A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement (A Randomized Clinical Trial)
Phase: NA
Conditions: TMJ Disc Disorder
Sponsor: Alexandria University

 
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A COMPARATIVE STUDY BETWEEN THE DIFFERENT 
LEVELS OF TEMPOROMANDIBULAR JOINT ARTHROSCOPY 
IN THE MANAGEMENT OF TMJ INTERNAL DERANGEMENT  
(A RANDOMIZED CLINICAL TRIAL) 
02/02/2022 
 
ABSTRACT 
Introduction: Temporomandibular disorders (TMD) are common 
conditions with an estimated prevalence rate of 5 to 12% of populations, 
whereas only 3 to 4% of patients get suitable treatment.  Nowadays, 
minimally invasive arthroscopy has eliminated the use of many of the more 
complex surgical procedures. Numerous intra-articular operative 
arthroscopic techniques have been reported in the literature since the 
advent of temporomandibular joint (TMJ) arthroscopy. However, 
randomized controlled trials regarding outcomes are lacking nor are there 
strong evidence supporting one operative technique over another. 
Aim: to compare the three levels of TMJ arthroscopy in the management 
of temporomandibular joint internal derangement to develop standardized 
patient selection criteria and treatment options to be used by all 
investigators. 
Subjects: The study will be conducted on 30 patients with TMJ internal 
derangement (Wilkes III). Patients will be randomized into three groups: 
Group I: 10 patients will be treated with level (I) arthroscopy (Lysis and 
lavage). 
Group II: 10 patients will be treated with level (II) arthroscopy (operative 
arthroscopy). 
Group III: 10 patients will be treated with level (III) arthroscopy 
(operative arthroscopy + disc repositioning and fixation) 
Methods: All patients will be assessed clinically and radiologically by 
using MRI preoperatively to assess disc position. Then patients will be 
operated on randomly by either level. Then follow-up will be done for all 
patients for 6 months. 

 
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Results: Results will be tabulated and statistically analyzed. 
Keywords: TMJ arthroscopy, Internal derangement, Wilkes III, Arthroscopy 
levels, Arthroscopic discopexy, operative arthroscopy, Lysis and lavage. 
 
 

 
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INTRODUCTION 
The temporomandibular joint (TMJ) is the only diarthrodial  articulation 
of the human joints. It is known as ginglymo-arthrodial joint and is formed by 
the bony articulations of the mandibular condyle with the glenoid fossa of the 
temporal bone. Interposed between the condyle and the fossa is a piece of 
dense avascular fibrous connective tissue namely the TMJ disc. The disc 
divides the joint into superior and inferior compartments, which normally do 
not communicate with each other. The condyle and disc are in a normal 
anatomic relationship if the posterior band of the disc is located above the 
condylar head when the mandibular condyle is centrically positioned in the 
fossa.(1) 
The prevalence of temporomandibular disorders (TMD) is thought 
to be greater than 5% of the population. (2) Lipton and colleagues (3) showed 
that about 6% to 12% of the population experience clinical symptoms of 
TMD. Patients with TMD symptoms present over a broad age range; 
however, there is a peak occurrence between 20 and 40 years of age.(4) TMD 
symptoms are more prevalent in women than men. Women tend to develop 
TMD during their premenopausal years. The reasons behind the sexual 
disequilibrium in TMD prevalence are not entirely clear, but some have 
suggested a hormonal influence.(5-7) 
 

 
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Temporomandibular disorders (TMD) are a broad group of clinical 
problems involving the masticatory musculature, the temporomandibular joint, 
surrounding bony and soft tissue components, and combinations of these 
problems. Temporomandibular disorder (TMD) can result from any defect 
of one or both. Any problem that prevents this composite system of muscles, 
bones and joints from working in harmony may result in this disorder. 
Symptoms may be unilateral or bilateral and involve the face, head or jaw. The 
American Academy of Orofacial Pain (AAOP) classification divides TMD 
broadly into muscle related TMD (myogenous), and joint- related TMD 
(arthrogenous). The two types can be present at the same time, making 
diagnosis and treatment more challenging.(8) 
The etiology of temporomandibular disorders is multifactorial. It 
includes trauma (such as traumatic injuries from eating, wide jaw opening, 
and dental management), bruxism (refers to a non-functional grinding and 
clenching of the teeth), malocclusion (causes inappropriate pressure on the 
joint), Stress and psychiatric illness. TMD  is  clinically  characterized  by 
pain in the temporomandibular region or in the  muscles  of  mastication,  
pain radiating behind the eyes, in the face, shoulder,  neck and/or the  back, 
headaches, ear-ache or tinnitus, jaw clicking, locking or deviation, limited 
jaw opening, clenching or grinding of the teeth,  dizziness  and  sensitivity  
of  the teeth lacking oral disease. Pain is the most frequent symptom for 

