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

NCT03353116 | Completed

• 1 other identifier: CEBD-CU-2017-11-16
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Class III Malocclusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient satisfaction

  6 month

Study Arms (2)

maxilla first group

ACTIVE COMPARATOR

the maxillary osteotomy is going to be done and fixed first

Procedure: the maxilla first

mandible first group

EXPERIMENTAL

the mandibular osteotomy is going to be done and fixed first

Procedure: the mandible first

Interventions

the mandible first PROCEDURE

the mandible osteotomy is going to be done and fixed first

Also known as: the inverted sequence

mandible first group

the maxilla first PROCEDURE

the maxilla osteotomy is going to be done and fixed first

Also known as: the regular sequence

maxilla first group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with skeletal class III malocclusion requiring bimaxillary orthognathic surgery
• Patients free from any systemic disease
• Patients who approved to be included in the trial and signed the informed consent
• Patients with no signs or symptoms of temporomandibular disorders.

You may not qualify if:

• Patients with cleft lip and palate "can have an unfavorable effect on facial growth (LARRY M. WOLFORD, 2002)"
• Patients receiving chemotherapy or radiotherapy "due to the risk of low bone quality and healing (JW, 2003) "
• Patients who refused to be included in the trial

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Middle East, 11865, Egypt

Location

Related Publications (4)

• 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.

  PMID: 24531245 BACKGROUND

• 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.

  PMID: 27668193 BACKGROUND

• 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.

  PMID: 19939425 BACKGROUND

• 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.

  PMID: 28839184 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• mohamed mh hamdy, master

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 27, 2017
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)