Peri-implant MucositisNCT05926557
Treatment of Peri-implant Mucositis by Application of a Spermidine-based Gel
A study testing Spermidine gel and NSMD in people with Peri-implant Mucositis and Mucositis Oral, run by Federico II University at 1 site in Italy.
Trial summary
The aim of the study is to evaluate the potential of a spermidine-based topical gel as an adjuvant to non-surgical treatment of peri-implant mucositis. After a meticulous selection, patients will be randomly assigned to Test (spermidine gel + non-surgical debridement) or Control group (non-surgical debridement). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis, Mucositis Oral
- What is being tested?
- Spermidine gel and NSMD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 1 Jun 2024
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Non-smokers and smokers ( ≤ 10 cigarettes/day);
- Presence of at least 1 implant in mucositis, clinically and radiographically detected;
- The implant in mucositis (tissue-level or bone-level) must support a fixed prosthetic device (single crown), cemented or screwed.
Who cannot join
- Cancer patients;
- Periodontally Compromised Patients;
- Uncontrolled diabetic patients;
- Prolonged antibiotic treatment or anti-inflammatory treatment in the previous 6 months;
- Pregnant or breastfeeding patients;
- Implants that support mobile prosthetic products;
- Implants in peri-implantitis, detected clinically and radiographically.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Peri-implant Mucositis by Non-surgical Debridement and Additional Application of a Spermidine-based Gel
The aim of the study is to evaluate the potential of a spermidine-based topical gel as an adjuvant to non-surgical treatment of peri-implant mucositis. After a meticulous selection, patients will be randomly assigned to Test (spermidine gel + non-surgical debridement) or Control group (non-surgical debridement).
Read the detailed description
Following the recording of the clinical parameters (BoP, FMPS, FMBS, PD), mechanical therapy (NSMD) will be performed in the Test group (spermidine gel) by means of an ultrasonic scaler with a plastic tip. Finally, the spermidine-based gel will be applied in the peri-implant sulcus using a blunt-tipped needle. Control group will instead be treated only through the NSMD.
Finally, after 3 months the clinical parameters (BoP, FMPS, FMBS, PD) will be recorded again and the final evaluation will be performed. Data analysis will be performed using statistical software.
- Conditions
- Peri-implant Mucositis, Mucositis Oral
- Being tested
- Spermidine gel, NSMD
- Keywords
- Peri-implant Mucositis, Spermidine
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spermidine gelProcedure or surgery
First step: Non-surgical mechanical debridement (NSMD) Second step: application of spermidine gel
NSMDProcedure or surgery
Only mechanical debridement with curettes and scaler peek tips
| Study group | Role | What they receive |
|---|---|---|
| Spermidine Group | Experimental | Mechanical therapy (NSMD) will be performed by means of an ultrasonic scaler with a plastic tip. Finally, the spermidine-based gel will be applied in the peri-implant sulcus using a blunt-tipped needle. Receives: Procedure: Spermidine gel |
| NSMD Group | Active comparator | Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler peek tips. