Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426199
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-12
Brief Title:
Chitosan-Hyaluronate Gel Mixture Vs Hyaluronic for Internal Derangement
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TMJ
Brief 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
Detailed 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 133-134 with a power 1-β error of 08 80 using a two-sided hypothesis test with a significance level α error 005 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 displacementAll 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 19-mm arthroscope with a video monitoring and recording system and a 22-mm protective cannula sheath will be used for TMJ arthroscopy Ringers 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
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 133-134 with a power 1-β error of 08 80 using a two-sided hypothesis test with a significance level α error 005 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 displacementAll 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 19-mm arthroscope with a video monitoring and recording system and a 22-mm protective cannula sheath will be used for TMJ arthroscopy Ringers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None