Clinical trial NCT03299023: The Effect of Tooth Position During Orthodontic Treatment on the Apnea/ Hypopnea Index (AHI)
Official title: The Effect of Tooth Position During Orthodontic Treatment on the Apnea/ Hypopnea Index (AHI)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Orthodontic Tooth Movement
Apnea
Sleep Disordered Breathing
Keywords: Obstructive Sleep Apnea
Orthodontics
Tooth Movement
Medibyte
Apnea
Hypopnea
Sleep
Disturbed Breathing
Lead sponsor: Harvard School of Dental Medicine
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 66
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include patients already registered at the Harvard School of Dental Medicine department of Orthodontics. Informed consent will be obtained before the questionnaires and portable monitor will be provided.

Brief summary: The study design of this research project involves orthodontic patients registered at the Harvard School of Dental Medicine who are deemed eligible to undergo orthodontic treatment and who have been provided with sufficient information to make informed consent to join the sleep study. These patients will be provided with the Medibyte sleep monitor and instructed on the proper manner in which it should be set up and worn for the one night study period. This process will be carried out twice throughout the course of the study, once before any orthodontic appliance has been cemented and once after the required amount of tooth movement has been attained with the orthodontic appliance still in place.

The de-identified data from the Medibyte monitor will be downloaded using the Braebon software and analyzed.

Detailed description: The study design of this research project involves recruiting orthodontic patients registered at the Harvard School of Dental Medicine who are deemed eligible to undergo orthodontic treatment and who have been provided with sufficient information to make informed consent to join the sleep study. The participants will be provided with the Medibyte sleep monitor and instructed on the proper manner in which it should be set up and worn for the one or two night study period. The purpose of the Medibyte monitor is solely to provide a calibrated value of AHI. The Medibyte monitor will not be utilized for investigations and/or treat, cure, mitigate a medical condition. This process will be carried out twice throughout the course of the study, once before any orthodontic appliance has been cemented and once after the required amount of tooth movement has been attained with the orthodontic appliance still in place.

The de-identified data from the Medibyte monitor will be downloaded using the Braebon software and analyzed providing a baseline value and post orthodontic movement AHI value. Additionally the patients arch width, length and other orthodontic measurements will also be taken both from their 3-D dental models and also their 2-D lateral cephalogram x-ray all of which are part of the routine orthodontic records (the x-rays will be taken regardless of the patients participation in the study since they are a required component of the orthodontic records taken at HSDM). The values obtained from the patients casts, lateral cephalogram and Medibyte AHI values will be analyzed both pre-orthodontic appliance cementation and also post tooth movement. The changes, if any, in the dental parameters as compared with the AHI values will allow the investigation of the orthodontic effects of expanding the maxilla, moving the front teeth either forwards or backwards which in effect cause changes to the airway and its effect on AHI values during sleep. In addition to the measurements taken intra-orally, surveys will also be undertaken to study any changes the patients may experience in their sleep and quality of life. If the Medibyte shows a severe reading for obstructive sleep apnea, these patients will then be referred to a sleep specialist for further more conclusive testing.

Eligibility criteria: Inclusion Criteria:

* Adults/children undergoing orthodontic care at HSDM

Exclusion Criteria:

* Patients already begun orthodontic therapy
* Patients obtaining orthognathic surgery
* Patients with high index of care need- have hypercapnia, hypoventilation, allergies or nose blockages

Primary outcomes:
measure: Relationship between dental movements and AHI
timeFrame: 2 Year
measure: Relationship between skeletal changes and AHI
timeFrame: 2 Year
measure: Relationship between airway cephalometric changes and AHI
timeFrame: 2 Year
Secondary outcomes:
measure: Relationship between the changes in the reported quality of life measurements and the AHI
timeFrame: 2 Year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Dental Medicine
state: Massachusetts
Study officials:
References: