An interventional study of Dextrose Prolotherapy and Sodium Hyaluronic Acid in Temporomandibular Joint Internal Derangement, TMJ-ID and TMPDS, sponsored by Allama Iqbal Medical College. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Allama Iqbal Medical College · Not applicable, Interventional, and Treatment
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.
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.
416 studies on the registry are indexed under Temporomandibular Joint Dysfunction Syndrome; 69 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 301 interventional studies indexed under Temporomandibular Joint Dysfunction Syndrome.
Browse Temporomandibular Joint Dysfunction Syndrome studies →Allama Iqbal Medical College is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
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Consenting adults (18-50 years of age) of both genders reporting to the department for treatment of clinically proven Temporomandibular joint internal derangement.
Exclusion Criteria:
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.
Drug: Dextrose Prolotherapy
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.
Drug: Sodium Hyaluronic Acid
12.5% Dextrose solution (0.5ml 25% dextrose + 0.5ml 2% lidocaine) injected into the superior joint space
1ml of high molecular weight, non-cross-linked Sodium Hyaluronate injected into the superior joint space.
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)
Time frame: 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.
Time frame: Baseline, 1 month, and 3 months post-injection
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Plan to share: 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.
Start is estimated for Jan 2027; primary completion for Jan 2028, 12 months later.
Of 150 non-industry interventional studies with no phase under Temporomandibular Joint Dysfunction Syndrome, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 20. This study's planned 12 months is above that.
Counting every sponsor, half of 151 studies reached it within 9 months; a quarter within 5 and three quarters within 18.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Glucose
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Allama Iqbal Medical College