Reason for request

Inclusion

First assessment.

Favourable opinion for reimbursement in the adjuvant treatment of periodontal infections related to the development of bacterial plaque (gingivitis and/or periodontal disease), and in pre- and post-surgical care in odontostomatology in adults and children over 6 years old.

What therapeutic improvement?

No clinical added value compared to other mouthwash products containing chlorhexidine.

Role in the care pathway?

The aim of treatment is to prevent and control periodontal disease and to repair and/or regenerate damaged periodontal tissue (absence of inflammation, disappearance of periodontal pockets, etc.). The available treatment methods are:

  • mechanical treatments (supragingival scaling and scaling and root planing (SRP))
  • medicinal treatments (antibiotics, antiseptics)
  • surgical treatments.

The use of an antiseptic in dental practice is aimed at reducing microbial flora inside the mouth, as well as the cutaneous flora around the mouth liable to be a source of treatment-related infectious complications. Therefore the activity sought is primarily bactericidal and fungicidal. The majority of antiseptic products are bactericidal or fungicidal. The antiseptics used are chlorhexidine, iodine and quaternary ammonium compounds.

Role of the medicinal product in the care pathway:

This is a second-line treatment when tooth brushing alone is not indicated. The medicinal product ADONTEX (chlorhexidine digluconate), containing chlorhexidine as a mouthwash should be reserved for the population likely to benefit, i.e., individuals who cannot ensure adequate hygiene by manual tooth brushing alone:

  • in the early stages of treatment of gingivitis or periodontal disease,
  • on a temporary basis before and after surgery.

The summary of product characteristics (SPC) must be complied with: the duration of use is limited to 5 consecutive days.

 


Clinical Benefit

Low

The clinical benefit of ADONTEX (chlorhexidine digluconate) is low in the adjuvant treatment of periodontal infections related to the development of bacterial plaque (gingivitis and/or periodontal disease), and in pre- and post-surgical care in odontostomatology.


Clinical Added Value

no clinical added value

Considering:

  • the absence of data specific to the medicinal product ADONTEX (chlorhexidine digluconate), and, in particular, compared to other medicinal products containing chlorhexidine,
  • the medical need met by several therapeutic alternatives already available;

the Transparency Committee considers that ADONTEX (chlorhexidine digluconate) provides no clinical added value (CAV V) compared to the medicinal products containing chlorhexidine already available.


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