Chitosan-Hyaluronate Gel Mixture Vs Hyaluronic for Internal Derangement

TMJ Disc Disorder Clinical Trial

— TMJ  

Official title:

Arthroscope-Guided Intra-Articular Injection of Chitosan-Hyaluronate Gel Mixture Versus Hyaluronic Acid in the Treatment of TMJ Internal Derangement: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06426199
• Other study ID #: 12345asdfg
• Status: Recruiting
• Phase: Phase 4
• Start date: January 17, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: Nehal IA Shobair, PhD
• Phone: 00201063666985
• Email: nehal.shobair[@]miuegypt.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to assess the impact of injecting sodium hyaluronic acid versus a chitosan-hyaluronate hybrid gel into the upper compartment of the temporomandibular joint (TMJ) as a treatment for anterior disc displacement without reduction. The study will include patients diagnosed with Stage III or IV TMJ internal derangement (anterior disc displacement without reduction), as classified by Wilkes, with diagnoses confirmed through clinical symptoms and MRI evaluations. Participants will be randomly divided into two groups, both undergoing TMJ arthroscopy. In the first group, 2 ml of chitosan-hyaluronic acid hybrid gel will be injected into the affected joints, whereas in the second group, 2 ml of hyaluronic acid (HA) will be administered. The study will compare and analyze outcomes in both groups, focusing on pain during TMJ function, clicking sounds, the extent of maximum mouth opening, and maximum lateral jaw movement.

Description:

This study will be a prospective randomized controlled clinical study on a convenience sample of patients who will be selected from the Department of Oral and Maxillofacial Surgery, Faculty of Dental Medicine, Suez University. Patients selected are whom will be diagnosed with TMJ internal derangement (anterior disk displacement without reduction Stage III, Stage IV Wilkes classification) based on clinical symptoms and MRI evaluations. Inclusion criteria will be adults aged between 25 - 50 years old, sufficient clinical and magnetic resonance imaging (MRI) data that could be obtained before and after the treatment. The exclusion criteria will be hematological or neurological diseases, inflammation or connective tissue diseases, head and neck malignancies, history of treatment of TMJ disease or history of craniofacial surgery not related to internal derangement treatment, insufficient clinical and MRI data.

Participants will be selected based on established criteria. A total sample size of 20 (10 in each group) was calculated to detect an effect size of about 1.33-1.34, with a power (1-β error) of 0.8 (80%) using a two-sided hypothesis test, with a significance level (α error) 0.05 for data [13]. All patients will undergo a preoperative clinical evaluation including Pain level on forced mouth opening using visual analogue scale (VAS), assessment of mean lateral jaw movements, assessment of TMJ clicking, assessment of maximum mouth opening (MMO), deviation of mandibular midline during mouth opening and closure. All patients will do a Magnetic resonance imaging (MRI) to evaluate the disc displacement.All patients will undergo conservative treatment as the first line of treatment in all TMJID cases. All patients will be under general anesthesia.

For both groups, the operation will be under GA and The skin surface of the pre-auricular region will be disinfected with povidone iodine solution. For both groups, TMJ arthroscopy will performed by the same TMJ arthroscopy surgeon. Lysis and lavage will be performed in the upper joint space in all cases based on the triangulation technique with an inferolateral approach. The arthroscopic procedure will include lysis of adhesions, lavage, manipulation, and debridement of the upper joint space. A 1.9-mm arthroscope with a video monitoring and recording system and a 2.2-mm protective cannula sheath will be used for TMJ arthroscopy. Ringer's lactate will be used as irrigation fluid. Both groups will receive the same arthroscopic treatments. In the first group, the injection of 2 ml of chitosan-hyaluronic acid hybrid gel into affected joints, while 2 ml of HA will be injected in to affected joints in the second group. Needles will be removed after the injection sites and covered its sites with gauze dressing. Postoperative care and instructions:

1. Medications:

Brufen* as a nonsteroidal anti-inflammatory drug (NSAIDs) relieving muscle pain and swelling. Myofen* as a muscle relaxant especially for people who grind or clench their teeth help to relax tight jaw muscles.

