Sterify Gel as an Adjunct to Non-Surgical Periodontal Therapy in Periodontitis

NCT07672665 | Not Yet Recruiting

• 1 other identifier: Sterify
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This retrospective observational study will evaluate the clinical response to Sterify Gel, a sterile mucoadhesive polymeric hydrogel, when used as an adjunct to non-surgical periodontal therapy in adult patients with stage II, III, or IV periodontitis. The study will analyze already existing anonymized clinical records from patients treated at the Periodontal Unit of IRCCS Ospedale San Raffaele in Milan, Italy. Patients included in the analysis received scaling and root planing/minimally invasive non-surgical periodontal therapy, followed by local application of Sterify Gel into periodontal pockets with probing depth greater than 4 mm. The main objective is to assess reduction in periodontal pocket depth from baseline to 6, 12, and 24 weeks. Other periodontal clinical parameters, including clinical attachment level, gingival recession, bleeding, plaque score, tooth mobility, and furcation involvement, will also be evaluated.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Change in Probing Pocket Depth (PPD)

  Change in probing pocket depth from baseline to 6, 12, and 24 weeks in treated periodontal pockets with baseline PPD greater than 4 mm.

  Baseline, 6 weeks, 12 weeks, and 24 weeks

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with stage II, III, or IV periodontitis treated at the Periodontal Unit of the Dental Department, IRCCS Ospedale San Raffaele, Milan, Italy. Patients included in the study received non-surgical periodontal therapy with scaling and root planing/minimally invasive non-surgical therapy plus local application of a mucoadhesive polymeric hydrogel into periodontal pockets with probing depth greater than 4 mm. The analysis will be based on anonymized retrospective clinical records collected from January 1, 2024 to September 30, 2025.

You may qualify if:

• Adult patients aged \>18 years
• Diagnosis of stage II, III, or IV periodontitis
• Non-smokers
• Negative medical history
• Patients treated with scaling and root planing/minimally invasive non-surgical periodontal therapy plus mucoadhesive polymeric hydrogel
• Patients enrolled in supportive periodontal care

You may not qualify if:

• Smokers
• Pregnancy
• Surgical re-treatment during the maintenance period

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06