Clinical trial NCT03353116: Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Using the Inverted Sequence Approach
Official title: The Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Treated by Mandible-first Approach Versus Maxilla-first Approach; Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class III Malocclusion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 24
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigator will assess the inverted sequence approach in the treatment of class III patient undergoing bimaxillary orthognathic surgery

Detailed description: The investigator will compare the maxillary stability in class III orthognathic patients undergoing bimaxillary surgery by two surgical approaches ; the mandible-first (intervention) and the maxilla-first (control)

Eligibility criteria: 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

Primary outcomes:
measure: the change in maxilla stability
timeFrame: 6 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 6 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Middle East
Study officials:
affiliation: Cairo University
name: mohamed mh hamdy, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Esteves LS, Castro V, Prado R, de Moraes e Silva CA, 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.
citation: 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.
citation: Beziat 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.
citation: Liebregts J, Baan F, de Koning M, Ongkosuwito E, Berge 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.