2. Application hot & cold packs:

All patients will be instructed to apply an ice pack to the side of his face and temple area for about 10 minutes. Also, simple stretching exercises for his or her jaw should be done. Application a warm towel or pack to the side of his face for about 5 minutes five times daily for 4 days.

3. Soft diet:

Soft food such as yogurt, mashed potatoes, cheese, soup, fish, cooked fruits and vegetables, beans, and grains should be eaten. In addition, food should be cut into small pieces. Avoid hard and crunchy foods like hard rolls, raw carrots, thick and large foods that need your mouth to open wide to fit the foods. Also, chewy sticky foods (like caramels and taffy) avoided too for next 10 days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Patients were diagnosed with TMJ internal derangement (anterior disk displacement without reduction Stage III, Stage IV Wilkes classification) based on clinical symptoms and MRI evaluations.

2. Age 25 - 50 years old.

Exclusion Criteria:

1. Hematological or neurological diseases.

2. Inflammation or connective tissue diseases.

3. Head and neck malignancies.

4. History of treatment of TMJ disease or history of craniofacial surgery not related to ID treatment.

5. Insufficient clinical and MRI data.

Related Conditions & MeSH terms

• TMJ Disc Disorder

Intervention

Drug:
• Chitosan-Hyaluronate Gel Mixture
The operation will be under GA. TMJ arthroscopy will performed by the same TMJ arthroscopy surgeon. Lysis and lavage will be performed in the upper joint space in all cases based on the triangulation technique with an inferolateral approach. The arthroscopic procedure will include lysis of adhesions, lavage, manipulation, and debridement of the upper joint space. A 1.9-mm arthroscope with a video monitoring and recording system and a 2.2-mm protective cannula sheath will be used for TMJ arthroscopy. Ringer's lactate will be used as irrigation fluid. Both groups will receive the same arthroscopic treatments. The injection of 2 ml of Chitosan-Hyaluronate Gel Mixture into affected joints will be performed. Needles will be removed after the injection sites and covered its sites with gauze dressing.
• Hyaluronic Acid
The operation will be under GA. TMJ arthroscopy will performed by the same TMJ arthroscopy surgeon. Lysis and lavage will be performed in the upper joint space in all cases based on the triangulation technique with an inferolateral approach. The arthroscopic procedure will include lysis of adhesions, lavage, manipulation, and debridement of the upper joint space. A 1.9-mm arthroscope with a video monitoring and recording system and a 2.2-mm protective cannula sheath will be used for TMJ arthroscopy. Ringer's lactate will be used as irrigation fluid. Both groups will receive the same arthroscopic treatments. The injection of 2 ml of Hyaluronic acid into affected joints will be performed. Needles will be removed after the injection sites and covered its sites with gauze dressing.

Locations

Country	Name	City	State
Egypt	Suez University	Suez

Sponsors (3)

Lead Sponsor	Collaborator
Ain Shams University	Misr International University, University of Nizwa

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Joint Pain	Self-pain and function of the jaw assessment, with Visual Analogue Scale (VAS), ranging from 0 to 10 scales. This scale will be used for self-evaluation of the patients, to evaluate pain level and jaw dysfunction and compared with preoperative degree. Patients will be asked about the pain severity & dysfunction according to the VAS.	3 months
Primary	lateral excursion	Maximum lateral excursion, the distance from midline of upper & lower jaw will be measured with a digital caliper in mm.	3 months
Primary	TMJ sounds	measured by asking the patients to open and closed his mouth several times and clicking was recorded as present (early clicking, late clicking) or absent.	3 months
Primary	Maximum mouth opening	Maximum mouth opening (MMO), between upper & lower incisors will be measured during maximum opening with a digital caliber in mm.	3 months