Malocclusion Clinical Trial
Official title:
Changes of the Upper Airway Volume After Orthognathic Surgery - is This a Treatment Option of Severe Obstructive Sleep Apnea?
NCT number | NCT05060133 |
Other study ID # | OFRS939554 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 15, 2021 |
Est. completion date | December 28, 2022 |
Verified date | January 2023 |
Source | Lund University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | December 28, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Dept Oral and Maxillofacial Surgery | Lund |
Lead Sponsor | Collaborator |
---|---|
Lund University Hospital |
Sweden,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in upper airway volume | Measurements in three dimensional radiographs from pre- and postoperative recordings. | Preoperative and 12 months postoperative follow up. | |
Secondary | Correlation BMI and upper airway volume. | Correlation between changes in Upper airway volume and Body mass index (BMI). | Preoperative and 12 months postoperative follow up. | |
Secondary | Direction of surgical movements | Correlation between the direction of the surgical movements and the changes of the upper airway volume. | Preoperative and 12 months postoperative follow up. |
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