Evaluation of apnea-hypopnea index change and the incidence of obstructive sleep apnea in patients with class III skeletal deformity, after mandibular setback surgery with ApneaLink device.
Determining the incidence of obstructive sleep apnea and changes in the apnea-hypopnea index in patients with class III skeletal deformity after mandibular setback surgery with ApneaLink device
Design
This study will be performed as a double-blinded quasi-experimental.This is before-after interventional pilot research which would be executed on 10 patients for evaluation of apnea/hypopnea index by Apnea-link device. the outcome assessor and data analyzer will be blinded.
Settings and conduct
Oral and maxillofacial surgery department of Qaem hospital, Mashhad. The outcome assessor and the data analyzer will be blinded.
Participants/Inclusion and exclusion criteria
All of the non-smoker patients with skeletal class III deformities with the age range of 18-30 years old who candidate for orthogenetic surgery; with ASA 1 or 2; without congenital syndromes; without a history of respiratory diseases like rhinitis, asthma, bronchitis, would be included in our study. Exclusion criteria: Patients who would not attend for follow up
Intervention groups
The intervention in this study is mandibular setback surgery using a bilateral sagittal split osteotomy (BSSO) and maxillary advancement using Lefort 1 osteotomy. As a result, this study has no control group.
Main outcome variables
Apnea-hypopnea Index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150613022697N11
Registration date:2021-02-23, 1399/12/05
Registration timing:registered_while_recruiting
Last update:2021-02-23, 1399/12/05
Update count:0
Registration date
2021-02-23, 1399/12/05
Registrant information
Name
Sahand Samiee rad
Name of organization / entity
mashhad dental school,oral and maxillofacial department
Country
Iran (Islamic Republic of)
Phone
+98 51 3883 7289
Email address
samieerads@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of apnea-hypopnea index change and the incidence of obstructive sleep apnea in patients with class III skeletal deformity, after mandibular setback surgery with ApneaLink device.
Public title
Evaluation of the effect of mandibular setback surgery on Apnea-hypopnea Index with ApneaLink device.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-smoker patients between the ages of 18 and 40
Patients with skeletal class 3 deformity who are candidates for orthognathic mandibular setback surgery by bilateral sagittal split osteotomy (BSSO)
BMI less than 30 kg/m2 ASA 1,2
Exclusion criteria:
Patients with a history of respiratory diseases like rhinitis, asthma, bronchitis.
Patients with a history of maxillofacial congenital syndromes .
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the outcome assessor and data analyzer will not know about the study groups. Regarding the assessor, who is a pulmonologist will not be aware of the surgical intervention and the amount of mandibular movement in millimeters. The data analyzer will be blinded and all data will be provided in the form of coding to him.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Mashhad university of medical sciences
Street address
Ghoreishi building, Daneshghah avenue.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2020-12-16, 1399/09/26
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1399.109
Health conditions studied
1
Description of health condition studied
Obstructive sleep apnea
ICD-10 code
G47.33
ICD-10 code description
Obstructive sleep apnea (adult) (pediatric)
Primary outcomes
1
Description
Apnea-hypopnea Index
Timepoint
Before surgery, one month and three months after surgery
Method of measurement
ApneaLink device
2
Description
Obstructive Sleep apnea recovery
Timepoint
Before surgery, one month and three months after surgery
Method of measurement
En Apnea link device measurement.
Secondary outcomes
empty
Intervention groups
1
Description
The intervention in this study is mandibular setback surgery by bilateral sagittal split osteotomy (BSSO) and maxillary advancement using Lefort 1 osteotomy.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and maxillofacial surgery department of Qaem hospital, Mashhad
Full name of responsible person
Sahand Samieerad
Street address
Ahmadabad boulvar, Mashhad Qaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3840 0000
Fax
Email
samieerads@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Ghoreishi building, Daneshghah avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
91779448959
Phone
+98 51 3841 2081
Fax
+98 51 3841 2081
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sahand Samieerad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
samieerads@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sahand Samieerad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.