A mucoadhesive gel (Sterify Gel) used alongside deep cleaning to treat severe gum disease (periodontitis): a pilot study

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN97961964

Enrollment

Registered

2026-06-11

Start date

2025-10-01

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe periodontitis (stage III–IV, 2018 classification of periodontal and peri-implant diseases and conditions) Oral Health

Interventions

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

manufacturer Sterify S.r.l., Torino, Italy.

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Countries

Romania

Contacts

Public ContactHoria Calniceanu

calniceanu.horia@umft.ro+40745322649

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 29, 2026