Class III Malocclusion Clinical Trial
Official title:
The Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Treated by Mandible-first Approach Versus Maxilla-first Approach; Randomized Controlled Clinical Trial
Verified date | October 2022 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigator will assess the inverted sequence approach in the treatment of class III patient undergoing bimaxillary orthognathic surgery
Status | Completed |
Enrollment | 24 |
Est. completion date | June 1, 2019 |
Est. primary completion date | January 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: 1. Patients with skeletal class III malocclusion requiring bimaxillary orthognathic surgery 2. Patients free from any systemic disease 3. Patients who approved to be included in the trial and signed the informed consent 4. Patients with no signs or symptoms of temporomandibular disorders. Exclusion Criteria: 1. Patients with cleft lip and palate "can have an unfavorable effect on facial growth (LARRY M. WOLFORD, 2002)" 2. Patients receiving chemotherapy or radiotherapy "due to the risk of low bone quality and healing (JW, 2003) " 3. Patients who refused to be included in the trial |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo University | Cairo | Middle East |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Ann HR, Jung YS, Lee KJ, Baik HS. Evaluation of stability after pre-orthodontic orthognathic surgery using cone-beam computed tomography: A comparison with conventional treatment. Korean J Orthod. 2016 Sep;46(5):301-9. doi: 10.4041/kjod.2016.46.5.301. Epub 2016 Sep 19. — View Citation
Béziat JL, Babic B, Ferreira S, Gleizal A. [Justification for the mandibular-maxillary order in bimaxillary osteotomy]. Rev Stomatol Chir Maxillofac. 2009 Dec;110(6):323-6. doi: 10.1016/j.stomax.2009.09.009. Epub 2009 Nov 25. French. — View Citation
Esteves LS, Castro V, Prado R, de Moraes e Silva CÁ, do Prado CJ, Trindade Neto AI. Assessment of skeletal stability after counterclockwise rotation of the maxillomandibular complex in patients with long-face pattern subjected to orthognathic surgery. J Craniofac Surg. 2014 Mar;25(2):432-6. doi: 10.1097/SCS.0000000000000395. — View Citation
Liebregts J, Baan F, de Koning M, Ongkosuwito E, Bergé S, Maal T, Xi T. Achievability of 3D planned bimaxillary osteotomies: maxilla-first versus mandible-first surgery. Sci Rep. 2017 Aug 24;7(1):9314. doi: 10.1038/s41598-017-09488-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the change in maxilla stability | to assess the change in maxillary stability on cone beam CT obtained immediately and 6 month postoperative.
the measuring unit is millimeter |
6 months | |
Secondary | Patient satisfaction | "the quality of life questionnaire" describes the patient's satisfaction during the entire treatment period which is done through a questionnaire answered by the patient through a score between 0-10 the measuring unit is numerical | 6 month |
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