2
International Journal of Dentistry
parameters and prevent the recurrence of in fl ammation and infection. In addition, Sterify Gel ’ s mechanism of action may reduce the use of antibiotics and the associated risk of anti- biotic resistance, allowing for the maintenance of patients who cannot undergo surgical treatment. 2. Materials and Methods 2.1. Selection Criteria. The study includes patients with Grades III and IV chronic periodontal disease according to the Euro- pean Federation of Periodontology classi fi cation involving at least two sites. Sites needed to be distant and in different quad- rants. Inclusion criteria include an age older than 18, a mini- mum of six teeth with a periodontal PD of more than 5 mm, and at least 20 teeth. Exclusion criteria include hypersensitivity to one or more components of the device, pregnancy or breast- feeding, heavy smoking, concomitant dental disease, diabetes mellitus, rheumatoid arthritis, aggressive periodontitis, history of radio — or chemotherapy, mucosal autoimmune disorders, mental illnesses, parafunctions, such as bruxism, use of anti- biotics in the last 3 months, and periodontal surgery in the previous 12 months in the study areas. The study population comprises 34 subjects for a total of 68 treated sites. 2.2. Study Design. The study was a prospective, randomized, controlled, and split-mouth investigation study designed to assess the safety and ef fi cacy of Sterify Gel (Sterify, Turin, Italy) as an adjunctive treatment following nonsurgical SRP for periodontitis in comparison with SRP alone. 2.3. Medical Device Features. Sterify Gel is a CE-certi fi ed (CE 0426) sterile ready-to-use hydrogel mainly composed of polyvinyl alcohol and polyvinylpyrrolidone (PVP) in citrate buffer solution, with the addition of three excipients, namely hydroxytyrosol (HT, visco-modulator), magnesium ascorbyl phosphate (MAP, gamma ray protector), and nisin (preservative). 2.4. Study Procedures. Following informed consent, each patient ’ s mouth was divided into segments to identify two or more sites to be treated. Simple randomization was used to assign one site the nonsurgical procedure only (control) and the other site the nonsurgical procedure associated with the use of Ster- ify Gel (treatment). This was executed using a virtual coin fl ip to ensure 50/50 probability of site assignment to each group. The nonsurgical procedure involved SRP under local anesthe- sia with EMS scalers and Gracey curettes (Hu-Friedy, Chicago, Illinois, United States). After the procedure, Sterify Gel was applied directly inside the periodontal pocket in the treatment group with the help of a 23G blunt tip needle. Volume of injection was up to 0.3 ml. Participants followed a standard oral hygiene program, which included twice-daily brushing with fl uoride toothpaste and daily use of dental fl oss or interdental brush, except on the day of treatment when patients were advised not to clean the interdental spaces. Data collection included periodontal PD, bleeding index, pla- que index, gingival level of recession, level of clinical attach- ment, degree of mobility, furcations, and pain, which were evaluated at baseline, 1, 2, and 3 months after treatment. Examiners in this study were not blinded to the treatment assignments of the sites. Detection and quanti fi cation of
break down supragingival bacterial bio fi lm and decontamina- tion of periodontal pockets through root surface debridement (RSD) and scaling and root planing (SRP) that remove subgin- gival plaque and tartar. The aim is to mechanically remove the causative factor of periodontitis and thus promote natural healing of the gingiva and reduction of periodontal pockets [5]. However, both the depth and anatomical complexity of the pocket sometimes limit such maneuvers, and based on this, new bacterial colonization can in fi ltrate and reinfect the pock- ets after RSD and SRP, inhibiting the healing process [6]. Adjunctive treatments combined with RSD and SRP have been developed to improve gingival healing and prevent recurrent infection and in fl ammation of periodontal pockets. Some of these methods include antimicrobial laser therapy through the activation of a photosensitive molecule (photo- dynamic therapy) [7], or the use of antibiotics or antimicro- bial molecules carried directly into periodontal pockets to reduce the bacterial load present and prevent reinfection. Release can be achieved by using paste or scaffolds, which are placed in pockets to allow for local and gradual distribu- tion of antimicrobials over a period of days or weeks [8]. In addition to local delivery, antibiotics can also be adminis- tered systemically [9]; however, there is a risk of causing antibiotic resistance, which, in addition to being a signi fi cant health risk to the world ’ s population [10, 11], can worsen the patient ’ s clinical picture by rendering standard antibiotic treatments ineffective [12]. Other treatments involve the reduction of pocket depth (PD) by resective or regenerative techniques through surgical approaches to restore the system to health. Although numer- ous clinical trials demonstrated the ef fi cacy of SRP, treat- ments in combination with this technique can dramatically improve clinical parameters and prevent recurrence [13, 14]. In the search for alternative treatments that do not rely on antibiotics, Sterify Gel has been developed as a potential solution. The design of this Class III medical device addresses the challenges associated with periodontal pockets, offering a new approach in the fi eld of periodontal care. Composed of polyvinyl polymers, hydroxytyrosol (HT), nisin, magnesium, ascorbyl phosphate (MAP), and citrate buffered saline, Sterify Gel presents unique properties that contribute to its potential ef fi cacy. With its viscoelastic and mucoadhesive characteris- tics, the gel can effectively penetrate even the most challenging and inaccessible areas within the periodontal and peri-implant pockets, similar to other gels ’ behavior [15, 16]. The inclusion of HT as an antioxidant [17, 18] and nisin as a preservative bacteriostatic agent [19] adds further stability to the gel for- mulation [20]. In the context of scienti fi c exploration, Sterify Gel represents a noteworthy avenue for investigation as a potential antibiotic-free adjunctive treatment for periodontal pockets. This randomized controlled trial aims to evaluate the safety and ef fi cacy of Sterify Gel as an adjunctive treatment to SRP in promoting healing of periodontal pockets. The study aims to compare the ef fi cacy of SRP alone with SRP combined with Sterify Gel, which may fi nd useful application in cases of moderate to advanced chronic periodontal dis- ease. The trial ’ s objective is to improve and accelerate healing
Made with FlippingBook Annual report