Clinical trials of toothpaste PRANOYA

RDA (RELATIVE DENTIN ABRASION)

ISO 11609 Annex B

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CONFIRMED STANDARDS AND METHODS

THE STUDY IS CONDUCTED, PROVEN AND COMPLIANT WITH ISO 11609 STANDARDS:Purpose: To use acellular samples of human dentin as a test substrate to determine the RDA of Product: PRANOYA Toothpaste for Cosmetic Dentistry and Natural Teeth against the ISO 11609 reference index (Annex B).Conclusion:- The abrasivity of the PRANOYA toothpaste formulation evaluated in this study was well below the upper safe limit of ISO 11609.- PRANOYA toothpaste formulation has passed ISO 11609 safety requirements.At 2000 stokes it has a low RDA, at 4000 stokes (3rd standard and latest version) it has an RDA of 104 (ideally 100).

MICROBIOLOGICAL TEST

The study is accredited by RENAR and ILAC-MRA

CONFIRMED STANDARDS AND METHODS

CHALLENGE TEST

Accredited laboratory

Physical chemistry, PRANOYA ingredients

CONFIRMED STANDARDS AND METHODS

ISO 11930 standard

PHYSICAL CHEMICAL TESTS

Accredited laboratory

Physical chemistry, PRANOYA ingredients

CONFIRMED STANDARDS AND METHODS

PB-155 ed.I of 02.05.2012 - CONFORMABLEPB-234 ed. I of 03.10.2013r. - CONFORMABLEBrookfield DVIII ultra - CONFORMABLE

ISO 6658 standard

DERMATOLOGICAL COMPATIBILITY TEST

THE STUDY IS CARRIED OUT, PROVED AND IN ACCORDANCE WITH THE STANDARDS:Regulation of European Parliament of Council (EC) No. 1223/2009 of 30 November 2009 on cosmetic products.Cosmetics Europe - The Personal Care Association (previously COLIPA) Guidelines “Product TestGuidelines for the Assessment of Human Skin Compatibility 1997Cosmetics Europe - The Personal Care Association (previously COLIPA) Guidelines for the Evaluation of the Efficacy of Cosmetic Products 2008. The dermatological study was performed on a sample of 50 people of which 25 with a negative allergen history and 25 with a positive allergen history.Two assessments were made at 48 and 72 hours, respectively.The result of the study proved 0 (zero) allergenic reactions in all subjects tested.

STABILITY AND COMPATIBILITY IN VIEW OF DETERMINATION OF MINIMUM DURABILITY

THE STUDY IS CARRIED OUT, PROOF AND IN ACCORDANCE WITH THE STANDARDS:Regulation of European Parliament of Council (EC) No. 1223/2009 of 30 November 2009 on cosmetic products.“Guidelines on stability testing of cosmetic products, March 2004” (CTFA)Strictly tested with fluctuations 70 days.

Human Clinical Trials - UNDER DENTIST SUPERVISIONFor Cosmetic Dentistry and Natural Teeth

THE STUDY IS CARRIED OUT, PROVED AND IN ACCORDANCE WITH THE STANDARDS:Regulation of European Parliament of Council (EC) No. 1223/2009 of 30 November 2009 on cosmetic products.Cosmetics Europe - The Personal Care Association (previously COLIPA) Guidelines “Product TestGuidelines for the Assessment of Human Skin Compatibility 1997Cosmetics Europe - The Personal Care Association (previously COLIPA) Guidelines for the Evaluation of the Efficacy of Cosmetic Products 2008 The clinical study was performed over a period of 28 days with a sample of 20 people aged 21 to 67 years and multiple dental problems: yellow teeth, discoloration, caries, dental plaque, dental sensitivity, recent dental cosmetic work (prosthetic works: dental veneers and crowns)

Conclusions and results:

It was tested under supervision dentist ;The results of the tests concluded that the product is very good tolerated by all tested subjects, as a result there are no contraindications;Confirmed properties of the product following the clinical trial:

- Cleans teeth efficiently- Gently brush your teeth- Restores natural white and shine- Visibly removes dental plaque- Provides a feeling of cleanliness after using the product- Refreshes the breath- Helps maintain oral hygiene- Provides a feeling of freshness- Suitable for everyday use

SAFETY EVALUATION OF PRODUCT

THE STUDY IS CARRIED OUT, PROVED AND IN ACCORDANCE WITH THE STANDARDS:Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products ANNEX I