Clinical effects of a novel approach in step 2 of periodontal therapy for severe periodontitis: mechanical subgingival instrumentation with the adjunctive use of a mucoadhesive hydrogel. A pilot randomized controlled study
Severe periodontitis (stage III–IV, 2018 classification of periodontal and peri-implant diseases and conditions)
Both arms receive EFP step 1 (oral hygiene instruction, professional mechanical plaque removal, risk-factor control), followed under local anaesthesia by full-mouth subgingival instrumentation in step 2 using ultrasonic (EMS Piezon Master with PerioSlim inserts) and hand instrumentation (Gracey curettes), to a smooth root surface. Test arm: in addition, Sterify Gel is applied with a 23G blunt-tip needle into all periodontal pockets ≥4 mm, from the base of the pocket to the gingival margin, immediately after instrumentation. Control arm: the identical protocol without Sterify Gel. All treatments are performed by a single experienced periodontology specialist. Participants are allocated 1:1 by a computer-generated random sequence (random.org). Clinical parameters are recorded by a blinded calibrated examiner at baseline, 1 month and 3 months. Sterify Gel is a Class III sterile, single-use mucoadhesive polymeric hydrogel (poly[vinyl alcohol]–poly[vinylpyrrolidone] with hydroxytyrosol, nisin, and magnesium ascorbyl phosphate in citrate-buffered saline); manufacturer Sterify S.r.l., Torino, Italy.
1. Systemically healthy adults aged ≥18 years 2. Periodontitis stage III or IV (2018 classification) 3. CAL >5 mm and PD >6 mm with supra-/infra-alveolar defects at the required minimum number of sites 4. Sufficient natural teeth present (wisdom teeth excluded) 5. No periodontal treatment in the preceding defined period 6. Written informed consent
1. Systemic disease affecting the periodontium (e.g. uncontrolled diabetes); medications affecting healing (chronic corticosteroids, IV bisphosphonates) 2. Hypersensitivity to any component of the product 3. Pregnant or lactating women 4. Antibiotics or anti-inflammatory medication within the preceding 3 months 5. Smoking [fix threshold — all current smokers, or >10 cigarettes/day] 6. Enrolment in another clinical trial; psychiatric disorders / non-compliance