AVAILABLE FORMATS: Sterify Gel: 0.3 ml, 0.5 ml or 1 ml pre-filled syringe of polymer hydrogel, in single or multi-pack. Sterify Gel HM (High Mucoadhesivity): 0.3 ml, 0.5 ml or 1 ml pre-filled syringe of high mucoadhesivity polymeric hydrogel, in single or multi-pack.
WARNINGS: Sterify Gel is biocompatible, phthalates and latex free.
Hydrogel based on polyvinyl polymers, nisin, hydroxytyrosol and magnesium ascorbyl phosphate from the Sterify line has a shelf life of 3 years from the date of sterilization. The shelf life is guaranteed only if the devices are in original and undamaged packaging and stored according to the instructions provided by Sterify S.r.l. If the package is found to be open or damaged, do not use the device but return the package to the manufacturer. Do not use Sterify Gel after the expiration date. The expiration date refers to the product in unopened packaging and properly stored. The materials constituting the package do not require special disposal conditions. The use of the product mixed directly with drugs (e.g., antibiotics) has not been tested. Sterify Gel has not been tested on pregnant patients. Any serious incidents occurring in connection with the Sterify Gel device should be reported to the manufacturer and the appropriate authorities. The manufacturer disclaims any liability in relation to damage caused by use of the device outside its intended purpose and on patients who are not indicated for treatment. Sterify Gel is a Class III sterile, single-use, single-patient medical device; it can neither be reused nor resterilized. Any residual unused product should not be stored and used in other surgeries or for other patients and should be disposed of as contaminated hospital waste according to the regulations in effect at the dental office. In the event that the disposable device is mistakenly reused, in addition to affecting its performance, possible patient infections could occur due to lost sterility and/or possible contamination of the device itself. Failure to do so implies a different use than that intended by the manufacturer, which can no longer guarantee the conditions of hygiene, functionality and safety once the package has been opened. Sterify Gel is intended for topical gingival and bone use only. Do not use systemically. Instructions for patients: It is recommended not to eat, rinse or gargle with mouthwash for two hours after treatment. Follow the oral hygiene instructions provided for two days after treatment and do not use interdental cleaning aids such as dental floss or pipe cleaners. Patients should be advised to continue necessary oral hygiene practices designed to control reinfection. No restrictions on eating habits are necessary. LIMITATIONS AND ATTENTIONS: Read the instructions carefully before use. MECHANISM OF ACTION: Due to its specific visco-elastic and mucoadhesive properties, Sterify Gel easily penetrates into the deepest and hard-to-reach areas of periodontal and peri-implant pockets, adhering to the gingival tissue, alveolar bone or root and dental implant surfaces, providing complete coverage of the pockets. The effect of Sterify Gel is promoted by a physical mechanism of action. After scaling or root planing and biofilm removal, the gel is applied to the gingival pocket, where it acts primarily as a filler to restore volume, physically preventing bacteria from entering and reinfecting the pocket. Sterify Gel can thus mechanically protect the treated pockets and alveolar bone, promoting tissue healing. EXPECTED CLINICAL BENEFITS: Although scaling and root planing is considered a gold standard treatment for periodontitis and peri-implantitis, exposure of the gingival pockets can allow bacteria to recolonize the tissues promoting new inflammation that can worsen the clinical picture. Sterify Gel may find useful application in cases of stage III and IV periodontal disease as an adjunctive treatment following scaling and root planing to improve and accelerate healing parameters and prevent inflammation and recurrent infection. In addition, antimicrobial control action prevents the use of antibiotics and the risk associated with antibiotic resistance. Such control of periodontal disease also allows the retention of patients who cannot undergo surgical treatment. The expected clinical benefits are as follows: - Improved outcome of the nonsurgical procedure of plaque removal and root planing in stage III and IV periodontal disease in terms of increased success of the deep hygiene procedure and limitation of disease recurrence; - Mechanical protection of the periodontal pocket to prevent bacterial recolonization after deep hygiene procedure; - Mechanical protection of the periodontal pocket to promote healing of gingival and alveolar tissues after deep hygiene procedure; - Reduction or elimination of surgical procedures for the treatment of stage III and IV periodontal disease, especially in the maintenance of patients who cannot undergo surgery (e.g., patients on bisphosphonate therapy, defected, etc.); - Reduction or elimination of local and/or systemic antibiotic therapies in individuals with periodontal disease undergoing a deep hygiene procedure; - Non-invasive treatment of periodontal pockets without the use of disinfectants that can cause staining of dental elements and mucosal irritation or hypersensitivity. INSTRUCTIONS FOR USE: The product is ready to use. After the mechanical instrumentation procedure on the root surface and after washing and drying the site, Sterify Gel should be applied directly inside the periodontal or peri-implant pocket, from the depth of the pocket to the gingival margin. After removing the cap, screw a sterile cannula or needle with luer lock attachment preferably with a rounded tip of a caliber appropriate for the specific use (diameter 0.6 mm or greater, not included in the sales package) to the Sterify Gel syringe. Proceed with implantation aseptically: gently press the syringe plunger so that the gel is applied to the bottom of the pocket; press until the gel emerges or becomes visible at the gingival margin. Once implanted, Sterify Gel undergoes a process of progressive imbibition upon contact with biological fluids, with gradual physical removal from the implant site and degradation over 14 to 30 days, such that its subsequent removal at the dental office is unnecessary. The volume of Sterify Gel is sufficient for filling several pockets, so that it can be applied simultaneously in all periodontal and peri-implant pockets to be treated. If the depth of the gingival pocket is greater than 5 mm, a subsequent application of Sterify Gel after 3 months may be indicated.
Sterify S.r.l. Via Nizza, 262/1 – 10126 Torino (TO), Italy +39 011 2173 3224 – info@sterify.it – www.sterify.it
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