PeriodontitisSterifyNCT07672665
Sterify Gel as an Adjunct to Non-Surgical Periodontal Therapy in Periodontitis
An observational study of Periodontitis, run by IRCCS San Raffaele.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Periodontitis
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Smokers
- Pregnancy
- Surgical re-treatment during the maintenance period
About this study
Official title: 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.
- Conditions
- Periodontitis
- Medical subject headings
- Periodontitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, 12 weeks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rotundo Roberto, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672665
- Sponsor's protocol ID
- Sterify
- Acronym
- Sterify
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adjunctive Effect of a Mucoadhesive Polymeric Hydrogel to Non-surgical Periodontal Therapy: a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT07672665
- Acronym / sponsor ID
- Sterify / Sterify
- Conditions
- Periodontitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Smokers
- Pregnancy
- Surgical re-treatment during the maintenance period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by IRCCS San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Probing Pocket Depth (PPD) (time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.