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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03353116
Collaborator
(none)
24
2
17

Study Details

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
  • Procedure: the mandible first
  • Procedure: the maxilla first
N/A

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
Anticipated 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
Anticipated Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Jan 1, 2019
Anticipated Study Completion Date :
Jun 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 Names:
  • 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 Names:
  • the inverted sequence
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Mohamed Hamdy, Assistant lecturer, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03353116
    Other Study ID Numbers:
    • CEBD-CU-2017-11-16
    First Posted:
    Nov 27, 2017
    Last Update Posted:
    Nov 27, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 27, 2017