Changes of the Upper Airway Volume After Orthognathic Surgery

NCT05060133 | Completed

• 1 other identifier: OFRS939554
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

OSA; Malocclusion; Dentofacial Deformities

Outcome Measures

Primary Outcomes (1)

• Changes in upper airway volume

  Measurements in three dimensional radiographs from pre- and postoperative recordings.

  Preoperative and 12 months postoperative follow up.

Secondary Outcomes (2)

• Correlation BMI and upper airway volume.

  Preoperative and 12 months postoperative follow up.

• Direction of surgical movements

  Preoperative and 12 months postoperative follow up.

Interventions

Orthognathic Surgery PROCEDURE

Surgical corrections of dentofacial deformities and malocclusions.

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (1)

Dept Oral and Maxillofacial Surgery

Lund, 22185, Sweden

Location

Related Publications (7)

• Baldwin CM, Griffith KA, Nieto FJ, O'Connor GT, Walsleben JA, Redline S. The association of sleep-disordered breathing and sleep symptoms with quality of life in the Sleep Heart Health Study. Sleep. 2001 Feb 1;24(1):96-105. doi: 10.1093/sleep/24.1.96.

  PMID: 11204058 BACKGROUND

• Moscarino S, Kotter F, Brandt M, Modabber A, Kniha K, Holzle F, Wolf M, Mohlhenrich SC. Influence of different surgical concepts for moderate skeletal class II and III treatment on the nasopharyngeal airway space. J Craniomaxillofac Surg. 2019 Oct;47(10):1489-1497. doi: 10.1016/j.jcms.2019.07.006. Epub 2019 Jul 18.

  PMID: 31399294 BACKGROUND

• Kim JS, Kim JK, Hong SC, Cho JH. Pharyngeal airway changes after sagittal split ramus osteotomy of the mandible: a comparison between genders. J Oral Maxillofac Surg. 2010 Aug;68(8):1802-6. doi: 10.1016/j.joms.2009.11.010. Epub 2010 May 26.

  PMID: 20537778 BACKGROUND

• Kim YJ, Hong JS, Hwang YI, Park YH. Three-dimensional analysis of pharyngeal airway in preadolescent children with different anteroposterior skeletal patterns. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):306.e1-11; discussion 306-7. doi: 10.1016/j.ajodo.2009.10.025.

  PMID: 20197163 BACKGROUND

• Bengtsson M, Wall G, Greiff L, Rasmusson L. Treatment outcome in orthognathic surgery-A prospective randomized blinded case-controlled comparison of planning accuracy in computer-assisted two- and three-dimensional planning techniques (part II). J Craniomaxillofac Surg. 2017 Sep;45(9):1419-1424. doi: 10.1016/j.jcms.2017.07.001. Epub 2017 Jul 12.

  PMID: 28800842 BACKGROUND

• Bengtsson M, Wall G, Miranda-Burgos P, Rasmusson L. Treatment outcome in orthognathic surgery - A prospective comparison of accuracy in computer assisted two and three-dimensional prediction techniques. J Craniomaxillofac Surg. 2018 Nov;46(11):1867-1874. doi: 10.1016/j.jcms.2017.01.035. Epub 2017 Feb 13.

  PMID: 28318923 BACKGROUND

• Pellby D, Bengtsson M. Do Patients Detect Changes in Breathing After Orthognathic Surgery? J Oral Maxillofac Surg. 2024 Jan;82(1):36-46. doi: 10.1016/j.joms.2023.09.017. Epub 2023 Sep 27.

  PMID: 37858599 DERIVED

MeSH Terms

Conditions

Malocclusion; Dentofacial Deformities

Interventions

Orthognathic Surgery

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry

Study Officials

• Martin Bengtsson, DDS, PhD

  Skane University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Oral and Maxillofacial Surgeon

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 29, 2021
• Study Start: May 15, 2021
• Primary Completion: August 31, 2022
• Study Completion: December 28, 2022
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)