 
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which patients seek medical attention.(8) 
Internal derangement of the temporomandibular joint (TMJ) is one of 
the most common temporomandibular disorders. In 1983, Dolwick (9) defined  
it as an abnormal relation between the temporomandibular disc with  respect  
to  the mandibular condyle, the temporal fossa, and the temporal eminence of 
the TMJ. Anterior disc displacement, with or without  reduction,  perforation  
of the retrodiscal tissue or the articular  disc,  and  degenerative  changes  of  
the disc and/or the joint surfaces, may be present. Clinically, it may be 
accompanied by pain, limitation of mouth opening, clicking, and locking.(10) 
In 1989, Wilkes (11) first established a classification to  correlate  clinical 
and radiological signs  with  surgical  findings.  The Wilkes classification 
consists of 5 stages based on clinical, radiologic, and intraoperative findings 
as follows: 
 

 
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Diagnosing TMD requires a focused history and physical examination. 
Pain and limited range of motion are accepted symptoms of TMJ dysfunction. 
In general, patients with true  intra-articular  pathology  have  pain  that  is 
localized to the involved  TMJ,  which is  increased  with mandibular movement  
or masticatory function. Failure to reproduce pain localized directly to the 
involved TMJ, stimulated with masticatory load and/or movement, is  a 
warning that the main cause of pain may not be intra-articular, even with 
magnetic resonance imaging (MRI) confirmed disc displacement. (12) 
Radiographic studies can also be used as supplemental diagnostic tools. 
Periapical radiographs can be used to rule out dental pathologies as a cause 
of referred pain. Cone beam computed tomography scans and panoramic 
radiographs will provide detailed imaging of the joint’s bony structures but 
not the articular disk. MRI is the modality of choice for examining the disk 
position and morphology (gold standard). MRI may also show degenerative 
bony changes. MRI findings should not alone dictate treatment strategies. One 
must combine patients’ clinical presentation, signs, and symptoms along with 
TMJ imaging when developing a treatment plan. The surgeon must treat the 
patient, not the MRI. Studies have revealed MRIs in asymptomatic subjects 
demonstrate disc displacement in the range of 32-38%.(12) On MRI, joint  
effusions are radiographic signs of inflammation and an important finding in 
true intra-articular pathology.(13) Inflammation indicates a transition from 
adaptive  to  pathologic  changes within the joint. The MRI diagnosis of 

 
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anterior disk displacement uses the most superior aspect of the condyle (12 
o’clock position) as a reference point. Anterior disk displacement is defined 
radiographically when the posterior disk tissue is located anterior to the 12-
o’clock condylar position. Disk displacement may occur in asymptomatic 
patients such that all radiographic findings must be placed in clinical context 
before beginning TMJ treatments.(14) 
Diagnostic arthroscopy provides the most important information 
determining the intra-articular surgery to be performed.  Arthroscopic 
diagnosis is based on visual inspection of the pathologic intra-articular tissues. 
The most common intra-articular pathologies are synovitis, adhesions, 
osteoarthritis, anterior disc position, disc perforation and inflamed synovial 
plicae. Less common intra-articular pathologies include synovial 
chondromatosis, pigmented villonodular synovitis, crystalline arthropathies 
and neoplasia.(15) 
Different methods have been proposed to treat this entity, beginning 
with conservative approaches. Occlusal splint therapy, medical treatment 
based on nonsteroidal anti-inflammatory drugs (NSAIDs) and muscle 
relaxants, and physical treatment are the most common options among 
conservative methods. Those refractory cases in which no effective 
improvement in terms of pain and mandibular function is obtained are 
amenable to further surgical treatment.(16) 

