Sterify Gel Expanding the Boundaries of Care and Protection Meet the reduced bacterial contamination solution to support the healing process in the treatment of periodontal disease
Periodontitis is a chronic multifactorial disease that can lead to the destruction of the structures supporting the teeth.
Affects about
Leads to
70%
of the adult population 1
the destruction of the supporting apparatus of the tooth 1
When treating periodontal disease, Scaling & Root Planing (SRP) might currently require the addition of local antibiotic or local antibacterial agents 1
Sterify Gel is a medical device that offers a new approach to periodontal care.
Application Video
Mucoadhesive polymeric hydrogel in a pre-filled syringe for the treatment of periodontal disease 2
Polyvinyl polymers (10%): Physical occluding action
Hydroxytyrosol: Visco-modulator
Nisin: Preservative
Sterify Gel *
Magnesium Ascorbyl Phosphate: Gamma-protector
*Class III sterile, single-use, single-patient Medical Device, MDR Certified (CE 0426). 2
Graphic elaboration from ref. 2.
Sterify Gel provides a unique solution in the treatment of periodontal disease by preventing bacterial contamination and supporting tissue healing.
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 2
The occluding action at the level of the periodontal and peri-implant gingival pockets creates an environment unsuitable for bacterial growth and supporting the tissue healing process 2
Sterify Gel The main benefits
Reduction of bacterial contamination thanks to its occluding action
Support to tissue healing with significant and proven constant improvement of pocket depth
No antibiotics and no antiseptics but simultaneously acts as broad-spectrum antibacterial barrier, without generating resistance
No animal-derived components
Stable at room temperature with no need to manage the cold chain
Easy to use
Clinical Benefits
Sterify Gel and SRP demonstrated significant improvements in pocket depth, gingival recession, and clinical attachment level compared with SRP alone. 1 Study Design Prospective, randomized, controlled, and split-mouth investigation study, designed to assess the safety and efficacy of Sterify Gel as an adjunctive treatment following non surgical SRP for periodontitis in comparison with SRP alone 1
with moderate to advanced periodontal disease (stage III and IV) 34 patients
Randomization: one site for SRP alone (control), the other site for SRP with Sterify Gel (treatment)
CHANGES IN POCKET DEPTH, GINGIVAL RECESSION, AND CLINICAL ATTACHMENT LEVEL AFTER TREATMENT WITH STERIFY GEL COMPARED TO SRP ALONE 1
Change in pocket depth (PD) in millimeters at 1, 2, and 3 months vs. pretreatment conditions (n=34) 1
3
*
Sterify Gel + SRP only SRP
*
*
*p<0,05
2
Sterify Gel in conjunction with SRP consistently demonstrated a noteworthy improvement in PD, surpassing twofold enhancement compared to the control group throughout all follow-up intervals 1
1
0
1 Month
2 Months
3 Months
Figure 1a
Change in gingival recession in millimeters at 1, 2, and 3 months vs. pretreatment conditions (n=34) 1
0.0
Sterify Gel + SRP only SRP
-0.1
*p<0,05
-0.2
Minimal gingival recession was observed in all patients; however, patients treated with SRP only had a significant worsening compared to those treated with Sterify Gel at 2 and 3 months 1
-0.3
*
-0.4
*
-0.5
Figure 1b
1 Month
2 Months
3 Months
Change in clinical attachment level (CAL) in millimeters at 1, 2, and 3 months vs. pretreatment conditions (n=34) 1
Sterify Gel + SRP only SRP
3
*
*
*
*p<0,05
2
Significant advancements were observed in clinical attachment level (CAL), with the
1
treatment group exhibiting superior progress compared to the control group 1
0
1 Month
2 Months
3 Months
Figure 1c
REDUCTION OF BACTERIAL CONTAMINATION IN PERIODONTAL POCKETS FOLLOWING TREATMENT WITH STERIFY GEL 1
Bacterial contamination of specific bacteria strains in treated and control sites
Treated Group (Sterify Gel + SRP)
++
At 3 months follow-up, a “negative shift” to less bacterial positivity was observed in the
Pre-Treatment 3 Months
+
*p<0,05
treatment group , indicating a statistically significant trend toward reduced bacterial contamination 1
+/-
-
Aggregatibacter actinomycetem.
Prevotella intermedia
Parvimonas micra
Treponema denticola
Porphyromonas gingivalis
Tannerella forsythia
Fusobacterium nucleatum
Filifactor alocis
Figure 4a
Control Group (only SRP)
++
This trend was not observed in the control group who received SRP only, where no statistically significant differences were found 1
Pre-Treatment 3 Months
+
*p<0,05
+/-
-
Aggregatibacter actinomycetem.
Prevotella intermedia
Parvimonas micra
Treponema denticola
Porphyromonas gingivalis
Tannerella forsythia
Fusobacterium nucleatum
Filifactor alocis
Figure 4b
Bacterial contamination of specific bacteria strains was assessed through qPCR of samples obtained with probe collection in (a) treated and (b) control sites. On the Y-axis, “−” means negativity (no colony-forming units, CFU); “” means low positivity (up to 10 4 CFU); “+” means moderate positivity (between 10 5 and 10 6 CFU); and “++” means high positivity (between 10 6 and 10 7 CFU). “Aggregatibacter actinomycetem” is short for Aggregatibacter actinomycetemcomitans. Error bars show SEM. 1
STY-GEL0301 Sterify Gel 0,3 ml, 1 syringe
Components
Functional description
Polyvinyl polymers:
PVA (Poly Vinyl Alcohol) PVP (Poly Vinyl Pyrrolidone)
Physical occluding action
Excipients:
NIS (Nisin)
Preservative
HT (Hydroxytyrosol)
Visco-modulator Gamma-protector
MAP (Magnesium Ascorbyl Phosphate)
Aqueous Solution:
CBS (Citrate buffer solution)
Saline solution
References: 1. Levrini L, et al. Int J Dent. 2024;2024:3113479. 2. Sterify Gel - Instructions for use.
Start using Sterify Gel today and see the difference! HuFriedyGroup.eu/Sterify-Gel
Free Call: 00800 48 37 43 39 | Free Fax: 00800 48 37 43 40 E-Mail: info@hu-friedy.eu | Website: HuFriedyGroup.eu @HuFriedyGroupEurope
Hu-Friedy Mfg. Co., LLC. • European Headquarters • Lyoner Str. 9 • 60528 Frankfurt am Main, Germany • HuFriedyGroup.eu Sterify is a registered trademarks of Sterify Srl. All company and product names are trademarks of Hu-Friedy Mfg. Co. LLC., its affiliates or related companies, unless ortherwised noted. ©2024 Hu-Friedy Mfg. Co., LLC. All rights reserved. HFL-904EN/0924
Page 1 Page 2 Page 3 Page 4 Page 5 Page 6Made with FlippingBook Annual report