Top comfort is the first and only protector of brackets made of light-curing orthodontic wax on the market that prevents injuries possibly caused by contact between the components of fixed braces (brackets, tubes) and the soft tissues in the mouth of the patient. It is light curing and indicated for coating protuberant and/or acute parts of orthodontic braces that are in contact with the cheek or tongue, forming a smooth and rounded surface to prevent abrasion, perforations and other forms of local irritation.
Characteristics and Advantages
• Effective protection: gives a rounded form to the pointy edges of fixed parts of dental braces that could damage the soft tissues of the mouth.
• Easy to apply: direct from the syringe (ready to use), with suitable viscosity to prevent undesired outflow.
• Lasting comfort: resistant resin that is retained on the location where it is applied, enabling recovery from injury.
• Convenience for the patient: no need for frequent re-applications.
• Aesthetics: color and translucency that do not significantly interfere in the aesthetics of the smile.
• Simple removal: when necessary, the polymer can be easily fragmented and removed with the aid of small pliers.
• Coating the protuberant/angled parts of orthodontic braces (braces, tubes), preventing injuries to soft tissues in the mouth.
• Coating the exposed head of mini-implants in order to avoid damage to the mucosa and/or help in the fixation of the springs and wires.
• Producing stops in orthodontic wire in biomechanics with self-ligating braces, preventing the wire from slipping and hurting the soft tissues.
• Producing stops in orthodontic wire aimed at helping guided orthodontic movements.
• Producing stops in orthodontic wire to lock open springs and prevent direct action on the tooth (bracket).
• In cases of dental traction (impacted teeth), it helps in fixing the ligature wire to the bracket. At the end where the ligature wire is attached to the orthodontic wire, Top comfort prevents the ligature from becoming loose from the nitinol wire using the property of the wire for the movement.
Step by Step
Place the lip retractor Arcflex (FGM) to open up the lips and cheeks and keep the area clean and dry.
Apply Top comfort to the region required, positioning the tip of the syringe on the bracket. There is no need for any prior treatment of the bracket, which should be dry.
Apply the product dispensing the desired amount so it does not touch the dental surface or orthodontic wire and obtain full coverage of the bracket (notice the excellent consistency of the product, which does not overflow when applied).
Light cure the resin for a period of 20 to 30 seconds.
Make sure the product covers the entire region to be protected and that it is completely cured.
To remove the product, use pliers and apply moderate force.
The product comes loose easily as a whole or in large pieces.
If necessary, use other instruments to help remove the product.
Yes, the product has immediate action, given that it covers the cutting areas and prevents possible injuries to the tissues.
Is it possible to apply the product on the same day as the installation of the orthodontic brackets?
Yes. Precisely on the first days after the installation of brackets when the mucosa tends to suffer irritation.
There is no need to apply adhesive or primer to the bracket beforehand. The bracket should be free from dirt (via prophylaxis) and dried in order to permit the correct installation of the resin material.
It is possible in cases where there is a hook in the previous bracket, provided that it is not in contact with the moving part of the braces (orthodontic wire)
Is there a problem in the use of elastic bands when the product is applied to the hook on the bracket?
Special care is necessary in the treatment stage where the elastic band is used, and the product should be applied so as not to impair the fit of the elastic on the hook. If it is not possible, the product should be completely removed from the hook in order to permit the installation of the elastic bands.
Is the product color stable? That is, will it turn yellow over time and impair the aesthetics of the smile?
No, the product is color stable and does not turn yellow over time.
Test samples were submitted to aging using thermal cycling (5°C/55°C – 10,000 cycles, equivalent to 2 years in the mouth) and immersed in coffee for 7 days.
The ΔE result was 0.95 after 10,000 cycles and 2.48 after 7 days in the coffee. According to Vitchi et al. (2004) a ΔE of 3.3 is considered the maximum clinically acceptable value for the color variation.
No, the product is easily removed under moderate pressure with orthodontic pliers. If necessary, a sickle probe may be use to aid the removal of the leftovers of the product.
How long does it take for the injury to subside after application of the product to the irritating area?
It depends on the petient, their habits, time and severity of the injury, among other factors. However, once the aggression to the soft tissue ceases (through coating with resin), the healing cycle can be expected to accelerate. The alleviation of the mucosa is immediate, as it prevents friction with the appliance.
As a resin product, the mechanical strength of Top comfort is greater than other similar products for the same purpose. The retention of the material to the appliance varies according to the technique and the patient’s habits etc. Usually the product resists monthly appointments, without requiring the patient to return to the clinic specifically for reapplication.
The product should not be exposed to moving parts (orthodontic wire) so as not to compromise the mechanics of the treatment, noting that it should not be applied to the rings of the orthodontic wire.
Information for the Professional
• Product for professional use only.
• Do not apply the products to orthodontic wires on the wire/bracket union so as not to interfere in the mechanics of the treatment.
• To apply Top comfort, the area should be dry and under relative isolation.
• The recommended light-curing time for this product depends on the power of the light emitted by the equipment. The power density of the light-curing unit is recommended to be over 400 mW/cm2. It is recommended that the patient and the dentist wear protective eyewear during the emission of blue light by light-curing unit.
• Do not keep Top comfort within reach of patients and children.
• Top comfort contains methacrylate monomers. Avoid using the product in patients with allergy to acrylates/methacrylates.
• Wear protective gloves when handling the product. If the product comes into accidental contact with the eyes or oral tissues, wash with plenty of water.
• Top comfort should not be ingested or inhaled. If so, seek medical attention immediately.
• After use, check if the cover of the syringe is closed correctly.
• For batch number and production and expiration date, see packaging.
• For your safety, keep the product in its original packaging.
• The packaging of the product should be closed immediately after use.
• Store the product in a clean and dry location in its original packaging.
vDo not expose the product to high temperatures or direct sunlight.
• Store the product at temperatures between 5-30ºC/ 41-95ºF.
• Do not freeze the product.
• The validity period of the product is 2 years from the production date.
• Do not use the product after its expiration date.
• Follow the legislation of your country for disposal of the product.
• Do not reuse empty packaging.
• Keep out of reach of children.
• Protect the product from external contamination.
• In the event of allergic reactions to the product, suspend its use.
• Top comfort is contraindicated in patients with allergies or hypersensitivity to any of the components of the formulation.