CompletedNCT03353116Updated Oct 20, 2022

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

An interventional study of the mandible first and the maxilla first in Class III Malocclusion, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-20.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 24
Allocation: Randomized
Ages: 16 Years and older
Sex: All

Study summary

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

Read the 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)

Conditions studied

Class III Malocclusion

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Who can participate

Ages eligible: 16 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 24 participants (actual)

Study arms

Active comparator
maxilla first group
the maxillary osteotomy is going to be done and fixed first
Procedure: the maxilla first
Experimental
mandible first group
the mandibular osteotomy is going to be done and fixed first
Procedure: the mandible first

Interventions

Procedurethe mandible first
the mandible osteotomy is going to be done and fixed first
Also known as: the inverted sequence
Procedurethe maxilla first
the maxilla osteotomy is going to be done and fixed first
Also known as: the regular sequence

What researchers measure

Primary outcomes

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
Time frame: 6 months

Secondary outcomes

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
Time frame: 6 month

Study locations

1 site

Cairo University
Cairo, Middle East 11865, Egypt

References and documents

Publications

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. PubMed 24531245 ↗
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. PubMed 27668193 ↗
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. PubMed 19939425 ↗
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. PubMed 28839184 ↗

Study documents

Protocol and statistical analysis plan · Nov 23, 2017
Informed consent form · Nov 16, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — after the completion of my research i will publish the data in an international journal

Registry details

Key details

Study ID: NCT03353116
Lead sponsor: Cairo University
Responsible party: Mohamed Hamdy (Assistant lecturer, Cairo University) — Principal investigator
First posted: Nov 27, 2017
Start date: Jan 1, 2018
Primary completion: Jan 1, 2019
Completion: Jun 1, 2019
Last update: Oct 20, 2022

Study contacts

mohamed mh hamdy, master

principal investigator · Cairo University

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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