FIT INSTRUCTIONS
Introduction
The Clench Relief Mouth Piece PRO RX is a custom-fit mouthguard which allows the user to achieve a jaw position that protects teeth and restorations from injury due to clenching, grinding, and bruxism. The product also provides temporary relief of TMD and bruxism by reducing muscle tension and allows for temporary treatment of TMD along with the relief of associated headaches and pains.
The Clench Relief Mouth Piece PRO RX frame is designed to help reposition the lower jaw into a place of low muscle activity and decompress the jaw joint. It allows the back molars to bite in a centered and forward position that decreases muscle activity and de-compresses the jaw joint allowing the disc to remain on the condyle of the jaw which can help alleviate popping and clicking. It achieves this by using an anterior alignment guide that allows the patient’s front top and bottom central incisors to position and center themselves inside the groove of the alignment guide. A custom secure fit that engages the back molars is achieved using PVS which hardens in approximately 2 minutes. Once it hardens, the alignment guide is removed thus removing any contact with the anterior teeth and contact remains only on the posterior teeth.
The Clench Relief Mouth Piece may be used in patients 18 years of age and older. Regular follow up visits are recommended to ensure the mouthguard fits appropriately.
Indications for Use
The Clench Relief Mouth Piece PRO RX is indicated for protection of teeth and restorations from injury due to teeth grinding, bruxism, and jaw clenching; temporary relief of TMD and bruxism by reducing muscle tension, and temporary treatment of TMD along with the relief of associated headaches and pains.
Disclaimer
Clench Relief Mouth Piece may not be suitable for all patients. This product should be used with care in patients with missing teeth, limited jaw mobility, or extreme jaw mobility.
Contraindications
- Known allergies to Poly Vinyl Siloxane
Cleaning and Storage
After each use, brush you mouth piece with a wet soft toothbrush with water only. Rinse with cool water and avoid hot water. Allow your Clench Relief Mouth Piece to air dry. Use the mouth piece case to store your mouth piece when not in use.
Note: Do not clean your CRMP with boiling water or denture cleaner or soak it in hydrogen peroxide.
Please read all instructions before using Clench Relief PRO RX Mouth Piece.
Step 1
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Have the patient brush their teeth and rinse mouth with water.
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Prepare all required items by opening the Clench Relief Mouth Piece (CRMP) kit and laying out all provided items. The kit contains the following items:
2 sets of PVS base (3.0 grams) and PVS catalyst (3.0 grams) in containers ( an extra set is provided as a replacement or do over for a second attempt if the first attempt did not set properly)
Clench Relief Mouth Piece Frame (CRMPF) and Clench Relief Alignment Guide (CRAG)
Nitrile gloves
Mouth Piece Case
Instructions -
Before starting, you will need a timer and a sharp blade or scalpel for trimming
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Snap the alignment guide into the center of the Clench Relief Mouth Piece Frame. Use the centerline of the alignment guide for proper center alignment with the Clench Relief Mouth Piece Frame and make sure that the alignment guide when attached to the frame and when placed in the patient’s mouth, that is centered between the two front teeth or in the midline of the patients face and the lower jaw chin.
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At this point, the prescriber can insert the Clench Relief Mouth Piece Frame with the attached alignment guide in and out of the patients mouth to get a sense on how it fits before starting the timed process of mixing, rolling and packing the Clench Relief Fit Material into the Clench Relief Mouth Piece Frame.
Step 2
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Don the nitrile gloves. Start the timer and knead both components of the Clench Relief Fit Material with fingers and thumbs. Stretch and fold several times, until a uniform color is achieved. This process should take about 30 seconds. Be careful to watch the stopwatch as the CR Fit Material will begin to harden by 60 seconds. Make sure it is mixed, rolled, packed into the mandibular side of the mouthpiece frame and in the patients mouth by 90 seconds from the time you start mixing the vinyl poly- siloxane to avoid the fit material from setting pre-maturely.
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Form a uniform tube with the Clench Relief Fit Material which should be the length of each side of the latticed part of the CRMF (approximately 30 mm on each side). Then pinch the middle of the rolled putty to separate into two equal rolls. This process should take ten seconds (total 40-50 seconds from time of beginning to mix fit material).
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Pack each half of the Clench Relief Fit Material into the mandibular side (underneath) of both sides of the Mouth Piece Frame
Note: The Clench Relief Fit Material goes into the bottom pockets of the Mouth-Piece Frame.
Step 3
Hold for 3 minutes--
Remove and let PVS Cure for 10- 15 minutes--
Trim and Remove CRAG
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Place in patients’ mouth and have the upper and lower central incisors gently grip the CRAG and hold for two minutes while the PVS begins to cure around the posterior teeth: Ensure the center line of the CRAG is in-between the two front teeth and centered with the patients midline of their face and lower chin. Only the two front teeth should be holding the mouth piece in place on the CRAG, while the recently mixed, soft Clench Relief Fit Material hardens and sets to conform to the shape of the patients’ rear molar teeth.
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Once removed from the mouth, let the Clench Relief Fit Material set inside the Mouth Piece for three minutes and then remove and allow the Poly Siloxane fully set for 10- 15 minutes before use. Cut away or trim excess after curing with scissors or sharp knife.
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The patient should have a snug custom-fit over the mandibular teeth. The upper teeth should be indexed into the PVS material.
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The mouthpiece should be replaced if there is visible damage or if materials should be replaced in order to maintain good oral hygiene.
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Please have the patient return to inspect the fit and evaluate the integrity of the mouth piece in one week followed by consecutive 3 month examination visits. Any degradation of the polyvinyl siloxane should be replaced and re-set with a new set at this visit.
Warnings
- Clench Relief Mouth Piece should not be fit on or over loose teeth.
- Clench Relief Mouth Piece should not be worn if the patient feels more pain.
- Clench Relief Mouth Piece should not be worn if the patient experiences shortness of breath.
- Clench Relief Mouth Piece fabrication for patients with fixed bridges with undercuts must be inspected as the vinyl polysiloxane may lock the mouthpiece during fabrication and the risk of the vinyl polysiloxane breakage can cause a choking hazard.
- Clench Relief Mouth Piece should not be used in patients under the age of 18.
- This is a short-term device to help reduce clenching, grinding, and bruxism and is not intended for long term use.
Information for Patient
Prescribers should convey the following information to the patient:
- Patients should discontinue use of the mouthguard and contact the prescriber in the following cases: o
- if loose teeth or a change in the bite develop.
- if they experience pain or bleeding gums or other irregularities while using Clench Relief Mouth Piece PRO RX.
- the product falls out of the mouth easily or does not fit properly or causes gag reflex.
- the product disrupts breathing.
- Do not use for more than 3 months without a visit to your prescriber to examine and evaluate your progress.
- Follow the instructions of the prescriber to ensure safe and effective use.