Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2026-01-01 @ 12:06 PM
Study NCT ID:
NCT05938257
Status:
UNKNOWN
Last Update Posted:
2023-07-10
First Post:
2023-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study Between Arthroscopic Versus Open Surgical Discopexy for Treatment of Temporomandibular Joint Anterior Disc Displacement Without Reduction (RCT)
Sponsor:
Mohamed Gamal Thabet
Organization:
Study Overview
Official Title:
Comparative Study Between Arthroscopic Versus Open Surgical Discopexy for Treatment of Temporomandibular Joint Anterior Disc Displacement Without Reduction (RCT)
Status:
UNKNOWN
Status Verified Date:
2023-07
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Temporomandibular joint dysfunction (TMD) represents a common health problem. A recent systematic review and meta-analysis in 2021 concluded that the prevalence of TMD was 31% for adults and 11% for adolescence.
Many believe that TMD symptoms are related to internal derangement of the temporomandibular joint (TMJ), which is usually in the form of anterior disc displacement(ADD) and it is often associated with pain, clicking, limited range of motion, and even osteoarthritic changes.
Treatment of TMD include non-surgical and surgical modalities. Non-surgical treatment includes instructions, pharmacotherapy, occlusal splints and physiotherapy. Patients who do not respond to non-surgical therapy may require surgical interventions that include minimally invasive procedures (arthroscopy and arthrocentesis) and open surgery.
Arthroscopy of the TMJ was first introduced by Ohnishi in 1975, it involves lysis of adhesions and lavage of the superior joint space, as well as repositioning of a displaced disc.
Open TMJ surgery can be very effective at eliminating symptoms of pain, limited mouth opening and mandibular dysfunction.
Many believe that TMD symptoms are related to internal derangement of the temporomandibular joint (TMJ), which is usually in the form of anterior disc displacement(ADD) and it is often associated with pain, clicking, limited range of motion, and even osteoarthritic changes.
Treatment of TMD include non-surgical and surgical modalities. Non-surgical treatment includes instructions, pharmacotherapy, occlusal splints and physiotherapy. Patients who do not respond to non-surgical therapy may require surgical interventions that include minimally invasive procedures (arthroscopy and arthrocentesis) and open surgery.
Arthroscopy of the TMJ was first introduced by Ohnishi in 1975, it involves lysis of adhesions and lavage of the superior joint space, as well as repositioning of a displaced disc.
Open TMJ surgery can be very effective at eliminating symptoms of pain, limited mouth opening and mandibular dysfunction.
Detailed Description:
Patients are assigned randomly into two groups; group (1) for arthroscopic discopexy, and group (2) for open discopexy.
History taking: personal history; name, age, gender and occupation. Patient's complaint(s); as TMJ clicking, pain, locking and limited mouth opening.
Clinical examination: for TMJ clicking and tenderness, measurement of maximum inter-incisal opening (MIO) in mm. Examination of facial symmetry, dental occlusion and dentoskeletal deformity.
Radiological evaluation: Computed Tomography (CT) scan of maxillofacial bones. Magnetic Resonance Imaging (MRI) for TMJ, to confirm anterior disc displacement without reduction.
Operative procedures: will be carried out by the same team, under general anaesthesia, nasotracheal intubation and supine position.
Group (1) for arthroscopic discopexy: using 1.9 mm diameter - 30-degree scope. The procedure is performed through three ports and a suture-passing spinal needle 18 gauge. One port for the scope, second port for manipulation and reduction of the displaced disc and third port for retrieval of the suture used for discopexy. The suture used is 2-0 polypropylene, which is tied down in the extra-capsular tissue.
Group (2) for open discopexy: through pre-auricular incision. Exposure of the temporomandibular joint capsule, incision is made through the lateral capsule into the superior joint space and the disc is repositioned. Discopexy is done using 2-0 polypropylene suture.
Follow up will be at intervals of 1, 3, 6 and 12 months after the operation for clinical assessment of pain by Visual Analogue Scale (VAS), MIO in mm, joint clicking and complications.
MRI of TMJ is performed after one month of surgery to evaluate position of the articular disc.
History taking: personal history; name, age, gender and occupation. Patient's complaint(s); as TMJ clicking, pain, locking and limited mouth opening.
Clinical examination: for TMJ clicking and tenderness, measurement of maximum inter-incisal opening (MIO) in mm. Examination of facial symmetry, dental occlusion and dentoskeletal deformity.
Radiological evaluation: Computed Tomography (CT) scan of maxillofacial bones. Magnetic Resonance Imaging (MRI) for TMJ, to confirm anterior disc displacement without reduction.
Operative procedures: will be carried out by the same team, under general anaesthesia, nasotracheal intubation and supine position.
Group (1) for arthroscopic discopexy: using 1.9 mm diameter - 30-degree scope. The procedure is performed through three ports and a suture-passing spinal needle 18 gauge. One port for the scope, second port for manipulation and reduction of the displaced disc and third port for retrieval of the suture used for discopexy. The suture used is 2-0 polypropylene, which is tied down in the extra-capsular tissue.
Group (2) for open discopexy: through pre-auricular incision. Exposure of the temporomandibular joint capsule, incision is made through the lateral capsule into the superior joint space and the disc is repositioned. Discopexy is done using 2-0 polypropylene suture.
Follow up will be at intervals of 1, 3, 6 and 12 months after the operation for clinical assessment of pain by Visual Analogue Scale (VAS), MIO in mm, joint clicking and complications.
MRI of TMJ is performed after one month of surgery to evaluate position of the articular disc.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: