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

• ClinicalTrials.gov Identifier: NCT03353116
• Recruitment Status: Unknown
• First Posted: November 27, 2017
• Last Update Posted: November 27, 2017
• Sponsor: Cairo University
• Information provided by (Responsible Party): Mohamed Hamdy, Cairo University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Class III Malocclusion	Procedure: the mandible first; Procedure: the maxilla first	Not Applicable

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)

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Treated by Mandible-first Approach Versus Maxilla-first Approach; Randomized Controlled Clinical Trial
• Estimated Study Start Date: January 1, 2018
• Estimated Primary Completion Date: January 1, 2019
• Estimated Study Completion Date: June 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: maxilla first group; the maxillary osteotomy is going to be done and fixed first	Procedure: the maxilla first; the maxilla osteotomy is going to be done and fixed first; Other Name: the regular sequence
Experimental: mandible first group; the mandibular osteotomy is going to be done and fixed first	Procedure: the mandible first; the mandible osteotomy is going to be done and fixed first; Other Name: the inverted sequence

Outcome Measures

Primary Outcome Measures :

1. the change in maxilla stability [ Time Frame: 6 months ]

   to assess the change in maxillary stability on cone beam CT obtained immediately and 6 month postoperative.

   the measuring unit is millimeter

Secondary Outcome Measures :

1. Patient satisfaction [ Time Frame: 6 month ]
   "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

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: mohamed mh hamdy, master; 01002838699 ext +202; dr.hamdy88@gmail.com

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: mohamed mh hamdy, master; Cairo University

  Study Documents (Full-Text)

Documents provided by Mohamed Hamdy, Cairo University:

Informed Consent Form  [PDF] November 16, 2017

Study Protocol and Statistical Analysis Plan  [PDF] November 23, 2017

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: Mohamed Hamdy, Assistant lecturer, Cairo University
• ClinicalTrials.gov Identifier: NCT03353116
• Other Study ID Numbers: CEBD-CU-2017-11-16
• First Posted: November 27, 2017
• Last Update Posted: November 27, 2017
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: after the completion of my research i will publish the data in an international journal

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Prognathism; Malocclusion; Malocclusion, Angle Class III; Tooth Diseases; Stomatognathic Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Mandibular Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities