allergy to sodium hyaluronate, dextrose, or local anesthesia.
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 Prolotherapy12.5% Dextrose solution (0.5ml 25% dextrose + 0.5ml 2% lidocaine) injected into the superior joint space | Drug | Group A: Dextrose Prolotherapy |
| Sodium Hyaluronic Acid1ml of high molecular weight, non-cross-linked Sodium Hyaluronate injected into the superior joint space. | Drug | Group B: Sodium Hyaluronic Acid |
Primary outcome
Mean Change in Pain Scores (Visual Analogue Scale)
Time frame: Baseline, 1 month, and 3 months post-injection
Change in pain intensity after dextrose or hyaluronic acid injection at 1 month and 3 months from baseline, measured on a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst pain)
Maximum Inter-Incisal Opening (MIO)
Time frame: Baseline, 1 month, and 3 months post-injection
Change in maximum mouth opening measured in millimeters between the upper and lower central incisors during unassisted mouth opening using a calibrated measuring ruler.
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 2 Nov 2026.
- Results publication: PubMed 23997474Giraddi GB, Siddaraju A, Kumar B, Singh C. Internal derangement of temporomandibular joint: an evaluation of effect of corticosteroid injection compared with injection of sodium hyaluronate after arthrocentesis. J Maxillofac Oral Surg. 2012 Sep;11(3):258-63. doi: 10.1007/s12663-011-0324-8. Epub 2011 Dec 28.
- Results publication: PubMed 39482101Park JS, Ku JK, Kim YK, Yun PY. Efficacy of dextrose prolotherapy on temporomandibular disorder: a retrospective study. J Korean Assoc Oral Maxillofac Surg. 2024 Oct 31;50(5):259-264. doi: 10.5125/jkaoms.2024.50.5.259.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to patient confidentiality and institutional ethical restrictions. Data will be reported only in aggregate form in the final publication.
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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.
Dr.Gulraiz Zulfiqar study chair
Allama Iqbal Medical College,Lahore
Dr.Aroub Rizwan principal investigator
Allama Iqbal Medical College,Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextrose Prolotherapy and Sodium Hyaluronic Acid in people with Temporomandibular Joint Internal Derangement and TMJ-ID, run by Allama Iqbal Medical College at 1 site in Pakistan.
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 3 inclusion and 8 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 2 Nov 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 Pakistan. 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?
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 Aroub Rizwan, BDS (03494883138, aroubrizwan15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Pain Scores (Visual Analogue Scale) (time frame: Baseline, 1 month, and 3 months post-injection). The study lists 2 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 NCT07911358, which also lists 2 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 2 Nov 2026.