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What Are the Three Dimensional Soft Tissue Changes That Occur After Orthognathic Surgery for Skeletal Class II Patients? Pre-test Post-test Quasi Experimental Study

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ClinicalTrials.gov Identifier: NCT03687307
Recruitment Status : Unknown
Verified October 2018 by Amira Moussa, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : September 27, 2018
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Amira Moussa, Cairo University

Study Description
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Brief Summary:
the aim of the study is to establish reference data that could be used for the creation of more accurate three dimensional prediction of soft tissue outcome.

Condition or disease
Orthognathic Surgery

Detailed Description:
in this study, 15 skeletal class 2 orthognathic patients will be selected. CBCT and proface will be done preoperatively. after the surgery and 6 months later the imaging investigations will be repeated to investigate the soft tissue changes that have resulted due to the bone movement.
Study Design
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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: What Are the Three Dimensional Soft Tissue Changes That Occur After Orthognathic Surgery for Skeletal Class II Patients? Pre-test Post-test Quasi Experimental Study
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 3D soft-tissue changes (linear) [ Time Frame: 6 months ]
    the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery


Secondary Outcome Measures :
  1. Proportion of soft tissue change to hard tissue change [ Time Frame: 6 months ]
    the distance that the soft tissue has moved compared to the underlying bone, as a percentage.

  2. Is the esthetic outcome as expected/imagined? [ Time Frame: 6 months ]
    using a 100mm visual analogue scale the patient will be asked to score how the aesthetic outcome measured against his expectations. 0mm is the worst score where the changes havent met the expectations at all and 100mm is where the outcome has perfectly met the expectation.

  3. 3D soft-tissue changes (angular) [ Time Frame: 6 months ]
    the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery

  4. 3D soft-tissue changes (volumetric) [ Time Frame: 6 months ]
    the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with class 2 skeletal deformity, over 18 years and younger than 40
Criteria

Inclusion Criteria:

  • Patients with class II skeletal deformity
  • Patients must be over 18 years of age to allow for growth cessation
  • Patients must not have any systemic condition which contraindicates general anaesthesia

Exclusion Criteria:

  • o patients with cleft palate

    • patients with syndromes affecting their craniofacial structure
    • patients with facial scars
    • patients with severe facial asymmetry
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Amira Moussa, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03687307    
Other Study ID Numbers: cebd-cu-2017-04-05
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amira Moussa, Cairo University:
class II,
soft tissue changes
CBCT