 
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Initially, surgical treatment for an internal derangement generally 
consisted of a discectomy, regardless of the type of internal derangement 
that was present.(17) However, in 1979, Farrar and McCarty (18)described 
surgical repositioning of the disc (discoplasty), showing that it was not 
necessary to remove the disc in most instances. Nevertheless, there were 
still instances where removal of the disc was necessary, because large, 
irreparable perforations, malformation of the disc, or calcification of the 
disc made it impossible to perform a discoplasty.(19) 
During the period when most surgeons were performing open surgical 
procedures for internal derangements of the TMJ, a small group of surgeons 
was beginning to experiment with arthroscopic surgery. First introduced by 
Ohnishi in 1975, this modality opened a new era in the diagnosis and 
treatment of such conditions.(20) 
Initially, arthroscopic treatment of patients with an internal 
derangement consisted mainly of lavage of the joint to remove tissue 
breakdown products and inflammatory cytokines and the lysis of any 
adhesions that were present. Eventually, other intra-articular surgical 
manipulations such as mechanical debridement, lateral capsular release, and 
disc repositioning and fixation by suturing or by electrocauterization, 
lasering, or sclerosis of the retrodiscal tissue were added.(19) 
Surgeons have described three levels of TMJ arthroscopy, Level I the 

 
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most basic, involving arthroscopic lysis and lavage (L&L) with diagnostic 
evaluation, Level II  (operative  arthroscopy)  involves  arthroscopic  lysis, 
lavage, needle working instrument used for operative maneuvers including 
visualized lysis of adhesions or targeted-tissue medication injections, lateral 
pterygoid myotomy or botulinum toxin injection and retrodiscal coagulation. 
Level III includes more advanced procedures, double punctures, triangulation 
and visualized intraoperative maneuvers, including removal of pathology, 
debridement, motorized shaving, synovial biopsies, disc mobilization or disc 
repositioning with stabilization (discopexy) either by sutures or a resorbable 
pin.(15) 
According to Al-Moraissi et al, on the hierarchy of different treatments 
for arthrogenous TMDs, they concluded that there is new evidence that  
minimally  invasive procedures are significantly more effective than 
conservative  treatments for both pain reduction and improvement of 
maximal interincisal opening (MIO). In contrast to traditional concepts 
mandating exhaustion of conservative treatment options, minimally invasive 
procedures, therefore, deserve to be implemented rather early, i.e., as soon as 
patients do not show a clear benefit from an initial conservative treatment.(21)  
According to Santana Santos et al, comparing the effectiveness of 
open discopexy versus arthroscopic techniques, the available evidence 
showed an overall decrease in pain score and an improvement in mouth 

 
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opening after TMJ surgeries with discopexy. Changes in the (MIO) were 
greater after arthroscopic disk repositioning compared to the open-joint 
procedure.(22) 
Nowadays, minimally invasive surgery has become the 1st choice as 
it is a quick procedure, less postoperative complications, short hospital 
stay, early rehabilitation, and return to work.(23) 
According to Murakami on the rationale of arthroscopic surgery of 
the TMJ, he stated that, although various arthroscopic disc repositioning 
and suturing techniques were reported, the success rate was comparable to 
arthroscopic lysis and lavage, and the documentation by postoperative 
imaging was insufficient.(24) 
According to Israel: Numerous intra-articular operative arthroscopic 
techniques have been reported in the literature since the advent of 
temporomandibular joint (TMJ) arthroscopy. However, Ideal randomized 
controlled trials regarding outcomes are lacking nor are their strong 
evidence supporting one operative technique over another.(15) 
Nowadays, minimally invasive procedures have eliminated the use of 
many of the more complex surgical procedures. Despite such advancements, 
however, clinicians are still encountering some difficulty in successfully 
treating many of these patients and finding the answers to these problems will 

 
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depend on future developments. 
A review of the literature reveals that there is lack of randomized clinical 
trials to compare between the three levels of TMJ arthroscopy in the 
management of TMJ internal derangement.  
The null hypothesis states that there will be no significant difference 
between the three levels of TMJ arthroscopy. Consequently, by doing the 
necessary studies and comparing the results, we can accept or reject this 
theory to finally develop guidelines and standardized patient selection criteria 
that can be followed by all researchers. 
 
