To what extend should a possible worsening of the OSA condition, caused by an increase of mouth opening and partial palatinal coverage, be taken into consideration in daily dental practice, when an occlusal splint is placed in the mouth.Amendement:…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
OSAS
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Apnoea- Hypopnoea Index (AHI)
Secondary outcome
Epworth Sleepiness Scale ( ESS), Body Mass Index ( BMI), neck circumference in
cm and the side effects of a stabilization splint.
Amendement: The concentrations in the blood of the following factors : MMP-8,
CRP en Pro-BNP.
Background summary
Gagnon et al (2004) investigated the possibility that an occlusal splint would
change the airway patency in obstructive sleep apnoea ( OSA ) patients during
sleep. The authors hypothesized that the use of an oral splint may aggravate
the respiratory disturbance in OSA patients. They concluded that the use of an
occlusal splint in OSA patients is associated with a risk of aggraviation of
respiratory disturbances.
Obstructive sleep apnoea patients have a higher risk to develop cardiovascular
diseases and to pass away because of a heart attack. Many blood factors are
considered to be related with the OSA condition, such as *serum matrix
metalloprotease-8* (MMP-8) , *C-reactive proteine* (CRP) en *pro-brain
natriuretic peptide* (Pro-BNP).
Study objective
To what extend should a possible worsening of the OSA condition, caused by an
increase of mouth opening and partial palatinal coverage, be taken into
consideration in daily dental practice, when an occlusal splint is placed in
the mouth.
Amendement: It will be investigated whether there is a connection between
several blood factors and the severity of the OSA condition as well as with the
wearing of a splint or a MAD (snoring device).
Study design
Cross- over RCT design study.
Intervention
Occlusal splint for the upper jaw.
Study burden and risks
The patients need to spend time for this research. They will need to come to
ACTA 3 times . They also need to sleep with the ambulatory equipment 6 times at
home. Before each night, the mounting of the equipment and blood sample
collection takes 2 hours.
Blood collection will take place 4 times during the study. (10 ml each time
that will be divided in 4 portions of 2,5 ml) The primair care of the blood
samples will be done in Slotervaart Medical Center and the analysis will be
done in Helsinki, Finland.
The whole time that the patient need to spend 14 hours.
Louwesweg 1
1066 EA Amsterdam
NL
Louwesweg 1
1066 EA Amsterdam
NL
Listed location countries
Age
Inclusion criteria
-All patients should be at least 18 years old
-OSA patients, diagnosis based on a baseline polysomnographic recording at the hospital, with an AHI up to 30
Exclusion criteria
-Medicine usage that effects on sleep
-BMI more than 40
-Inadequate dentition
-Severe bruxers
-TMD patients
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL23988.048.08 |