Assessment of Maximal Incisal Opening Using Patient Specific Titanium Eminoplasty Versus Inlay Autogenous Bone Graft for Treatment of Chronic Mandibular Condylar Dislocation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03728270|
Recruitment Status : Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Mandibular Condylar Dislocation||Device: Patient Specific Titanium Eminoplasty Procedure: Inlay Autogenous Bone Graft||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Assessment of Maximal Incisal Opening Using Patient Specific Titanium Eminoplasty Versus Inlay Autogenous Bone Graft for Treatment of Chronic Mandibular Condylar Dislocation|
|Estimated Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||February 1, 2020|
Experimental: Patient Specific Titanium Eminoplasty
Device: Patient Specific Titanium Eminoplasty
Active Comparator: Inlay Autogenous Bone Graft
Procedure: Inlay Autogenous Bone Graft
* Steps to harvest the bone graft:
- The maximal incisal opening [ Time Frame: 9 months ]will be measured using a caliper.