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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03353116
Other study ID # CEBD-CU-2017-11-16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date June 1, 2019

Study information

Verified date October 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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)


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
the mandible first
the mandible osteotomy is going to be done and fixed first
the maxilla first
the maxilla osteotomy is going to be done and fixed first

Locations

Country Name City State
Egypt Cairo University Cairo Middle East

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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

Outcome

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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