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

NCT03728270 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-11-02

No results posted yet for this study

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.

Conditions

  • Chronic Mandibular Condylar Dislocation

Interventions

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2019-12-01
Completion
2020-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03728270 on ClinicalTrials.gov