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Completed

NCT Number: NCT03353116

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

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

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Key information

Conditions

Class III Malocclusion Malocclusion Malocclusion, Angle Class III Stomatognathic Diseases Tooth Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Middle East, 11865, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

the mandible first

Procedure

the mandible osteotomy is going to be done and fixed first

Other names: the inverted sequence

the maxilla first

Procedure

the maxilla osteotomy is going to be done and fixed first

Other names: the regular sequence

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Treated by Mandible-first Approach Versus Maxilla-first Approach; Randomized Controlled Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2017
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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