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View corresponding page on italian website CURASEPT.IT

CHLORHEXIDINE: GOLD STANDARD AND ADS

Chlorhexidine is a molecule that was first synthesised in 1950 as an antiseptic for the mucosas, the skin, and wounds, and used as a preservative in ophthalmic pharmaceutical formulas.

In dentistry, Chlorhexidine has been in use for over thirty years and is still considered the gold standard recognised worldwide for controlling plaque and preventing gingivitis. In fact, Chlorhexidine can not just break down the bacterial film, but also inhibits its formation and stratification. Moreover, it has a broad spectrum of action that makes it effective against Gram+ and Gram-, viruses, and mycetes; it has antifungal properties and does not induce bacterial resistance phenomena in the oral cavity. Lastly, Chlorhexidine’s plus points include substantivity, i.e. the property that allows it to remain bound to hard and soft tissues for 8/12 hours, thus making for long-term action and efficacy throughout the day.

SIDE EFFECTS OF CHLORHEXIDINE

However, as well as many advantages, chlorhexidine has a tedious side effect: it triggers chemical reactions in the oral cavity that are responsible for the discoloration of the surface of the teeth, thus negatively affecting the patient’s compliance with the treatment. This aesthetic alteration has, in the past, led professionals to prescribe chlorhexidine with reservations, and has compromised compliance in the use of this active principle by the patients. 

This is why the launch of Curasept ADS marks an epic shift in the history of oral care: a line of products which combine the effectiveness of chlorhexidine with ADS (Anti Discoloration System) that can limit discoloration, preserving the effects of the treatment.

QUESTIONS AND ANSWERS TO UNDERSTAND ADS

Does ADS reduce the efficacy of Chlorhexidine?

The main causes of tooth discoloration are two chemical reactions that are catalysed by Chlorhexidine inside the oral cavity: the Maillard reaction and the protein denaturation reaction. ADS, which contains Sodium Metabisulfite and Ascorbic Acid, intervenes by interrupting the sequence of reactions that leads to the formation of yellow/brown precipitates deriving from these reactions.

How does ADS act?

The main causes of tooth discoloration are two chemical reactions that are catalysed by Chlorhexidine inside the oral cavity: the Maillard reaction and the protein denaturation reaction. ADS, which contains Sodium Metabisulfite and Ascorbic Acid, intervenes by interrupting the sequence of reactions that leads to the formation of yellow/brown precipitates deriving from these reactions.

Does ADS reduce the efficacy of Chlorhexidine?

No: the success of ADS consists precisely in the ability to interrupt the chemical reactions responsible for discoloration, without interfering with the activity of chlorhexidine.

Are there studies that support the efficacy of ADS?

Yes, many. The results of the systematic review carried out with the goal of establishing whether the combination of Chlorhexidine and ADS is effective in reducing dental discoloration while maintaining the anti-plaque and anti-gingivitis action of Chlorhexidine were presented during the EuroPerio event that took place in Amsterdam in June 2018. The authors of this systematic review (Van Swaaij Bwm, Van Der Weijden Ga, Bakker Ewp, Slot De – 2018), which is the highest degree of scientific evidence:

  • analysed 87 publications
  • selected 11 articles for the review
  • made 14 direct comparisons, of which 9 were included in the final meta-analysis

and concluded that the addition of ADS to a mouthwash containing Chlorhexidine significantly reduces discoloration and does not influence the action of Chlorhexidine in controlling gingival inflammation and plaque indices. This literature review suggests that the combined use of Chlorhexidine + ADS should be taken into consideration due to its effectiveness against plaque and in reducing gingival inflammation, which is combined with an anti-discoloration action.

Could other products interfere with the efficacy of Chlorhexidine?

Yes: when discussing Chlorhexidine it is important not to think just of rinsing with a mouthwash, but to also focus on the choice of the right toothpaste.
Many toothpastes contain salts, including carbonates, phosphates, anionic surfactants (e.g., SLS or SLES), excipients that bind to the two positive charges of the Chlorhexidine molecule, activating it and partly or totally compromising its efficacy. This is why it is important to choose a toothpaste studied to obtain 100% of the performance of chlorhexidine-based treatments, such as all Curasept ADS toothpastes.

THE FIRST NON-STAINING CHLORHEXIDINE

The first Curasept mouthwashes and toothpastes with Chlorhexidine featuring A.D.S.® – Anti Discoloration System, an innovative, patented, and clinically tested system that reduces the appearance of yellow-brown spots on the teeth, which is the main side effect of Chlorhexidine.

A.D.S.® inhibits the two chemical reactions leading to pigmentation, without affecting the antiplaque activity of Chlorhexidine. 

Curasept ADS

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Quality Policy

The Quality for CURASEPT S.p.A. is an essential condition to put itself successfully on the market, considering its characteristics and evolution.

The development of the Company and its profit are insured by the continuous search for quality towards excellence through the continuous improvement of its processes and the search for partners with quality systems adapted to our standards.

The Company aims to increase the customer satisfaction through the application of its Quality Management System, including the processes to improve the system and to ensure the compliance with the customer and applicable regulatory requirements.

For this purpose, the Company performs specific risks and opportunities assessment activities, connected to the context, stakeholders and related objectives, in order to identify the areas of system improvements and to define the appropriate actions for the risk control and mitigation and strengthening of its Quality System.

The starting point for the implementation of this policy is the pursuit of the following objectives:

  • Define and implement a Quality Management System according to 9001:2015+A1:2024 e UNI CEI EN ISO 13485:2021 regulation, as Manufacturer of Medical Devices;
  • Define and implement a system of procedures and operating instructions in harmony with the Directive 93/42/CEE, the Regulation (UE) 2017/745 and the Regulation (UE) 2023/607 for the applicable parts and subsequent changes and integrations, which satisfy the essential requirements set out in Annex I;
  • Define and implement a system of procedures in harmony with the Directive 2010/84, the Regulation 1235/2010, the Implementation Regulation n. 520/2012 and in accordance with the objectives of “module I – “Good Vigilance Practices” (GVP);
  • Establish and formalize the business organizational structure with the subdivision into areas of competences;
  • Clarify roles and responsibilities of business functions;
  • Define strategies and objectives and assign human and material resources for their achievement;
  • Define accurately business processes and related performance factors;
  • Ensure compliance with qualitative, quantitative and temporal requirements;
  • Constantly monitor the level of adequacy of the system with reference to regulations and laws;
  • Promote initiatives in order to improve the process of motivational and professional growth of human resources, considered as critical resources for future business developments;
  • Ensure the commitment to the satisfaction of requirements and the maintenance of effectiveness of the Quality Management System.

These objectives can be realized thanks to the involvement of the whole Company personnel.

In particular, the Managers of each Function provide their contribution so that the suggested improvements can be proposed to the General Direction, so that the Quality Policy can be a priority element in the choice of business qualitative and organizational strategies.

The involvement of the whole personnel in the improvement of internal and external processes should be aimed at reducing non-compliance and internal and external costs of non-quality; for this reason all employees should feel themselves committed in pursuing this policy.

Training courses, for all business levels, are promoted and planned by the General Direction in order to keep the personnel constantly up to date on the improvements performed for the processes.

The Quality Manual, which is distributed via the SistemaQualità to all process managers and the General Director, should represent a work tool for all Managers and their personnel for the implementation of the Quality Policy.

April 2025

General Direction