Clinical trial NCT03728270: Assessment of Maximal Incisal Opening Using Patient Specific Titanium Eminoplasty Versus Inlay Autogenous Bone Graft for Treatment of Chronic Mandibular Condylar Dislocation
Official title: Assessment of Maximal Incisal Opening Using Patient Specific Titanium Eminoplasty Versus Inlay Autogenous Bone Graft for Treatment of Chronic Mandibular Condylar Dislocation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Mandibular Condylar Dislocation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the small and highly specialized field of TMJ surgical treatments, restriction of the mandibular condylar movement outside of the articular eminence is one of the treatment choices suggested in TMJ dislocation.

Limitation of translation of the condyle in TMJ dislocation by inlay autogenous bone graft is the classic method to hinder the movement of the condyle beyond the articular eminence.

Patient specific TMJ prosthesis is very promising nowadays that it will not only build on the strengths of the current TMJ systems but will take advantage of digital innovations in custom design and three-dimensional(3D) printing of TMJ prosthesis. Moreover, TMJ Titanium eminoloplasty was reported to be a predictable and flexible instrument for TMJ dislocation treatment.

Thus, the investigators are conducting this study to compare the effect of both methods on the improvement of the maximal incisal opening of patients with chronic mandibular condylar dislocation, aiming to solve the problem of increasing the mouth opening of patients in their daily mouth opening. Also to reduce the community's fear from such a problem, which sometimes prevent patients from seeking treatment at their dentists leading to more serious complications that can be avoided. Furthermore, the investigators are trying to provide an evidence for oral and maxillofacial surgeons in order to provide the best quality service with the least expenses and thus gaining the patients' trust and saving time, money and effort.


Eligibility criteria: Inclusion Criteria:

* Medically free patients.
* Long-standing dislocation of the TMJ for more than 3 weeks and the failure of manual reduction.
* Failure of conservative strategies such as orientation to self-limit jaw movement and the use of a chin-cap or bandage.
* Previous failed TMJ surgery.
* Age range is between 18 and 40 years with no sex predilection.
* Patients who can understand Visual Analogue Scales (VAS) and are able to sign informed consent
* Highly motivated patients

Exclusion Criteria:

* Pregnant females.
* Patients having a significant systemic disorder.
* Psychological disorders, drug or alcohol dependency.
* Known allergies or sensitivities to dental materials, including Titanium or general anasethic agents.
* Severe medical conditions that would not allow management in the clinic.
* Inability to return for follow up visits.

Primary outcomes:
measure: The maximal incisal opening
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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