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Unilateral TMJ Discectomy Without Interposal Material in Patients With Disc Perforation or Fragmentation

Primary Purpose

Temporomandibular Disorders

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
TMJ unilateral discectomy
Sponsored by
Instituto Portugues da Face
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorders focused on measuring Temporomandibular, TMJ Discectomy, TMJ Meniscectomy, TMJ Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age > 18 years old;
  • Unilateral TMJ pain >7 (0-10 VAS) and/or MMO < 30mm;
  • MRI presenting unilateral disc perforation or disc fragmentation
  • Clinical and imaging examination with criteria for unilateral TMJ discectomy

Exclusion Criteria:

  • Previous TMJ surgical intervention;
  • Concomitant contralateral surgery;
  • Age < 18 years old

Sites / Locations

  • Instituto Português da Face

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Discectomy

Arm Description

Unilateral Discectomy

Outcomes

Primary Outcome Measures

Pain (Visual Analogue Scale (0,10)
VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain
Pain (Visual Analogue Scale (0,10)
VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain

Secondary Outcome Measures

Maximum mouth opening (MMO, mm)
Mouth opening measured with a ruler (mm)
Maximum mouth opening (MMO, mm)
Mouth opening measured with a ruler (mm)
Muscle tenderness (0-3 scale)
0-3, corresponding to a muscle tenderness scale in masseter and temporalis muscle (0-whithout muscle tenderness, 3 - maximum muscle tenderness)
Muscle tenderness (0-3 scale)
0-3, corresponding to a muscle tenderness scale in masseter and temporalis muscle (0-whithout muscle tenderness, 3 - maximum muscle tenderness)

Full Information

First Posted
April 10, 2021
Last Updated
April 20, 2021
Sponsor
Instituto Portugues da Face
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1. Study Identification

Unique Protocol Identification Number
NCT04857294
Brief Title
Unilateral TMJ Discectomy Without Interposal Material in Patients With Disc Perforation or Fragmentation
Official Title
Unilateral TMJ Discectomy Without Interposal Material in Patients With Disc Perforation or Fragmentation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 9, 2015 (Actual)
Primary Completion Date
December 11, 2020 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Portugues da Face

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Temporomandibular joint (TMJ) discectomy is one of the most popular surgical techniques for painful TMJ. Previous studies have demonstrated predictable results of discectomy with optimal results in pain reduction and maximum mouth opening (MMO) improvement. However, those studies had most of the times varied inclusion criteria. A 4-year prospective study was designed including patients treated with unilateral TMJ discectomy without interposal material as the first surgical procedure for two specific intra-articular diagnosis: disc perforation and disc fragmentation.
Detailed Description
Temporomandibular disorders (TMD) are the most prevalent orofacial pain source of nondental origin. Those disorders can be due to a heterogeneous group of pathologies affecting the temporomandibular joint (TMJ), the jaw muscles, or both. TMD symptoms prevalence has been reported between 10 to 33% of the population. The most common symptoms include pain, joint sounds, limitation of mandibular movement, facial deformities, condyle dislocation and recurrent headaches. These symptoms can negatively affect the quality of life. Surgical treatments for TMD are reserved for specific cases, however with the popularization of mini-invasive surgical techniques such as TMJ arthroscopy, more patients have been eligible for these mini-invasive techniques, amplifying the scope of TMJ surgery. In diagnostics such as ankylosis, tumors and growth abnormalities, TMJ open surgery is strongly recommended. However, those diagnosis and relatively uncommon. TMJ internal derangement involving disc position/integrity and osteoarthrosis are more frequent, but the surgical indication is relative. From all the open surgery techniques, TMJ discectomy without interposal material is probably one of the most popular procedures. Recently, was showed that bilateral discectomy can induce severe TMJ changes detected with both imaging and histopathologic analysis in black Merino sheep. Besides, the critical histological and imaging results, functional masticatory alterations were not influenced by TMJ degenerative changes. Also, in other preclinical study, disc and fibrocartilage removal lead to traumatic TMJ ankylosis. It is interesting to observe the role of the condyle and temporal fibrocartilage, balancing the disc function. In humans, short-term studies on TMJ discectomy were associated with good results. In fact, in other retrospective study was showed discectomy without replacement is effective improving the preoperative maximum mouth opening (MMO). Despite the good clinical outcome, some studies have observed degenerative changes in imaging analysis. Together, clinical and preclinical results showed TMJ discectomy is a suboptimal technique, and an effective disc substitute, acting as a cushion between the condyle and temporal fossa could, in theory, improve these results. Despite extensive research in the field of tissue engineering, currently no appropriate disc substitute has demonstrated safety and efficacy. In fact, the last guidelines do not recommend disc replacement because nonvalid option showed superiority over discectomy alone. While there is no effective disc substitute, discectomy is often used when the disc is partial or total damaged and cannot be salvaged and/or and when symptoms fail to improve with other techniques. The inclusion criteria heterogeneity in previous studies, retrospective studies and non-randomization makes it difficult to draw clear conclusions about this technique. The investigators designed a rigorous prospective study for patients with: 1) unilateral TMJ disc perforation or 2) unilateral TMJ disc fragmentation. Those patients were proposed to unilateral TMJ discectomy. Most of the times, when the disc is damaged, the bone fibrocartilage is distorted and the authors wanted to understand the role of discectomy is those patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders
Keywords
Temporomandibular, TMJ Discectomy, TMJ Meniscectomy, TMJ Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Discectomy
Arm Type
Experimental
Arm Description
Unilateral Discectomy
Intervention Type
Procedure
Intervention Name(s)
TMJ unilateral discectomy
Intervention Description
All patients underwent general anesthesia with nasotracheal intubation, managed in most cases with intravenous anesthesia protocol, usually with remifentanil infusion. Intraoperative steroids, usually dexamethasone, were administered primarily to minimize postoperative swelling. A classic preauricular incision or a root of helix inter tragus notch incision (RHITNI) was used in most cases, as previously described. No bandage or special care was performed after the surgery. No air washing restrictions were recommended.
Primary Outcome Measure Information:
Title
Pain (Visual Analogue Scale (0,10)
Description
VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain
Time Frame
Pre-surgery
Title
Pain (Visual Analogue Scale (0,10)
Description
VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain
Time Frame
Through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Maximum mouth opening (MMO, mm)
Description
Mouth opening measured with a ruler (mm)
Time Frame
Pre-surgery
Title
Maximum mouth opening (MMO, mm)
Description
Mouth opening measured with a ruler (mm)
Time Frame
Through study completion, an average of 2 years
Title
Muscle tenderness (0-3 scale)
Description
0-3, corresponding to a muscle tenderness scale in masseter and temporalis muscle (0-whithout muscle tenderness, 3 - maximum muscle tenderness)
Time Frame
Pre-surgery
Title
Muscle tenderness (0-3 scale)
Description
0-3, corresponding to a muscle tenderness scale in masseter and temporalis muscle (0-whithout muscle tenderness, 3 - maximum muscle tenderness)
Time Frame
Through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age > 18 years old; Unilateral TMJ pain >7 (0-10 VAS) and/or MMO < 30mm; MRI presenting unilateral disc perforation or disc fragmentation Clinical and imaging examination with criteria for unilateral TMJ discectomy Exclusion Criteria: Previous TMJ surgical intervention; Concomitant contralateral surgery; Age < 18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ângelo, MD, PhD
Organizational Affiliation
Instituto Português da Face
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Português da Face
City
Lisboa
ZIP/Postal Code
1050-227
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No

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Unilateral TMJ Discectomy Without Interposal Material in Patients With Disc Perforation or Fragmentation

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