ClinicalTrials.gg
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
01

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)

02

Conditions studied

  • Class III Malocclusion
03

In context

Malocclusion, Angle Class III

57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.

This study's enrollment of 24 is below the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.

Browse Malocclusion, Angle Class III studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  4. Patients with no signs or symptoms of temporomandibular disorders.

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

06

What researchers measure

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

    Time frame: 6 months

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Cairo University
    Cairo, Middle East 11865, Egypt
08

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

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Jan 2019, 12 months.

Of 37 non-industry interventional studies with no phase under Malocclusion, Angle Class III, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 12 months is close to that.

Counting every sponsor, half of 38 studies reached it within 13 months; a quarter within 10 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2017
First posted
Nov 27, 2017
StartActual
Jan 1, 2018
Primary completionActual
Jan 1, 2019
CompletionActual
Jun 1, 2019
Last update
Oct 20, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion