Using hyaluronic acid injections to treat jaw pain in patients with temporomandibular issues: a clinical study

ISRCTN ISRCTN17693218
DOI https://doi.org/10.1186/ISRCTN17693218
Secondary identifying numbers ID042024
Submission date
21/10/2024
Registration date
22/10/2024
Last edited
22/10/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Temporomandibular disorders (TMDs) are issues with the jaw joint and surrounding muscles, causing pain and difficulty opening the mouth. One type of TMD, called disc displacement without reduction (DDwoR), occurs when the disc in the jaw joint is out of place and doesn't return to its normal position, leading to pain and limited mouth movement. This study aims to compare three treatments to find out which one is best at reducing pain and improving jaw function.

Who can participate?
Adults (both men and women) diagnosed with DDwoR who have not had success with other treatments can participate. Healthy volunteers cannot join this study.

What does the study involve?
The study compares four treatments:
- Injections of hyaluronic acid (HA) into the jaw joint
- A procedure called arthrocentesis (which washes out the joint)
- Arthrocentesis combined with HA injections
- Jaw exercises (used as the control group)

Participants will be randomly assigned to one of these groups. Their pain levels, jaw function, and quality of life will be measured at the start, after 1 month, and after 12 months.

What are the possible benefits and risks of participating?
Participants may experience reduced pain and improved jaw movement. Risks are minimal but may include temporary pain or swelling at the injection site after the procedures.

Where is the study run from?
The study is being conducted at Serviços Assistência Médico Social - Sindicato dos Bancários Sul e Ilhas (Portugal)

When is the study starting and how long is it expected to run for?
March 2018 to April 2024.

Who is funding the study?
The study is funded by Serviços Assistência Médico Social - Sindicato dos Bancários Sul e Ilhas and Qualylife Portugal.

who is the main contact?
André Mariz Coelho Santos de Almeida, andremarizalmeida@gmail.com

Contact information

Dr Andre AlmeIda
Public, Scientific, Principal Investigator

rua são tomas de aquino 18e 12esq
Lisboa
1600-871
Portugal

ORCiD logoORCID ID 0000-0002-4389-2825
Phone +351 914323985
Email aalmeida@egamoniz.edu.pt

Study information

Study designInterventional randomized controlled trial with parallel group design not blinded
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Dental clinic, Hospital
Study typeTreatment, Efficacy
Participant information sheet Not available in web format please use contact details to request a participant information sheet
Scientific titleEvaluation of viscosupplementation with hyaluronic acid in the treatment of refractory arthralgia in patients with disc displacement without reduction of the temporomandibular joint (TMJ): a randomized clinical trial
Study acronymEVHARCT
Study objectivesTo demonstrate that HA infiltration associated with mandibular manipulation is superior in terms of effectiveness to the combination of arthrocentesis with HA and mandibular manipulation, arthrocentesis alone and mandibular manipulation, and mandibular exercises in patients with disc displacement without reduction and refractory arthralgia in the TMJ.
Ethics approval(s)

Approved 09/10/2024, Ethics Commission of Hospital dos SAMS PICS do SBSI (Cidade de Gabela 1, Lisboa, 1849-017, Portugal; +351 218422000; Comissao.Etica@sams.pt), ref: ID04/2024

Health condition(s) or problem(s) studiedEvaluation of efficacy on the treatment of refratary articular pain in patients with disc displacement without reduction unilateral or bilateral
InterventionHyaluronic Acid (HA) Injection Group:
Participants in this group receive an injection of 1 ml of hyaluronic acid directly into the jaw joint (temporomandibular joint - TMJ). This treatment is believed to reduce friction in the joint, improve movement, and alleviate pain.

Arthrocentesis Group:
In this group, participants undergo arthrocentesis, which is a procedure that flushes the TMJ with saline solution to remove debris and reduce inflammation. This method aims to improve joint mobility and reduce pain.

Arthrocentesis with Hyaluronic Acid (HA) Group:
Participants in this group first undergo the arthrocentesis procedure (flushing the joint), followed by an injection of 1 ml of hyaluronic acid. The combination of both techniques is expected to provide enhanced pain relief and joint function compared to either method alone.