 
 

 
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AIM OF THE STUDY 
To compare between the three levels of TMJ arthroscopy in the 
management of TMJ internal derangement in the following points: 
Primary aims are to assess: 
1. Pain score using the visual analog score (VAS).(25) 
2. Presence or absence of clicking. 
3. Mouth opening measuring the maximal interincisal opening in MIS. 
4. Lateral excursion movement. 
5. Protrusive movement. 
Secondary aims are to assess: 
1.Operative time. 
2.Post operative MRI (disc position). 
 

 
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Assessed for eligibility (n=30) 
Excluded  (n=   ) 
   Not meeting inclusion criteria (n=  ) 
   Declined to participate (n=  ) 
   Other reasons (n=  ) 
Analysed  (n=  ) 
 Excluded from analysis 
(give reasons) (n=  ) 
Lost to follow-up (give 
reasons) (n=10) 
Pain 
MIO 
MRI 
Allocated to intervention (n= 
10) 
 Level I Arthroscopy 
Allocation 
Analysis 
Follow-Up 
Randomized (n=30) 
Enrollment
Allocated to intervention (n= 
10) 
 Level II Arthroscopy 
Allocated to intervention (n= 
10) 
 Level III Arthroscopy 
 
Lost to follow-up (give 
reasons) (n=10) 
Pain 
MIO 
MRI 
Lost to follow-up (give 
reasons) (n=10) 
Pain 
MIO 
MRI 
Analysed  (n=  ) 
 Excluded from analysis 
(give reasons) (n=  ) 
Analysed  (n=  ) 
 Excluded from analysis 
(give reasons) (n=  ) 

 
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Study design 
This study will be a randomized controlled clinical trial, with 1:1:1 ratio 
and will be reported according to CONSORT guidelines (26) 
PICO Question 
Do patients with TMJ internal derangement treated with arthroscopy level 
I compared to arthroscopy level II or arthroscopy level III show better 
maximal interincisal opening and less pain?  
Settings and Location: 
Participants will be selected from the Maxillofacial and Plastic Surgery 
Department, Faculty of Dentistry, Alexandria University, Egypt.  
Sample size calculation 
The size was estimated based on 5% alpha error and 80% study power. The 
mean (SD) improvement in Maximum Interincisal Opening (MIO) after 6 
months compared to the preoperative measurements was 6.09 (7.05) mm 
for Level I arthroscopy, (10) 6.7 (5.25) mm for Level II arthroscopy, (27) 
and 18.5 (2.1) mm for Level III arthroscopy. (28) Based on difference 
between independent means using F test and pooled SD = 4.8 mm, the 
minimum sample size was calculated to be 9 joints per group, increased to 
10 joints to make up for lost to follow up cases. Total sample = number per 
group x number of groups = 10 x 3 = 30 joints. Sample size was based on 
Rosner’s method (29) calculated by G*Power 3.1.9.7. (30) 
 

 
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Randomization  
Participants will be randomly assigned using online program 
(www.random.org) in order to allocate participants to the group. 
Allocation Concealment 
Sequentially numbered opaque sealed envelopes will be used to conceal 
allocation. One set of envelops will be created to guarantee they were 
opaque, sealed and sequentially numbered.  
Blinding 
The patients will be blinded to the treatment group. 
Intervention 
Group I: 10 patients will be treated with level (I) arthroscopy (Lysis and 
lavage). 
Group II: 10 patients will be treated with level (II) arthroscopy (operative 
arthroscopy). 
Group III: 10 patients will be treated with level (III) arthroscopy 
(operative arthroscopy + disc repositioning and fixation). 
Eligibility Criteria 
Inclusion criteria 
The patients with TMJ internal derangement will be divided into   5 stages 
according to Wilkes Classification. (11) Only patients with stage III will be 

 
16 
 
included in this study. 
Exclusion criteria 
1. Medically unfit patients. 
2. Patients with TMDs secondary to malocclusion.  
3. Psychological instability. 
4. Patients operated before for other TMJ problems. 

