Assessment of Maximal Incisal Opening Using Patient Specific Titanium Eminoplasty Versus Inlay Autogenous Bone Graft for Treatment of Chronic Mandibular Condylar Dislocation

Chronic Mandibular Condylar Dislocation Clinical Trial

Official title:

Assessment of Maximal Incisal Opening Using Patient Specific Titanium Eminoplasty Versus Inlay Autogenous Bone Graft for Treatment of Chronic Mandibular Condylar Dislocation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03728270
• Other study ID #: 33377576
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: February 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Mandibular Condylar Dislocation

Intervention

Device:
• Patient Specific Titanium Eminoplasty
The stages of virtual surgical planning and fabrication of patient specific titanium eminoplasty will be designed my Mimics 15 program. Once designed, the virtual design and surgery will be planned on a computer model where vital anatomical structures could be identified and thus could be avoided during surgery. After obtaining all the dataset needed from the CT scan, the collected data will be sent to the Egyptian soil, water and environmental institution for manufacturing, packing and sterilization of the patient specific titanium eminence. The patient specific titanium eminence will be inserted and secured with two to three screws of individual lengths according to the virtual plan. Functional mandibular movements were reproduced to confirm absence of subluxation and checked for interference and any required adjustments made. A multilayer closure of the incisions will be accomplished using Vicryl

Procedure:
• Inlay Autogenous Bone Graft
* Steps to harvest the bone graft: Down-fracture of the articular eminence to be augmented with Inlay bone graft to increase the vertical height of the articular eminence. A green-stick fracture will be created avoiding a possible complete fracture of the lower segment of the eminence To obtain Inlay bone graft from the chin, anterior mandibular vestibule incision will provide good access to the mandibular symphysis.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximal incisal opening	will be measured using a caliper.	9 months