Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS)

Exclusion Criteria

• •1. Subjects with active periodontitis.
• •2. Presence of an acute infection in the oral cavity or upper respiratory tract.
• •3. Pregnancy or breastfeeding or planning to conceive from the clinical evaluation for enrollment up to 120 days after the end of the treatment.
• •4. Subjects must not be Smokers more than 10 cigarettes per day.
• •5. Presence of bleeding disorders or taking medications that affect blood clotting (e.g., coumarin-type drugs or platelet aggregation inhibitors).
• •6. Presence of systemic diseases that could affect periodontal health.
• •7. Patients with autoimmune diseases.
• •8. Known or suspected allergy to seafood products.
• •9. Psychiatric or behavioral disorders or substance abuse that would interfere with the necessary cooperation for the study.
• •10. Presence of infra-bony defects associated with pocket or papilla contraction and visible on X-ray as well as detectable on probing.