Changes of the Upper Airway Volume After Orthognathic Surgery

January 27, 2023 updated by: Martin Bengtsson, Lund University Hospital

Changes of the Upper Airway Volume After Orthognathic Surgery - is This a Treatment Option of Severe Obstructive Sleep Apnea?

The aim of the present project is to analyze the impact from orthognathic surgery on the upper airway respiratory volume.

The primary objective is comparison of differences in the in the airway changes due to maxillary movements and mandibular movements.

Secondary objectives are the analysis of any correlation between the magnitude of the movement and the airway volume, correlation between the direction of the movements and the changes in airway volume and correlation with Health-Related Quality of Life (HRQoL). Expected confounding factors like smoking habits and Body Mass Index (BMI) will be analyzed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background Orthognathic surgery affects the position of the teeth and jaws. The upper airway compartment is in close approximation to these tissues. Consequently, changes of the respiratory volume after surgical treatment in this region is expected.

Orthognathic surgery The correction of severe malocclusions and dentofacial deformities has since the beginning of 20th century been treated with orthodontic and surgical methods. Epidemiologic surveys reveal that about 5 % of the western population has dentofacial disproportions of a magnitude that affect both function and facial aesthetics.

Respiratory disability Obstructive sleep apnea, estimated to occur in between 5% and 10% of the western countries' population. Disabilities in the upper airway may affect the patient's general health and quality of life. Breathing incapability often lead to impaired sleep and consequently decrease the individual's overall capacity and performance. Known predisposing factors are obesity, smoking and age.

Treatment of respiratory disabilities Medical, behavioral and surgical treatment options are prospected methods and the treatment is individually planned in detail. The complex nature of obstructive sleep apnea may require multidisciplinary assessment.

Orthognathic surgery as treatment for obstructive sleep apnea syndrome (OSAS) Correction of anatomical abnormalities may cure obstructive sleep apnea or improve compliance with positive airway pressure treatment. Orthognathic surgery with an anterior movement of the jaws can increase the airway volume and facilitate breathing.

Measurements and evaluation of the upper airway volume Different methods of measuring the upper airway, like physio metric and radiological are present.

Project plan Subjects The study is performed retrospectively on a prospective material. Sixty-two consecutive patients aged between 18 to 30 years with Angle class III occlusion were included in the study.

Patients with systemic diseases in the musculoskeletal apparatus, drug abuse, poor psychic status or disease in the temporomandibular joint were excluded from the study.

Methods The study is performed retrospectively on a prospective material. Examination with clinical examination, BMI, HRQoL questionnaire, dental casts, photography and two- and three-dimensional radiographs and cephalometric measures was performed prior to surgery.

The patient's data (x-ray and photographs) were linked together in computer software programs and used for cephalometric analysis and simulation of the orthodontic and surgical movements (Fasad® and Simplant® PRO 12.00 OMS). The treatment was performed in accordance with this plan.

The last follow up was performed 12 months after surgery including identical registrations as prior to surgery, described above. HRQoL questionnaires consisted of Oral Health Impact Profile (OHIP-S), Jaw Functional Limitation Scale (JFLS-20) and Orofacial Aesthetic Scale (OAS-S). The results from the presurgical questionnaire will be compared with the postsurgical results. Twenty subjects were asked to fill in the follow-up questionnaire twice with two weeks interval for a reliability test of the method.

The pre- and postoperative CT will be compared in a software for measurements of upper airway volume with the software Philips IntelliSpace® Portal, version 11. Measures will be performed with an divided analysis of the upper airway according to the method described by Kim. Thus, the upper airway segmented into four compartments. The measurements will be performed on the sole segment volume and the total airway volume. A comparison of jaw movements, changes in airway volume, BMI and HRQoL will be performed.

Statistical methods The sample size, 62 patients, was based on numbers included in previous similar studies from other centers.

Simple statistics, mean and standard deviation (SD), for all variables will be used. Differences in airway volume and movements, preoperatively and postoperatively will be compared with McNemar's-test. Wilcoxon's paired-sample test will be used for analyzing airway volume before and after surgery as a numeric variable. The reliability test, performed as a test-retest, will be analyzed with the intraclass correlation coefficient, Fisher's test for pair comparisons and Pearson's correlation coefficient. Mann-Whitney-test will be performed to detect differences between questionnaire responses and clinical findings, i.e. BMI, and volumetric findings. The data will be assessed by using Spearman correlation analysis and simple linear regression analysis. Two-sided tests and alpha level 0.05 will be used. Confidence interval (CI) will be calculated. For all computations IBM® SPSS® statistical software will be used.

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 22185
        • Dept Oral and Maxillofacial Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients, aged between 18 to 30 years, with diagnosed maxillary retrognatism and Angle class III occlusion deviating at least 5 mm in sagittal and/or vertical aspects from normal occlusion

Description

Inclusion Criteria:

  • Maxillary retrognatism and Angle class III occlusion deviating at least 5 mm in sagittal and/or vertical aspect from normal occlusion measured as interincisal distance
  • Age between 18 to 30 years

Exclusion Criteria:

  • Systemic diseases in the musculoskeletal apparatus
  • Drug abuse
  • Poor psychic status
  • Disease in the temporomandibular joint

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in upper airway volume
Time Frame: Preoperative and 12 months postoperative follow up.
Measurements in three dimensional radiographs from pre- and postoperative recordings.
Preoperative and 12 months postoperative follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation BMI and upper airway volume.
Time Frame: Preoperative and 12 months postoperative follow up.
Correlation between changes in Upper airway volume and Body mass index (BMI).
Preoperative and 12 months postoperative follow up.
Direction of surgical movements
Time Frame: Preoperative and 12 months postoperative follow up.
Correlation between the direction of the surgical movements and the changes of the upper airway volume.
Preoperative and 12 months postoperative follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University Hospital

Investigators

  • Principal Investigator: Martin Bengtsson, DDS, PhD, Skåne University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2021

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

December 28, 2022

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Estimate)

January 30, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OFRS939554

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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