Capnographic and pulse oximetric comparison of breathing function changes in patients with mandibular deficiency before and after treatment with a removable functional appliance
The aim of this study is to compare the changes in respiratory function in patients with mandibular deficiency before and after treatment with a removable functional appliance using capnography and pulse oximetry methods
Design
This semi experimental prospective study will be carried out on 22 patients aged between 8 to 15 years old. Sampling method is purposefully non randomized.
Settings and conduct
This semi experimental prospective study will be carried out on 22 patients aged between 8 to 15 years admitted to the Faculty of Dentistry of Ahvaz Jundishapur University of Medical Sciences. The end-tidal concentration of carbon dioxide is recorded by capnograph device. Patients sit on a chair and nasal canola is placed on the nose. Exhaled carbon dioxide levels will be recorded for 6 minutes. Pulse oximetry will be carried out simultaneously using a probe that is placed on index finger. Before starting treatment and after treatment with functional appliance for 6 months (T1) PET CO2 and Spo2 are measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: skeletal class two division one malocclusion with normal upper jaw (SNA=80-84) and deficient mandible (SNB <77). Overjet more than 5 mm.
Exclusion criteria: history of previous orthodontic treatment; systemic disease that affect general and skeletal growth; craniofacial syndromes; respiratory problems not related to orthodontics.
Intervention groups
In this study a removable functional appliance known as activator is used to treat patients. The end-tidal concentration of carbon dioxide is recorded by capnograph device. Patients sit on a chair and nasal canola is placed on the nose. Exhaled carbon dioxide levels will be recorded for 6 minutes. Pulse oximetry will be carried out simultaneously using a probe that is placed on index finger.
Main outcome variables
End tidal carbon dioxide, oxygen
General information
Reason for update
Acronym
Capnographic and pulse oximetric comparison of breathing function changes in patients with mandibul
IRCT registration information
IRCT registration number:IRCT20160927030014N2
Registration date:2020-05-25, 1399/03/05
Registration timing:retrospective
Last update:2020-05-25, 1399/03/05
Update count:0
Registration date
2020-05-25, 1399/03/05
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 7076
Email address
eini.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
2016-10-22, 1395/08/01
Actual recruitment end date
2016-11-21, 1395/09/01
Trial completion date
2017-05-22, 1396/03/01
Scientific title
Capnographic and pulse oximetric comparison of breathing function changes in patients with mandibular deficiency before and after treatment with a removable functional appliance
Public title
Effect of functional orthopedic appliance on patients with mandibular deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Skeletal class two division one malocclusion with normal upper jaw (SNA=80-84) and deficient mandible (SNB <77).
Overjet more than 5 mm
Exclusion criteria:
History of previous orthodontic treatment
Systemic disease that affect general and skeletal growth
Craniofacial syndromes
Respiratory problems not related to orthodontics
Age
From 8 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
Actual sample size reached:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ahvaz jundishapur univercity of medical sciences
Street address
Golestan blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357
Approval date
2015-09-21, 1394/06/30
Ethics committee reference number
IR.AJUMS.REC.1394.643
Health conditions studied
1
Description of health condition studied
Mandibular deficiency
ICD-10 code
K07.1
ICD-10 code description
Anomalies of jaw-cranial base relationship
Primary outcomes
1
Description
End-Tidal Carbon Dioxide
Timepoint
before intervention, six months after intervention
Method of measurement
Capnography device
2
Description
Percent of blood oxigen saturation
Timepoint
Before intervention, six months after intervention
Method of measurement
Pulse oximetery device
Secondary outcomes
1
Description
Respiration rate
Timepoint
The beginning of the study, six months later
Method of measurement
Capnograph device
Intervention groups
1
Description
In this study, the effect of treatment with an activator functional device (which used for stimulating the growth of the mandible) was assessed on the level of end tidal carbon dioxide and percentage of oxygen saturation in patient with mandibular deficiency. End tidal carbon dioxide and percentage of oxygen saturation were measured with a Capnograph and pulse oximeter devices Respectively before treatment and six months after treatment.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthodontics department, faculity of dentistry, ahvaz jundishapur university of medical sciences
Full name of responsible person
ebrahim eini
Street address
Dey street
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 0074
Email
eini.e@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Nader Saki
Street address
Deputy of research development of ahvaz jundishapur university of medical sciences
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 7681
Email
eini.e@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ebrahim Eini
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dey street
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 7076
Fax
+98 61 3336 7566
Email
eini.e@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ebrahim Eini
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dey street
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 7076
Fax
+98 61 3336 7566
Email
eini.e@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ebrahim Eini
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dey street
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 7076
Fax
+98 61 3336 7566
Email
eini.e@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on the main consequence
When the data will become available and for how long
Access periods starting 1 month after the publication of results
To whom data/document is available
Everyone
Under which criteria data/document could be used
In all circumstances
From where data/document is obtainable
ebrahim eini 09163644166
What processes are involved for a request to access data/document