Is the Combine Prolotherapy More Effective Than the Traditional Prolotherapy in Patients With Temporomandibular Joint Hypermobility?

NCT07020455 | Completed Phase 4

• 1 other identifier: 2025/6
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Description of Procedures
3. 3.Benefits and Expected Outcomes Reduction in TMJ pain and joint clicking
4. 4.Possible Risks and Complications
5. 5.Alternatives to the Proposed Procedure
6. 6.Patient Instructions and Post-Procedure Care Avoid wide mouth opening, yawning, or chewing hard foods for several days

Conditions

Temporomandibular Disorders (TMD); Temporomandibular Pain; Hypermobility Syndrome (Disorder); Hypermobility, Joint; Arthrocentesis; Prolotherapy

Keywords

hypermobility; subluxation; prolotherapy; arthrocentesis

Outcome Measures

Primary Outcomes (1)

• Pain intensity of TMJ

  Pain intensity of TMJ evaluated by visual analog scale (VAS) questionnaire. VAS is designated by an marked horizontal line, 10 mm long, scored from 0 (no pain) to 10 (intolerable pain), anchored by word identifiers at each end. Patients marked the point on the line that they thought represented their current situation.

  From pre-treatment to the 3rd month after treatment

Secondary Outcomes (1)

• Maximal interincisal opening (MIO)

  From pre-treatment to the 3rd month after treatment

Other Outcomes (1)

• TMJ sounds

  From pre-treatment to the 3rd month after treatment

Study Arms (2)

Combined Prolotherapy Group

EXPERIMENTAL

Patients with TMJ hypermobility underwent arthrocentesis for joint pain in addition to prolotherapy.

Drug: prolotherapy solution of 20% dextrose; Drug: Arthrocentesis with ringer solution

Traditional Prolotherapy Group

ACTIVE COMPARATOR

Prolotherapy was applied to patients with TMJ hypermobility.

Drug: prolotherapy solution of 20% dextrose

Interventions

prolotherapy solution of 20% dextrose DRUG

Polotherapy, it involves injecting an irritant solution into weakened joints, ligaments, or tendons to stimulate collagen production and tissue repair at fibro-osseous junctions.

Combined Prolotherapy Group; Traditional Prolotherapy Group

Arthrocentesis with ringer solution DRUG

Integrating arthrocentesis with prolotherapy may enhance therapeutic outcomes by addressing both the mechanical and inflammatory aspects of TMJ hypermobility. This dual-modality technique presents a promising minimally invasive option for clinicians managing patients with joint instability.

Combined Prolotherapy Group

Eligibility Criteria

• Age: 17 Years - 46 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University

Trabzon, Trabzon, 61040, Turkey (Türkiye)

Location

Related Publications (21)

• 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.

  PMID: 26846795 BACKGROUND

• 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.

  PMID: 33584052 BACKGROUND

• 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.

  PMID: 33326351 BACKGROUND

• 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.

  PMID: 29017019 BACKGROUND

• 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.

  PMID: 36523721 BACKGROUND

• 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.

  PMID: 19546260 BACKGROUND

• 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.

  PMID: 28460873 BACKGROUND

• 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.

  PMID: 39115583 BACKGROUND

• 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.

  PMID: 24064304 BACKGROUND

• 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.

  PMID: 23524704 BACKGROUND

• 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.

  PMID: 30024045 BACKGROUND

• 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.

  PMID: 19875361 BACKGROUND

• 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.

  PMID: 21703585 BACKGROUND

• 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.

  PMID: 1941330 BACKGROUND

• 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.

  PMID: 20188998 BACKGROUND

• 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.

  PMID: 29533255 BACKGROUND

• 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.

  PMID: 25806865 BACKGROUND

• 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.

  PMID: 28439165 BACKGROUND

• 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.

  PMID: 21757278 BACKGROUND

• 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.

  PMID: 22487806 BACKGROUND

• Ates H, Sivrikaya EC. Is the combine prolotherapy more effective than the traditional prolotherapy in patients with temporomandibular joint hypermobility? J Craniomaxillofac Surg. 2025 Dec;53(12):2238-2244. doi: 10.1016/j.jcms.2025.10.008. Epub 2025 Nov 3.

  PMID: 41188164 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Joint Instability; Joint Dislocations

Interventions

Glucose; Arthrocentesis; Ringer's Solution

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS

Model Details: The first group applied prolotherapy, while the other group applied arthrocentesis and prolotherapy together.

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 13, 2025
• Study Start: January 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2019-2022

Locations

TU (1)