Evaluation of the clinical effectiveness and safety of the ETCHGEL medical device

Dear Sir/Madam,

Please take a few minutes

to complete the following survey.

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Doctor's personal details, professional licence number

Please provide your first name, surname and professional licence number. Please be advised that your personal data will not be collected, processed or disseminated without your knowledge and consent. It will be used solely to confirm that the survey has been completed by an authorised person.

Address of the dental clinic/ practice

Medical Representative Initials

If applicable

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Evaluation of the clinical effectiveness and safety of the ETCHGEL medical device

Since when have you been using the ETCHGEL (Arkona)?

Select one answer

For a few months

For 1-5 years

For 6-10 years

For over 10 years

Which volume of the ETCHGEL (ARKONA) do you purchase most often?

Select one answer

2,6 g

6,5 g

13 g

60 g with accessory syringes

How long does one syringe of ETCHGEL (ARKONA) usually last for you?

Please specify the number of hours, days, or patients

Please select the statements that you believe are true regarding the ETCHGEL (ARKONA).

Select one or more answers

It increases adhesion between tooth tissues and composite fillings

It improves the wettability of enamel by the bonding system

It is possible in every case where etching the tooth surface with a phosphoric acid-based preparation is required.

It allows the dissolution of mineral components and increases the roughness of the tooth surface.

The ETCHGEL (ARKONA) can be used for

Please select all the answers that you think are correct

chemically cured fillings

stabilization of teeth (permanent and temporary).

light-cured fillings

Fixed orthodontic appliances

Fissure sealants

Preparation of metal, composite, and acrylic surfaces of prosthetic work before using dual-cure cements.

For how many seconds (usually) is the ETCHGEL (ARKONA) left on the tooth surface before being rinsed off?

Please select the answer that is statistically the closest

10 s

20 s

40 s

60 s

longer than a 1 minute

It varies greatly (depends on the tooth/procedure

How do you assess the available weight variants of the etchgel (ARKONA), i.e., 2.6 g /6,5 g / 13 g / 60 g?

Select one answer

They are appropriate, I have no objections

I have no opinion

I would prefer a different amount. *

What other product size would you like?*

How do you assess the size and shape of the applicator included with the ETCHGEL (ARKONA)?

Select one size

It's suitable, I have no objections

I would prefer a different applicator (which one?*)

Which one?*

Have you ever used the ETCHGEL (ARKONA) on:

Select one answer in each line

YESNO

children aged 2 to 6

children aged 6 to 12

children over 12 years of age

adults (aged 18–65)

people aged 65-90

people over 90 years of age

pregnant or breastfeeding women

How would you assess the clinical effectiveness of the ETCHGEL (ARKONA) device in terms of the clinical indications listed in the Instructions for Use of the medical device?

1 - very low, 5 - very high

12345I do not use it for this indication

Etching the tooth surface for chemically cured restorations.

Etching the tooth surface for light-cured restorations

Etching the tooth surface for fissure sealants.

Etching the tooth surface for stabilization of teeth, either permanent or temporary

Etching teeth for orthodontic appliances

Preparation of metal, composite, and acrylic surfaces of prosthetic work before using dual-cure cements

Please indicate other indications*

Please provide your indications and rating from 1 to 5

How do you assess the etching effectiveness of the ETCHGEL (ARKONA) compared to other products of this type?

Select one answer

It etches better than other similar etchgels

It etches worse than other similar etchgels

It etches similarly to other etchgels available on the market

I have no comparison. I don't use any other etchgels.

It's hard to say

What are the main factors, in your opinion, that influence the proper etching process of the tooth surface?

You can select up to 3 answers

Follow the manufacturer's recommendations described in the product's instructions for use.

Ease of working with patients

Doctor's experience and skills

Preparation of the treatment surface (isolation from saliva, blood and other contaminants)

Quality of eatchgel used

Ease of rinsing the etchgel from the tooth surface

Etching time

Others*

Which other factors, in your opinion, that influence the proper etching process of the tooth surface?*

How would you assess the following functional characteristics and features of the ETCHGEL (ARKONA)?

(1 – very low, 5 – very high)

12345

Quality of the surface after etching

Etching speed

Uniformity / homogeneity of the etchgel

Effectiveness of etching

Etchgel color

Accuracy of etchgel coverage on the tooth surface (no air bubbles or inconsistencies)

Versatility (the ability to use it for various procedures)

Ease of gel application

Precision of material dosing

Ease of rinsing the gel from the tooth surface (no residue or remnants)

No staining of the tooth surface

Ease of removing etchgel residues into the suction system of the dental unit

Ability to use the entire contents of the packaging

Packaging ergonomics (shape, size, convenience)

Legibility of information on the label

Durability of packaging (syringe, applicator)

Packaging aesthetics

Overall material quality

Unit package price

How do you assess the consistency of the ETCHGEL (ARKONA) in the tooth etching procedure during:

Select one answer in each line

Too fluidOptimal consistencyToo thickI have no opinion

Filling cavities using chemically and light-cured materials

Fissure sealing

Stabilization of teeth using temporary or permanent splints

Bonding of fixed orthodontic appliances

Preparation of metal, composite, and acrylic prosthetic work for cement application

Other procedures*

Please provide your indications and rating from 1 to 5

How would you assess the information on the ETCHGEL label or in the instructions for use (indications, method of use, contraindications, side effects, warnings, etc.), i.e. is it complete, sufficient and understandable?

The answer NO should be justified by explaining what information is missing or unclear.

YES

NO*

The answer NO should be justified by explaining what information is missing or unclear.*

Has it ever happened during your professional practice that the ETCHGEL (ARKONA):

Select one answer in each line

YESNO

had contact with your eyes or the patient's eyes

was swallowed by the patient

was aspirated into the patient's respiratory system

had accidental contact with skin or soft tissues of the mouth

clearly changed colour in syringe (discoloured)

changed consistency, became thinner / thicker

caused an allergic reaction

did not etch the surface

Have you ever filed a complaint about it?

Showed incompatibility with another material

Dried out in the syringe

Was impossible to rinse off the tooth surface

If the ETCHGEL (ARKONA) caused an allergic reaction, please specify the type of reaction*

Have you ever observed any adverse effects after using the ETCHGEL (ARKONA)?

The answer YES must be explained. What adverse reactions have been observed?

YES*

What adverse reactions have been observed?*

Do you consider ETCHGEL (ARKONA) to be safe for the clinical indications described in the instructions for use?

The answer NO should be explained.

YES

NO*

Why not?*

Would you recommend the ETCHGEL (ARKONA) to another dentist?

Select one answer

YES

Do you have any comments, suggestions, ideas or concerns regarding the ETCHGEL (ARKONA) medical device that would help us improve our product?

Where do you usually obtain information about ARKONA products?

Select one or more answers

ARKONA sales representative

Distributor's sales representative

From the ARKONA website

From the distributor website

From social media

From promotional brochures

From the distributor's call centre

Others

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