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

Dear Sir/Madam,

Please take a few minutes

to complete the following survey.

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Please be informed that your data obtained as a result of previous contacts with ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk (hereinafter referred to as ARKONA) is stored in the ARKONA Contractor Database, which is the administrator of your personal data. Details regarding ARKONA's personal data protection policy are available at https://arkonadent.com/wp-content/uploads/2020/10/arkonadent.com-polityka-prywatnosci.pdf. If you would like to obtain detailed information about the rules and purposes of ARKONA's processing of your personal data, please contact us at the following e-mail address: polityka.prywatnosci@arkonadent.com or at the postal address Nasutów 99C, 21-025 Niemce, Poland.

Doctor's personal details, professional licence number

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

Address of the dental clinic/practice

Medical Representative's initials

If applicable

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

Since when have you been using the SHAPEDCHORDS medical device ?

Select one answer

For a few weeks or less

For a few months

For about year

For 2-5 years

For 5-10 years

For over 10 years

How often do you use the SHAPEDCHORDS in your practice?

Select one answer

Every day or almost every day

Once a week

Once every two weeks

Once a month

Once every few months

Once a year or less

How many (approximately) SHAPEDCHORDS have you used in your practice so far?

Select one answer

A few pieces

A dozen or so pieces

Several dozen pieces

Several hundred pieces

Which SHAPEDCHORDS variants do you use in your practice?

Select one or more answers

External SCHAPEDCHORDS

Internal SCHAPEDCHORDS

Do you think that the above-mentioned variants of the SHAPEDCHORDS are:

Select one answer

Sufficient

I have no opinion

Insufficient

How do you use the SHAPEDCHORDS product?

Select one answer

I do not divide the product, one SHAPEDCHORDS is enough for me to work on one patient.

I cut the SHAPEDCHORDS to the desired length and throw away the rest.

I always divide the SHAPEDCHORDS, there is generally enough to work on at least two patients.

I use it differently*

How do you use the SHAPEDCHORDS?*

For what clinical indications do you use the SHAPEDCHORDS medical device?

Please mark the indications for which you have used the product (you can mark any number of indications):

Stabilization of loosened teeth in the course of periodontal disease

Temporary tooth stabilization after trauma

Fixing the results of orthodontic treatment

Maintenance of interdental spaces before and during orthodontic treatment

Making adhesive splints using the patient's own tooth or modeling the tooth composite

Other*

For which other clinical indications do you use the SHAPEDCHORDS?*

Have you ever used the SHAPEDCHORDS medical device on:

Choose one answer in each line

YESNO

children aged 2 to 6

children aged 6 to 12

children over 12 years

adults (aged 18–65)

people aged 65-90

people over 90 years old

pregnant or breastfeeding women

How would you assess the clinical effectiveness of the SHAPEDCHORDS product 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 in this indication

Stabilization of loosened teeth in the course of periodontal disease

Temporary tooth stabilization after trauma

Fixing the results of orthodontic treatment

Maintenance of interdental spaces before and during orthodontic treatment

Making adhesive splints using the patient's own tooth or modeling the tooth composite

What other indications?*

Please provide your indications and evaluation on a scale of 1-5.

For what period do you estimate the durability of the SHAPEDCHORDS – how long does the work remain in the patient’s oral cavity?

Select one answer

Less than a month

A few months

For 1-3 years

For 4-7 years

For 7-10 years

For over 10 years

How do you assess the duration of work made with SHAPEDCHORDS in the patient’s oral cavity compared to other dental fibers?

Select one answer

It lasts for a shorter time than works made with other dental fibers

It lasts longer than works made with other dental fibers

It lasts comparably to works made with other dental fibers

It's hard to say

What are the main factors, in your opinion, that most affect the durability of fiber splints in the patient’s oral cavity?

Select up to 3 answer

Tooth surface preparation (cleaning, etching)

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

The effectiveness of the bonding system

The quality of the fiber used

The quality of the composite used

Ease of cooperation with the patient

The curing/polymerization time

Type and power of the curing light

Following the manufacturer's recommendations described in the product's instructions for use

Doctor's experience and skills

Patient's care for oral hygiene

How do you assess the following usability features and properties of the SHAPEDCHORDS?

(1 – very low 5 – very high)

12345

Ease of cutting/trimming SHAPEDCHORDS

Ease of adapting SHAPECHORDS to the shape of the teeth

The time required to complete work with SHAPEDCHORDS

The possibility of using the entire fiber

The mechanical strength of the restoration with the fiber

The aesthetics of the restoration with the fiber

Compatibility of SHAPECHORDS with other materials, e.g., bonding systems, composites, resins.

Durability of work with SHAPEDCHORDS in the oral environment

Product compliance with the Manufacturer’s description

Readability of information on the label

Packaging durability

Packaging aesthetics

Overall material quality

Unit package price

How would you assess the information on the SHAPEDCHORDS 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*

What information is missing or unclear?*

Has it ever happened during your professional practice that the SHAPEDCHORDS medical device:

Select one answer in each line

YESNO

had contact with your eyes or the patient's eyes

caused an allergic reaction

was swallowed by the patient

was aspirated into the patient's respiratory system

required filing a complaint for any reason

had accidental contact with skin or soft tissues of the mouth

has demonstrated incompatibility with other materials (e.g. binding system, etc.)

clearly changed colour (discoloured)

If SHAPEDCHORDS has caused an allergic reaction, please specify the type*

Have you ever noticed any adverse reactions after using SHAPEDCHORDS products?

The answer YES must be explained. What side effects have been observed?

NIE

YES*

What adverse reaction have been observed?*

Do you consider SHAPEDCHORDS to be safe in terms of the clinical indications described in the instructions for use?

The answer NO should not be explained

YES

NO*

Why not?*

What factors do you usually consider or would consider when deciding to purchase dental fibres?

Select one answer

Fibre price

Available technical and literature data

Material quality

Functional characteristics of the material

Your own skills in working with a specific type of fibre

Did the use of SHAPEDCHORDS in your case require practical training prior application?

Select one answer

The use of SHAPEDCHORDS did not require additional training; the description of its use provided in the manual was sufficient

The use of SHAPEDCHORDS required practical training

Practical training in the use of SHAPEDCHORDS is welcome, but was not essential.

Using SHAPEDCHORDS required training, but it was not available.

I would like the training, I would gladly take advantage of training even now

Would you take part in training on the use of SHAPEDCHORDS?

Select one answer

YES, I would love to

YES, if it were free

NO. I no longer need it

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

Please write down your comments/ideas or write ‘NO’.

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 industry-specific websites

From promotional brochures

From trade fairs and exhibitions

From social media

From the distributor's call centre

From scientific literature/publications

From conversations with other doctors

Others

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