Clinical trial NCT07020455: Is the Combine Prolotherapy More Effective Than the Traditional Prolotherapy in Patients With Temporomandibular Joint Hypermobility?
Official title: Is The Combine Prolotherapy More Effective Than The Traditional Prolotherapy In Patients With Temporomandibular Joint Hypermobility?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Temporomandibular Disorders (TMD)
Temporomandibular Pain
Hypermobility Syndrome (Disorder)
Hypermobility, Joint
Arthrocentesis
Prolotherapy
Keywords: hypermobility
subluxation
prolotherapy
arthrocentesis
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 26
Sex: ALL
Minimum age (years): 17
Maximum age (years): 46
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The first group applied prolotherapy, while the other group applied arthrocentesis and prolotherapy together.
Primary purpose: TREATMENT

Brief summary: 1. Diagnosis and Indication You have been diagnosed with temporomandibular joint (TMJ) hypermobility and/or dysfunction, characterized by symptoms such as jaw clicking, locking, pain in the joint area, or difficulty in opening and closing the mouth. After clinical and radiographic evaluation, the recommended treatment includes arthrocentesis and prolotherapy, either alone or in combination.
2. Description of Procedures

   A. TMJ Arthrocentesis:

   This is a minimally invasive procedure in which small needles are inserted into the TMJ space to irrigate the joint using sterile fluid (e.g., Ringer's solution). The procedure aims to eliminate inflammatory mediators, release joint adhesions, and improve mandibular mobility. It is generally performed under local anesthesia in an outpatient setting.

   B. Prolotherapy:

   Prolotherapy involves the injection of an irritant solution (typically dextrose combined with a local anesthetic) into the joint capsule, ligaments, or surrounding tissue. The goal is to stimulate the body's natural healing response, promoting collagen production and tissue regeneration to improve joint stability and function.

   C. Combined Approach:

   In certain cases, both treatments may be performed during the same session to maximize clinical benefit-arthrocentesis addresses inflammation and mobility, while prolotherapy enhances long-term stabilization.
3. Benefits and Expected Outcomes Reduction in TMJ pain and joint clicking

   Improved jaw function and range of motion

   Stabilization of the joint and reduced recurrence of dislocation or subluxation

   Minimally invasive and generally well-tolerated
4. Possible Risks and Complications

   Although these procedures are generally safe, potential risks may include but are not limited to:

   Mild pain or swelling at the injection site

   Temporary facial numbness or weakness (rare and usually self-resolving)

   Dizziness or light-headedness

   Joint stiffness or infection (very rare)

   Allergic reaction to anesthetic or injected substances
5. Alternatives to the Proposed Procedure

   You have the right to consider other treatment options, which may include:

   Physical therapy or jaw exercises

   Oral splints or bite guards

   Medication (analgesics, muscle relaxants)

   Surgical interventions (if conservative methods fail)
6. Patient Instructions and Post-Procedure Care Avoid wide mouth opening, yawning, or chewing hard foods for several days

Use only recommended medications (e.g., acetaminophen/paracetamol); avoid anti-inflammatory drugs unless advised otherwise

Apply cold compresses to reduce swelling if necessary

Attend all scheduled follow-up appointments

Notify your doctor immediately if you experience severe pain, prolonged numbness, fever, or signs of infection


Eligibility criteria: Inclusion Criteria:

* patients with unilateral or bilateral TMJ hypermobility
* history of open locking
* complaints of joint sounds and facial pain
* treated with combine or traditionally prolotherapy
* followed for at least 3 months
* the diagnosis of the patients was confirmed by TMJ radiography

Exclusion Criteria:

* patients who underwent discectomy
* patients with active infection (fever, redness, oedema, loss of function, etc.)
* pathological findings (tumour, cyst, etc.) in the related area were excluded
* patients with systemic disorders that could affect the results

