Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Using the Inverted Sequence Approach

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353116
• Other study ID #: CEBD-CU-2017-11-16
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Class III Malocclusion
• Malocclusion
• Malocclusion, Angle Class III
• Prognathism

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