 
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Materials 
In all procedures, 1.9 mm, 30-degree optical device, sleeves, sharp and 
blunt trocars, adhesion knives, an exploratory probe, a bipolar electrode 
(Karl Storz Endoscopy, Tuttlingen, Germany) and coblator. 
A specific material for pin placement is A third custom-made cannula 
(2.7mmdiameter) with a distal parallel double window (10 _ 2 mm) for direct 
view control of pin fixation, a long 1.5-mm rotatory drill  for perforating disc 
and condyle, and an impactor with hammer (fixation kit). 
Resorbable 
pins are Smart Nail (ConMed, 
Linvatec, Tampere, 
Finland),1.5mm_ 16mmsize (head of pin 2.5mmin diameter and  flange  of  1 
mm) and manufactured of polylactic acid copolymer (Self-Reinforced 96L/4D 
PLA). The mean degradation period was standardized between 18 and 26 
months. (31) 

 
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Pre-surgical evaluation 
All   patientswill   be subjected to full history taking, full clinical 
examination and investigations including preoperative MRI and Panoramic 
x-ray to assess the dental condition. 
Surgical technique  
1- All procedures will be done under general anesthesia (nasotracheal 
intubation). 
2- The triple-channel arthroscopic technique of McCain et al is 
used(32) 
After the first puncture of the fossa, a systematic diagnostic 
arthroscopy is carried out. A second puncture is carried out aiming at the 
anterior recess under direct arthroscopic visualization (Level I). 
3- Anterior release: (Level II) 
Through the working cannula additional local anesthesia is injected 
to avoid post-operative pain and to decrease bleeding; it can also reduce 
the risk of masticatory muscle nerve injury. A Knife, coblation or laser 
probe are used to cut the anterior attachment of the disc and the neighboring 
part of the lateral pterygoid muscle. The incision line is located 
approximately 2–3 mm anterior to the anterior band of the disc and is 

 
19 
 
carried  out across the whole width from medial to lateral. The depth of the 
anterior release is no more than 2 mm to avoid breaking large blood vessels 
and damaging the masticatory muscle nerve in the anteromedial synovium.  
5- Retrodiscal scarification or contracture 
Retrodiscal tissue is contracted using bipolar cautery, laser, or 
coblation. The target area of the retrodiscal contracture is generally the 
boggy and redundant synovium found lateral to the oblique protuberance. 
Contracture is visible during the procedure, but the most significant 
contracture occurs 2 to 3 weeks postoperatively as the scar thickens. The 
purpose of the contracture is to enhance the posterior positioning of the 
disc and hold it there. The posterior synovectomy and the scar contracture 
are also done to reduce volume of the joint space so the disc can sit more 
posteriorly. 
6- Disc reduction 
After the anterior release is completed, the obturator is positioned at 
the anterior margin of the disc and the disc is pushed backwards. The 
obturator slides along the surface of the disc and arrives in the 
posterolateral recess. The retrodiscal tissue is pushed down inferiorly and 
posteriorly. 
 

 
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7- Disc fixation: (Level III) 
A disc fixation can be accomplished in 1 of 2 ways. The first and more 
traditional way is the suture discopexy. A second way is by rigid fixation with 
either resorbable or titanium screws. Regardless of the methodology of 
fixation, the disc is held in reduction during the course of the fixation.  The 
target area of fixation is the posterior lateral corner of the disc-condyle 
assembly, the area of the lateral pole where the disc attaches to the condyle.  
Postoperative management 
Antibiotics and nonsteroidal anti-inflammatory drugs are routinely 
prescribed for 5 days. The softness of the postoperative diet should be 
decreased slowly. Exercises to improve mouth opening are explained to the 
patient and start 1 week after operation. 
In patients with significant postoperative occlusal changes, a splint is 
recommended. It is designed to raise the bite and prevent contact between 
upper and lower incisors and canines.  Due to the resulting distalization of the 
bite force, joint loading is reduced, which contributes to the joint's 
rehabilitation. The appliance should be left in place around the clock during 
the first ten postoperative days, then used at night for four additional weeks.(34) 
Follow up  
• Pain assessment using VAS (Visual Analogue Scale) (25)  

 
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• Clicking (improvement or persistence). 
• Range of motion (33) including: maximal interincisal opening, lateral 
excursion movement and Protrusive movement 
• Post-operative MRI at 6 months for detection of disc position. 
• All patients will be followed up at 1, 3, 6 months. 
 

