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

ConditionPeriodontitis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorIRCCS San Raffaele

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged >18 years

Diagnosis of stage II, III, or IV periodontitis

Non-smokers

Negative medical history

Disqualifiers

Smokers

Pregnancy

Surgical re-treatment during the maintenance period

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
Baseline, 6 weeks, 12 weeks, and 24 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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