Jaw Exercises (Control Group):
Participants in this group are instructed on performing specific jaw exercises to improve their jaw movement and reduce pain. These exercises are done at home, with follow-up to ensure compliance. This group serves as a comparison to the minimally invasive treatments.

The patients in this study underwent two intervention sessions. The first intervention was administered after the initial consultation, and a second intervention was given 30 days later during a follow-up visit. After these interventions, patients were monitored through follow-up assessments conducted at 1 month and 12 months after the initial treatment to evaluate the long-term effects of the interventions on pain, jaw function, and overall quality of life.

At the time of treatment administration, participants were consecutively allocated (1:1:1:1) into treatment groups using a randomization tool prior to the procedures. The randomization process was handled by a technician who was not involved in any other procedures in the study. Opaque envelopes were used to ensure allocation concealment, and these envelopes were opened by the clinician immediately before administering the treatment. The order of the envelopes was determined independently before the study began by an investigator who was not involved in the study.
Intervention typeSupplement
Primary outcome measure1. Chronic pain Intensity value according to the Graded Chronic Pain Scale at baseline, 1 month and 12 months
2. Mandibular range of motion according to the DC/TMD measures of pain free opening and maximum unassisted opening at baseline, 1 month and 12 months
3. DC/TMD diagnosis change using the DC/TMD classification system at baseline, 1 month and 12 months
Secondary outcome measures1. Quality of life using the OHIP14 questionnaire at baseline, 1 month and 12 months
2. Jaw Functional Limitation using the Jaw functional limitation scale and the disability points according to the Graded Chronic Pain Scale at baseline, 1 month and 12 months
3. Overall TMJ pain assessment with the visual analogue score (VAS) at baseline, 1 month and 12 months after treatment
4. Overall Muscle pain assessment with the visual analogue score (VAS) at baseline, 1 month and 12 months after treatment
Overall study start date06/03/2018
Completion date01/04/2024

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexBoth
Target number of participants104
Total final enrolment97
Key inclusion criteria1. Both sexes
2. 18 to 70 years of age
3. Previous history of TMJ blocking
4. Acute or chronic temporomandibular disorder (TMD) uni- or bi-lateral
Key exclusion criteria1. Exclusively muscular TMD
2. Clinical history of TMJ fracture, ankylosis or surgery
3. Patients undergoing other kind of treatment for articular TMD
4. Fibromialgia
5. Preganancy
6. Patients who are blind, illiterate, or have reduced cognitive abilities that may interfere with communication, understanding of the study, response to questionnaires, or execution of instructions.
7. Known psychiatric or physical comorbidities that may interfere with communication or execution of instructions
Date of first enrolment03/06/2021
Date of final enrolment04/01/2023

Locations

Countries of recruitment

  • Portugal

Study participating centre

Serviços Assistência Médico Social - Sindicato dos Bancários Sul e Ilhas - SAMS centro clínico
R. Fialho de Almeida 21
Lisboa
1070-128
Portugal

Sponsor information

Facultad odontologia Universidad de Granada
University/education

Campus Universitario de Cartuja, s/n
Granada
18011
Spain

Phone +34 958244085
Email fjfernandez@ugr.es
Website https://www.ugr.es/universidad/organizacion/entidades/departamento-estomatologia
Serviços Assistência Médico Social - Sindicato dos Bancários Sul e Ilhas
Hospital/treatment centre

Rua Cidade de Gabela 1
Lisboa
1849-017
Portugal

Phone +351 218422000
Email Conselho.Executivo@sams.pt
Website https://www.sams.pt/Paginas/default.aspx
Egas
University/education

Campus Universitário, Quinta da Granja
Caparica
2829 - 511
Portugal

Phone +351 212946800
Email aalmeida@egamoniz.edu.pt
Website https://www.egasmoniz.com.pt/

Funders

Funder type

Hospital/treatment centre

Serviços Assistência Médico Social - Sindicato dos Bancários Sul e Ilhas

No information available

Qualylife Portugal

No information available

Results and Publications

Intention to publish date06/09/2025
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publicaton in a peer-reviewed journal
IPD sharing planThe datasets generated during and/or analyzed during the current study are not expected to be made available due to data protection policy from the hospital where the study was done

Editorial Notes

22/10/2024: Trial's existence confirmed by Ethics Commission of Hospital dos SAMS PICS do SBSI.