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

Not Applicable

Completed

• Conditions: Class III Malocclusion
• Interventions: Procedure: the maxilla first; Procedure: the mandible first

• Registration Number: NCT03353116
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-22
• Study First Posted: 2017-11-27
• Study Start: 2018-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-06-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
maxilla first group	the maxilla first	the maxillary osteotomy is going to be done and fixed first
mandible first group	the mandible first	the mandibular osteotomy is going to be done and fixed first

Primary Outcome Measures

Name	Time	Method
the change in maxilla stability	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

Name	Time	Method
Patient satisfaction	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

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Middle East, Egypt