Effectiveness of Arthrocentesis and the Occlusal Splint in Treatment of the TMJ

NCT06256042 | Completed

• 1 other identifier: 50207321.8.0000.0068
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare occlusal splint and arthrocentesis in patients with disc displacement with/without reduction. The main question it aims to answer are: • Is there a more effective treatment for this cases? Participants will answer a questionary about pain and functional limitations. Researchers will compare Group 1(occlusal plate) and Gruoup 2 (arthrocentesis) to see if there is pain reduction and functional improvement in patients with disc displacement with/without reduction

Conditions

Temporomandibular Joint Disc Displacement; Anterior Disc Displacement

Keywords

Temporomandibular joint; Anterior disc displacement; Arthrocentesis; Interocclusal stabilizing splint.

Outcome Measures

Primary Outcomes (1)

• Jaw function available in mouth opening and moviments of jaw

  millimeter scale

  6 months

Secondary Outcomes (1)

• Pain available through of Visual Analogue Scale

  6 months

Study Arms (2)

Arthrocentesis

ACTIVE COMPARATOR

Delimitation of a corner-tragus line to mark points A (10mm in front of the tragus and 2mm below the CT line) and B (20mm in front of the tragus and 10mm below the CT line); Local intra- and extra-oral antisepsis with aqueous chlorhexidine 0.12% and 0.2%, respectively; Local anesthesia of the auriculotemporal and intra-capsular nerve with mepivacaine 2% + Epinephrine 1:100,000; Insertion of the first 30x0.8 mm needle at point A and injection of 2-3 mL of Lactated Ringer; Insert the second 30x0.8 mm needle into point B Wash with 100-200mL of Ringer Lactate; Removal of the second needle; Injection of 1mL of 20mg Triamcinolone diluted in 0.9% saline solution (1:1) through the needle at point A.

Procedure: Arthrocentesis

Occlusal splint

ACTIVE COMPARATOR

A stabilizing maxillary acrylic occlusal splint was made, flat, total and adjusted in central relation (RC).

Procedure: Occlusal splint

Interventions

Occlusal splint PROCEDURE

a stabilizing maxillary acrylic occlusal splint was made, flat, total and adjusted in central relation (RC).

Occlusal splint

Arthrocentesis PROCEDURE

The patient then underwent arthrocentesis of the temporomandibular joint itself, following the Nitzan technique.

Arthrocentesis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients at least 18 years old;
• Diagnosed with disc displacement with reduction with intermittent block or disc displacement without reduction;
• Availability of clinical follow-up for 6 months.

You may not qualify if:

• Pregnant patients;
• Patients undergoing conservative or invasive interventions to treat TMD in the last 6 months;
• Inability to use a stabilizing occlusal splint;
• Presence of toothache, neoplasms or medical contraindication for study participation.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of São Paulo Faculty of Medicine Clinics Hospital

São Paulo, 05.403-905, Brazil

Location

MeSH Terms

Interventions

Occlusal Splints; Arthrocentesis

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Oral and Maxillofacial Surgery Service

Model Details: Stabilizing interocclusal plate (IOP): a stabilizing maxillary acrylic occlusal plate was made, flat, total and adjusted in central relation (RC). Advice and guidance on the disease. Arthrocentesis: Delimitation of a corner-tragus line to mark points A (10mm in front of the tragus and 2mm below the CT line) and B (20mm in front of the tragus and 10mm below the CT line); Local intra- and extra-oral antisepsis with aqueous chlorhexidine 0.12% and 0.2%, respectively; Local anesthesia of the auriculotemporal and intra-capsular nerve with mepivacaine 2% + Epinephrine 1:100,000; Insertion of the first 30x0.8 mm needle at point A and injection of 2-3 mL of Lactated Ringer; Insert the second 30x0.8 mm needle into point B Wash with 100-200mL of Ringer Lactate; Removal of the second needle; Injection of 1mL of 20mg Triamcinolone diluted in 0.9% saline solution (1:1) through the needle at point A.

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 13, 2024
• Study Start: May 30, 2021
• Primary Completion: February 28, 2022
• Study Completion: January 15, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)