6
International Journal of Dentistry
its safety. In addition, our fi ndings demonstrate that treat- ment with Sterify Gel in conjunction with SRP resulted in signi fi cant improvements in periodontal PD, gingival reces- sion, and CAL, compared with SRP alone; while no signi fi - cant differences were observed in plaque and bleeding index and tooth stability between the two groups. Notably, the “ negative shift ” toward less bacterial positivity in the treated group suggests the ability of Sterify Gel to protect gingival pockets from bacteria recolonization, which could contribute to the long-term stability of periodontal health. These posi- tive results may be attributed to the mechanical action of occlusion exerted by the hydrogel, which creates a barrier to bacterial recolonization, as well as the antioxidant and bacteriostatic properties of HT and nisin, respectively. Indeed, HT is a naturally occurring antioxidant found in olive oil that garners attention due to its potential health bene fi ts [17, 18]. Acting as a free radical scavenging agent, a tailored concen- tration of HT can prevent radiation-induced cross-linking and viscosity increase of hydrogels [20], improving hydrogel design and structure. Similarly, the bacteriostatic properties of nisin [19] fur- ther improved the stability of the implanted hydrogel, pro- tecting it from bacterial degradation. HT and nisin may also directly enhance periodontal pocket healing through their properties mentioned above. Moreover, MAP, which is a stable water-soluble form of vitamin C, is used to protect HT from degradation during gamma ray sterilization, acting therefore as a protectant agent in the gel formulation [21]. Using medical devices such as Sterify Gel may represent a promising strategy to overcome the limitations of traditional treatment approaches for chronic periodontitis, such as SRP. While SRP effectively reduces periodontal symptoms, its lim- ited ef fi cacy in deeper and anatomically complex pockets hinders complete bacterial removal, and reinfection may occur rapidly and more severely [6]. The emergence of anti- microbial resistance further highlights the need for new approaches to periodontal disease management, and Sterify Gel may represent a viable alternative to antibiotic-based treatments. Lately, intraperiodontal pocket administration of biomaterials and drugs has emerged as an optimal strategy for the local treatment of periodontitis [22]. In a study eval- uating the clinical effects of SRP combined with local admin- istration of hydrogen peroxide gel and doxycycline using customized prescription trays for the treatment of chronic periodontitis, the authors found that the combined treatment resulted in signi fi cant reductions in PD compared to SRP alone [23]. Another study aimed to compare the ef fi cacy of subgingivally administered xanthan-based chlorhexidine gel versus 0.2 % chlorhexidine irrigation following SRP in the treatment of chronic periodontitis, showing that both groups exhibited statistically signi fi cant improvements in clinical parameters compared to SRP alone [24]. Another research group evaluated the adjunctive effect of hyaluronic acid (HA) gel in treating residual periodontal pockets over 12 months with no statistically signi fi cant improvement compared to placebo treatment [25]. Our study highlights the potential of Sterify Gel as a novel antibiotic-free adjunct therapy for chronic periodontitis and its role in reducing reliance on
antibiotics. Although comparisons with other devices have not yet been made, the innovative formulation of Sterify Gel may overcome the limitations of disinfectants such as chlor- hexidine that can cause discoloration of teeth and gum irritation [26]. Limitations of our study include the relatively small sam- ple size, the short follow-up period of 3 months, and the single-center nature, which may limit the generalizability of our fi ndings. Future studies with larger sample sizes, lon- ger follow-up periods, and multicentric framework are nec- essary to con fi rm the ef fi cacy of Sterify Gel and explore its potential use in managing periodontal disease. Additionally, future research should further investigate the optimal fre- quency and duration of Sterify Gel application. In conclusion, our study demonstrates the potential of Sterify Gel as an effective adjunct therapy for chronic peri- odontitis. By adhering to the gingival tissue and alveolar bone, Sterify Gel provides comprehensive coverage, support- ing the healing process and helping to prevent the recurrence of bacterial infections. Medical devices such as Sterify Gel may represent a viable alternative to antibiotic — and disinfectant- based treatments and address the unmet need for more effec- tive management strategies for periodontal disease. Further research is needed to con fi rm these fi ndings and explore the broader implications of using medical devices in managing periodontal disease and antimicrobial resistance. Data Availability Data are available upon request due to privacy restrictions. Additional Points Patents . Sterify S.r.l. holds patents for its innovative formula- tions: WO 2021/099981 A1, which covers the controlled- viscosity polymeric hydrogel and its preparation method, and WO 2021/099983 A1, which pertains to the lantibiotic solution against bacterial infections. Ethical Approval The study was conducted in accordance with the Declaration of Helsinki and approved by Comitato Etico dell ’ Insubria on 9 August 2022 and the Italian Ministry of Health on 2 December 2022. Consent Informed consent was obtained from all subjects involved in the study. Disclosure The investigators were completely independent in their research, unin fl uenced by the funding source, and their actions remained uncompromised by any fi nancial ties. Con fl icts of Interest The authors declare they have no con fl icts of interest.
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