 
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ETHICAL CONSIDERATIONS 
Research Ethics Committee approval 
The research protocol will be approved by the Research Ethics 
Committee of Alexandria University Faculty of Dentistry (IRB No. 001056 
– IORG 0008839) prior to any research-related activities 
All research activities involving human subjects will abide with the 
Declaration of Helsinki (34) and other ethical guidelines adopted by the 
Research Ethics Committee of Alexandria University Faculty of Dentistry. 
The benefits to the participant and/or the community 
1. Treatment of patients with internal derangement with minimally 
invasive surgery (TMJ arthroscopy). 
2. Short hospital stay with early recovery and rapid return to work. 
The risks to the participant and/or the community 
1. The need for long-term follow-up postoperative. 
2. The exposure to radiation in MRI which is needed for follow-up at 6 
months. 
Anonymity and Confidentiality 
The anonymity and confidentiality of the participants will be 
preserved by not revealing their names and identity in the data collection, 
analysis and reporting of the study findings. 
The identity of participants will be kept confidential or anonymous 
and the assurances extend beyond protecting their names to also include 
the avoidance of using self-identifying statements and information. 
 
 
 

 
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DATA MANAGEMENT & STATISTICAL ANALYSIS 
Data will be collected and analyzed statistically using ANOVA test to 
compare between the three groups. 
 

 
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Celić R, Jerolimov V, Knezović Zlatarić D, Klaić B. Measurement of 
mandibular movements in patients with temporomandibular disorders and in 
asymptomatic subjects. Coll Antropol. 2003;27 Suppl 2:43-9. 
34. 
World Medical Association Declaration of Helsinki: ethical principles 
for medical research involving human subjects. Jama. 2013;310(20):2191-4. 
 
 
 
 
 
 
 

 
27 
 
Informed Consent 
 
 
Research 
Title:
 
A comparative study between the different levels of tmj 
arthroscopy in the management of tmj internal 
derangement (a randomized clinical trial)
 
Research 
Steps:
 
- 
This study is conducted in Maxillofacial and Plastic Surgery 
Department, Faculty of Dentistry, Alexandria University on 
patients having temporomandibular joint internal derangement 
Wilke’s III. 
- 
All patients will be assessed clinically and radiologically by 
using MRI preoperatively to assess disc position. 
- 
Patients will be randomized into three groups: 
o Group I: 10 patients will be treated with level (I) 
arthroscopy (Lysis and lavage). 
o Group II: 10 patients will be treated with level (II) 
arthroscopy (operative arthroscopy). 
o Group III: 10 patients will be treated with level (III) 
arthroscopy (operative arthroscopy + disc repositioning 
and fixation)  
Research 
duration:
From June 2021 to July 2023 
Research 
place:
Maxillofacial and Plastic Surgery Department, Faculty of Dentistry, 
Alexandria University 
Research 
Benefits:
To compare between the three levels of TMJ arthroscopy in the 
management of temporomandibular joint internal derangement to 
develop standardized patient selection criteria and treatment options 
to be used by all investigators 
Side 
No expected harmful  side effects of the research

 
28 
 
effects:
I, the undersigned, acknowledge that the researcher informed me that: 
1 - The research does not contradict the values and ethics of society. 
2 - With an emphasis on the confidentiality of the research and my right to leave it without 
being held accountable and without affecting medical care 
Name of the participating patient................................ Signature of the participating patient 
(guardian)........ .................
........ 
Principal researcher's signature..Mohamed Hamza Fayad.................................. 
 
 
 

 
29