Somno
Guard
SP Soft
Medical oral appliance to treat snoring and mild or moderate obstructive sleep apnoea in adults
Content:
2 oral trays, 4 sets of connecting straps (23 mm
–
34 mm), storage case, user instructions
To achieve an optimal therapeutic result, it is recommended that SomnoGuard
®
SP Soft is fitted by a physician (e.g., dentist, ENT physician, physician in
the sleep laboratory) or their trained medical staff.
Instructions
(Read instructions carefully before use)
Date of information: 01.02.2021
Description:
SomnoGuard
®
SP Soft is a two-piece mandibular advancement device that allows limited mouth opening. The hard
outer tray shells are filled with a thermoplastic material. After heating the trays in a boiling water bath the thermoplastic
material becomes easily mouldable. Deep teeth impressions are formed when biting into the soft material. After the
appliance cools down in a cold water bath, the material hardens and maintains its new shape. The lower jaw
advancement can be incrementally adjusted by two connecting straps of equal length that connect the upper and the
lower tray. The opening of the respiratory tract depends on the extent of the adjusted lower jaw advancement.
SomnoGuard
®
SP Soft is also suitable for patients with a receding lower jaw (retrognathia).
Fig. 1
Indications:
-
Treatment of primary snoring and mild or moderate obstructive sleep apnoea in adults
-
In case of CPAP intolerance and in order to reduce CPAP pressure
-
Sporadic use by patients with obstructive sleep apnoea instead of CPAP when travelling, if advised by a medical professional
Contraindications:
-
Patients under 18 years
-
Central sleep apnoea
-
Severe respiratory disorders
-
Epilepsy
-
Temporomandibular joint disorder
-
Insufficient number of teeth, large gaps between the teeth
-
Periodontitis, loose teeth, unstable dental crowns or prostheses, tooth decay
-
(Strong) gag reflex
-
Limited mandibular advancement capacity
Attention:
If the patient’s dental condition appears uncertain and in case of occlusal abnormalities
, a dental check-up is strongly recommended before starting the
treatment.
Possible side effects:
-
Mouth dryness or initial hypersalivation, which normalises with adaptation to the appliance
-
Morning discomfort by temporary pain from TMJ or teeth, which normally reduces with adaptation
-
Transitory bite changes, which will normally disappear within 30
–
60 minutes after removing the appliance from the mouth
-
In case of a long-term treatment, changes of tooth position are possible.
-
During the first few nights the appliance might not be kept in the mouth for the whole night. This is normal. The adaptation process may take 1
–
2 weeks.
In case of any persisting or severe side effects stop using the appliance and consult your medical professional.
Warnings:
-
Snoring can be a symptom of breathing arrests that may contribute to serious health problems such as cardiovascular diseases. Ask for your medical
prof
essional’s help to find out why you snore.
-
The therapeutic effect of the oral appliance therapy should be controlled by adequate diagnostic measures quite soon after the beginning of treatment,
especially with those patients having breathing arrests at night due to obstructive sleep apnoea. Consult your medical professional.
-
In case of severe pain from TMJ or other persistent discomfort, stop using the appliance and consult your medical professional. He or she will then find
out whether this condition had been caused by the oral appliance and can modify the appliance if necessary.
-
You should visit your dentist at regular intervals, especially if you are wearing your appliance every night.
Take your appliance with you.
Special notes:
-
Thoroughly check the appliance for any uncommon changes (such as cracks or debonding) before and after every use. Do not use the appliance if it is
damaged in any way.
-
The average durability of SomnoGuard
®
SP Soft is about 1 ½ years. Bruxism and strong
jaw movements might decrease the average durability of your
oral appliance. Consult your medical professional for therapeutic alternatives especially designed for bruxists.
-
Please also refer to the illustrations for fitting our SomnoGuard
®
oral appliances on the internet at www.tomed.com
Care:
Clean your oral appliance every morning with a soft toothbrush and a special cleaning product (e.g. Curaprox “daily” gel for daily cleaning, Curaprox “weekly”
concentrate for weekly cleaning; available from TOMED) or 1
–
2 drops of a colourless washing-up liquid.
Do not clean it with products that contain bleach as it
could damage the appliance.
Always rinse the appliance with cold water, let it dry in the open air and keep it in the storage case provided.
