PeridontitisPhase 4NCT06792916
This Study Evaluates the Clinical Effect of Adding Spermidine Gel to Minimally Invasive Non-surgical Periodontal Therapy (MINST) to Improve Periodontal Health.
A Phase 4 study testing spermidine and minimally invasive non surgical tecnique and peridontal therapy (minimally invasive non surgical tecnique) in people with Peridontitis, run by Luca Ramaglia at 1 site in Italy.
Trial summary
This study investigates the effectiveness of using a spermidine-based gel as an adjunct to minimally invasive non-surgical periodontal therapy (MINST) for treating periodontitis. The primary outcome is to assess whether the addition of spermidine gel reduces pocket depth (PPD) compared to MINST alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peridontitis
- What is being tested?
- spermidine and minimally invasive non surgical tecnique and peridontal therapy (minimally invasive non surgical tecnique)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jan 2025to 20 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older. Presence of untreated periodontitis with at least 2 sites showing clinical attachment loss (CAL) > 2 mm and probing depth (PD) > 4 mm.
- Voluntary signing of informed consent.
Who cannot join
- Presence of systemic diseases (e.g., diabetes mellitus, cardiovascular, renal, hepatic, or pulmonary conditions).
- Smokers (≥10 cigarettes per day). Pregnancy or breastfeeding. Allergy to any ingredients in the products used in the study. Diseases affecting bone and/or connective tissue metabolism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Subgingival Mechanical Periodontal Therapy With the Additional Local Application of a Spermidine-Based Gel
This study investigates the effectiveness of using a spermidine-based gel as an adjunct to minimally invasive non-surgical periodontal therapy (MINST) for treating periodontitis. The primary outcome is to assess whether the addition of spermidine gel reduces pocket depth (PPD) compared to MINST alone. Secondary outcome include evaluating other periodontal parameters like bleeding on probing, FMBS and FMPS and CAL over a 12-month period.
- Conditions
- Peridontitis
- Being tested
- spermidine and minimally invasive non surgical tecnique, peridontal therapy (minimally invasive non surgical tecnique)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spermidine and minimally invasive non surgical tecniqueProcedure or surgery
minimally non surgical periodontal therapy will be performed with the adjunct of spermidine based gel
peridontal therapy (minimally invasive non surgical tecnique)Other
subgingival instrumentation will be performed according to MINST
| Study group | Role | What they receive |
|---|---|---|
| MINST plus spermidine gel | Experimental | Not described |
| MINST (minimally invasive non surgical tecnique) | Active comparator | Not described Receives: Other: peridontal therapy (minimally invasive non surgical tecnique) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in probing depth (PD)
variations in periodontal probing depth between baseline and follow-up
Measured: From non surgical periodontal therapy to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start25 Jan 2025
- Primary completion20 Jun 2025
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeridontitisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luca Ramaglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luca Ramaglia, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792916
- Sponsor's protocol ID
- 342/2024
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Subgingival Mechanical Periodontal Therapy With the Additional Local Application of a Spermidine-Based Gel
- ClinicalTrials.gov ID
- NCT06792916
- Acronym / sponsor ID
- 342/2024
- Conditions
- Peridontitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Luca RamagliaUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 27 Jan 2025 (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 study investigates the effectiveness of using a spermidine-based gel as an adjunct to minimally invasive non-surgical periodontal therapy (MINST) for treating periodontitis. The primary outcome is to assess whether the addition of spermidine gel reduces pocket depth (PPD) compared to MINST alone. Secondary outcome include evaluating other periodontal parameters like bleeding on probing, FMBS and FMPS and CAL over a 12-month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINST plus spermidine gel | Experimental | – |
| MINST (minimally invasive non surgical tecnique) | Active comparator | Other: peridontal therapy (minimally invasive non surgical tecnique) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older. Presence of untreated periodontitis with at least 2 sites showing clinical attachment loss (CAL) > 2 mm and probing depth (PD) > 4 mm.
- Voluntary signing of informed consent.
Key exclusion criteria (2 listed)
- Presence of systemic diseases (e.g., diabetes mellitus, cardiovascular, renal, hepatic, or pulmonary conditions).
- Smokers (≥10 cigarettes per day). Pregnancy or breastfeeding. Allergy to any ingredients in the products used in the study. Diseases affecting bone and/or connective tissue metabolism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spermidine and minimally invasive non surgical tecniqueminimally non surgical periodontal therapy will be performed with the adjunct of spermidine based gel | Procedure or surgery | – |
| peridontal therapy (minimally invasive non surgical tecnique)subgingival instrumentation will be performed according to MINST | Other | MINST (minimally invasive non surgical tecnique) |
Primary outcome
Changes in probing depth (PD)
Time frame: From non surgical periodontal therapy to 6 months
variations in periodontal probing depth between baseline and follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing spermidine and minimally invasive non surgical tecnique and peridontal therapy (minimally invasive non surgical tecnique) in people with Peridontitis, run by Luca Ramaglia at 1 site in Italy.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in probing depth (PD) (time frame: From non surgical periodontal therapy to 6 months). 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 15 Jul 2026.