Cavex Bite&White
Aligner
Whitening Pen

An aligner treatment is an orthodontic procedure that uses clear, custom-made plastic trays (aligners) to move teeth into the desired position. Unlike traditional metal braces, aligners are virtually invisible and can be removed while eating or brushing, making them easier to use in daily life.

An aligner treatment can cause sensitivity when switching to a new aligner, typically every one or two weeks. This occurs because new forces are applied to the teeth, which may result in sensitivity. If this happens, we recommend pausing the whitening treatment and resuming it after one or two days.

Tooth discoloration can have intrinsic and/or extrinsic causes. Intrinsic discoloration is caused by pigment particles naturally embedded in the enamel and dentin. Extrinsic causes involve stains on the tooth surface.
The gel used in the Cavex Bite&White Aligner Whitening Pen contains 3% hydrogen peroxide in the form of ‘Hydrogen Peroxide Superior’ (HPS) and addresses both intrinsic and extrinsic discoloration. This proven whitening agent penetrates the enamel and breaks down discolored molecules by forming radicals (small energy particles).

A whitening treatment should always be done under the supervision of a dentist. Whitening under professional supervision is safe and effective. Clinical studies support the safety and efficacy of at-home whitening gels when used correctly. Tooth sensitivity and gum irritation may occur during whitening treatments, but these effects are short-lived and have no long-term consequences. Cavex Bite&White is developed and produced in compliance with strict European cosmetic regulations and has been thoroughly tested and evaluated.

In short, from the dentist and dental suppliers. Cavex Bite&White may only be sold by dentists. A consultation with a qualified dentist is recommended before starting the whitening procedure to rule out any underlying health issues.
According to the European Cosmetics Regulation 1223/2009, teeth whitening products containing between 0.1% and 6% hydrogen peroxide can only be sold by dentists. Higher concentrations are not allowed to be sold in Europe.

The purpose of this regulation is twofold. Firstly, it is designed to reduce the risk of damage to teeth and gums that could result from using teeth whitening products releasing more than 6% hydrogen peroxide. Secondly, the regulation aims to ensure that whitening procedures using significant amounts of hydrogen peroxide are supervised by a professional with the necessary knowledge and training to ensure safe and effective treatment.

Cavex Bite&White is developed in full compliance with this European legislation, and Cavex fully supports the enforcement of this law.

With the Cavex Bite&White Aligner Whitening Pen, we recommend whitening your teeth two hours before bedtime. Apply the whitening gel to your teeth and wear the aligner over it. Let it work for 20 minutes to 2 hours, then remove the aligner and rinse your mouth. Afterward, you can place the aligner (without whitening gel) back into your mouth as part of your aligner treatment.

During sleep, there is sufficient time for re-mineralization after whitening.
Immediately after whitening, your teeth are more sensitive to staining from foods or drinks. The structure of the teeth is “open,” so consuming products with dyes (red wine, coffee, tea, soda, smoking) that could stain is discouraged.
Everything that can stain a white T-shirt can also stain your teeth. Since no food is consumed while sleeping, there is no risk of staining.

We recommend wearing the aligner for 20 minutes to 2 hours.

The procedure can be repeated as often as needed until the desired result is achieved. The Aligner Whitening Pen (6 ml) contains enough material for approximately 30 days of whitening.

The aligner, combined with the thixotropic whitening gel, ensures the gel does not come into contact with areas prone to irritation, such as your gums. Mild sensitivity is possible and varies from person to person.

An exact indication cannot be given, except that the teeth will become whiter! The number of shades lighter varies significantly from person to person. It also depends on the nature and current state of your teeth, the type of staining, and the user’s motivation (discipline).

Like all products, Cavex Bite&White has an expiration date. The Aligner Whitening Pen can be stored for at least three years, provided the cap is securely placed on the brush pen.

Teeth can still be whitened with restorations present in the mouth; however, these restorations will not be affected by the whitening gel. A solution is to replace the restorations after achieving the desired whitening result. The patient and dentist always make this decision together.

Teeth whitening should only be performed under the supervision of a dentist. Whitening under controlled dental supervision is safe and effective. One major reason why many whitening treatments can be harmful to your teeth is the pH value. Many whitening materials have a low pH, leading to the saying, “beauty is pain.” Cavex Bite&White is pH-neutral and therefore safe and pain-free to use.
Clinical studies support the safety and effectiveness of at-home whitening systems when they are pH-neutral and used correctly. Tooth sensitivity and soft tissue irritation may occur during the whitening treatment, but these effects are short-lived.

No, the whitening gel does not contain fluoride. The composition of the gel minimizes demineralization, making the addition of fluoride unnecessary.

The claim of a lamp is that it accelerates the effect of peroxide. However, literature does not prove any effect of a lamp in speeding up teeth whitening. High-intensity light may lead to a few degrees of temperature rise, which can accelerate the breakdown of peroxide. Numerous studies indicate that the faster the whitening process occurs, the faster discoloration can reappear. Additionally, prolonged exposure to the heat from light on the teeth can potentially harm the dental pulp.

Based on numerous studies, the Scientific Committee on Consumer Products (SCCP) conducted a safety evaluation in 2011 regarding the use of hydrogen peroxide in oral hygiene and teeth whitening products. As in many risk assessments, the SCCP used the Margin of Safety (MOS) to determine the maximum concentration considered safe.
MOS values below 100 are deemed unsafe by regulatory authorities.

Safety Margin Formula:
Safety Margin = NOAEL (mg/kg body weight/day) ÷ Exposure (mg/kg body weight/day)

• NOAEL for hydrogen peroxide:
  A 100-day study showed a significant reduction in plasma catalase levels at higher doses. Based on this, the NOAEL (No-Adverse-Effect-Level) was set at 20 mg/kg bw/day.

Estimated daily exposure (average 60 kg body weight):

• Toothpaste = 480 mg/day with 0.1% hydrogen peroxide
  0.48 mg/60 = 0.008 mg/kg bw/day → MOS = 20/0.008 = 2500 = SAFE

• Mouthwash = 3000 mg/day with 0.1% hydrogen peroxide
  3 mg/60 = 0.05 mg/kg bw/day → MOS = 20/0.05 = 400 = SAFE

• Tooth whitener = 200 mg gel/tray/day with 6% hydrogen peroxide
  12 mg/60 = 0.2 mg/kg bw/day → MOS = 20/0.2 = 100 = SAFE

• Tooth whitener = 200 mg gel/tray/day with 35% hydrogen peroxide
  70 mg/60 = 1.17 mg/kg bw/day → MOS = 20/1.17 = 17 = UNSAFE

Conclusion:
Based on the MOS evaluation, the SCCP determined that 6% hydrogen peroxide (16% carbamide peroxide) is the maximum allowable concentration.

References:
SCCP report 18/12/2007 – in the dossier

There are two possible reasons:

1. Fluorosis: This is one reason why a dentist should evaluate whether a whitening procedure can proceed. Fluorosis might have been present but unnoticed. It is a developmental disorder of tooth enamel caused by excessive exposure to high fluoride concentrations during tooth development, not by whitening products.

2. Dehydrated teeth: Overuse of peroxide gel with too high a concentration can dry out the teeth. But don’t worry; these spots will disappear within a few days. This is referred to as the “chicken bone effect.” If you dry a chicken bone for a few days, it will turn white. Place it in water, and it will return to its original color. The likelihood of this occurring with moderately dosed whitening gels like “Cavex Bite&White” is minimal.

For pregnant women and breastfeeding mothers, it is recommended to consult a doctor to determine if it is advisable.