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

June 22, 2026 updated by: Rotundo Roberto, IRCCS San Raffaele

The Adjunctive Effect of a Mucoadhesive Polymeric Hydrogel to Non-surgical Periodontal Therapy: a Retrospective Analysis

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Probing Pocket Depth (PPD)
Time Frame: Baseline, 6 weeks, 12 weeks, and 24 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sterify

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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