Primary outcomes:
measure: Pain intensity of TMJ
timeFrame: From pre-treatment to the 3rd month after treatment
Secondary outcomes:
measure: Maximal interincisal opening (MIO)
timeFrame: From pre-treatment to the 3rd month after treatment
Other outcomes:
measure: TMJ sounds
timeFrame: From pre-treatment to the 3rd month after treatment
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
References:
citation: Comert Kilic S, Gungormus M. Is dextrose prolotherapy superior to placebo for the treatment of temporomandibular joint hypermobility? A randomized clinical trial. Int J Oral Maxillofac Surg. 2016 Jul;45(7):813-9. doi: 10.1016/j.ijom.2016.01.006. Epub 2016 Feb 2.
citation: Dasukil S, Shetty SK, Arora G, Degala S. Efficacy of Prolotherapy in Temporomandibular Joint Disorders: An Exploratory Study. J Maxillofac Oral Surg. 2021 Mar;20(1):115-120. doi: 10.1007/s12663-020-01328-9. Epub 2020 Jan 13.
citation: Taskesen F, Cezairli B. Efficacy of prolotherapy and arthrocentesis in management of temporomandibular joint hypermobility. Cranio. 2023 Sep;41(5):423-431. doi: 10.1080/08869634.2020.1861887. Epub 2020 Dec 16.
citation: Cezairli B, Sivrikaya EC, Omezli MM, Ayranci F, Seyhan Cezairli N. Results of Combined, Single-Session Arthrocentesis and Dextrose Prolotherapy for Symptomatic Temporomandibular Joint Syndrome: A Case Series. J Altern Complement Med. 2017 Oct;23(10):771-777. doi: 10.1089/acm.2017.0068. Epub 2017 Oct 10.
citation: Abbadi W, Kara Beit Z, Al-Khanati NM. Arthrocentesis, Injectable Platelet-Rich Plasma and Combination of Both Protocols of Temporomandibular Joint Disorders Management: A Single-Blinded Randomized Clinical Trial. Cureus. 2022 Nov 11;14(11):e31396. doi: 10.7759/cureus.31396. eCollection 2022 Nov.
citation: Dagenais S, Wooley J, Hite M, Green R, Mayer J. Acute toxicity evaluation of proliferol: a dose-escalating, placebo-controlled study in swine. Int J Toxicol. 2009 May-Jun;28(3):219-29. doi: 10.1177/1091581809336478.
citation: Refai H. Long-term therapeutic effects of dextrose prolotherapy in patients with hypermobility of the temporomandibular joint: a single-arm study with 1-4 years' follow up. Br J Oral Maxillofac Surg. 2017 Jun;55(5):465-470. doi: 10.1016/j.bjoms.2016.12.002. Epub 2017 Apr 29.
citation: Gibaly A, Abdelmoiz M, Alghandour AN. Evaluation of the effect of dextrose prolotherapy versus deep dry needling therapy for the treatment of temporomandibular joint anterior disc displacement with reduction: (a randomized controlled trial). Clin Oral Investig. 2024 Aug 8;28(9):475. doi: 10.1007/s00784-024-05830-z.
citation: Zhou H, Hu K, Ding Y. Modified dextrose prolotherapy for recurrent temporomandibular joint dislocation. Br J Oral Maxillofac Surg. 2014 Jan;52(1):63-6. doi: 10.1016/j.bjoms.2013.08.018. Epub 2013 Sep 21.
citation: Ungor C, Atasoy KT, Taskesen F, Cezairli B, Dayisoylu EH, Tosun E, Senel FC. Short-term results of prolotherapy in the management of temporomandibular joint dislocation. J Craniofac Surg. 2013 Mar;24(2):411-5. doi: 10.1097/SCS.0b013e31827ff14f.
citation: Nagori SA, Jose A, Gopalakrishnan V, Roy ID, Chattopadhyay PK, Roychoudhury A. The efficacy of dextrose prolotherapy over placebo for temporomandibular joint hypermobility: A systematic review and meta-analysis. J Oral Rehabil. 2018 Dec;45(12):998-1006. doi: 10.1111/joor.12698. Epub 2018 Aug 3.
citation: Foster TE, Puskas BL, Mandelbaum BR, Gerhardt MB, Rodeo SA. Platelet-rich plasma: from basic science to clinical applications. Am J Sports Med. 2009 Nov;37(11):2259-72. doi: 10.1177/0363546509349921.
citation: Distel LM, Best TM. Prolotherapy: a clinical review of its role in treating chronic musculoskeletal pain. PM R. 2011 Jun;3(6 Suppl 1):S78-81. doi: 10.1016/j.pmrj.2011.04.003.
citation: Nitzan DW, Dolwick MF, Martinez GA. Temporomandibular joint arthrocentesis: a simplified treatment for severe, limited mouth opening. J Oral Maxillofac Surg. 1991 Nov;49(11):1163-7; discussion 1168-70. doi: 10.1016/0278-2391(91)90409-f.
citation: Rabago D, Slattengren A, Zgierska A. Prolotherapy in primary care practice. Prim Care. 2010 Mar;37(1):65-80. doi: 10.1016/j.pop.2009.09.013.
citation: Mustafa R, Gungormus M, Mollaoglu N. Evaluation of the Efficacy of Different Concentrations of Dextrose Prolotherapy in Temporomandibular Joint Hypermobility Treatment. J Craniofac Surg. 2018 Jul;29(5):e461-e465. doi: 10.1097/SCS.0000000000004480.
citation: de Farias JF, Melo SL, Bento PM, Oliveira LS, Campos PS, de Melo DP. Correlation between temporomandibular joint morphology and disc displacement by MRI. Dentomaxillofac Radiol. 2015;44(7):20150023. doi: 10.1259/dmfr.20150023. Epub 2015 Mar 25.
citation: Majumdar SK, Krishna S, Chatterjee A, Chakraborty R, Ansari N. Single Injection Technique Prolotherapy for Hypermobility Disorders of TMJ Using 25 % Dextrose: A Clinical Study. J Maxillofac Oral Surg. 2017 Jun;16(2):226-230. doi: 10.1007/s12663-016-0944-0. Epub 2016 Jul 25.
citation: Refai H, Altahhan O, Elsharkawy R. The efficacy of dextrose prolotherapy for temporomandibular joint hypermobility: a preliminary prospective, randomized, double-blind, placebo-controlled clinical trial. J Oral Maxillofac Surg. 2011 Dec;69(12):2962-70. doi: 10.1016/j.joms.2011.02.128. Epub 2011 Jul 16.
citation: Torres DE, McCain JP. Arthroscopic electrothermal capsulorrhaphy for the treatment of recurrent temporomandibular joint dislocation. Int J Oral Maxillofac Surg. 2012 Jun;41(6):681-9. doi: 10.1016/j.ijom.2012.03.008. Epub 2012 Apr 7.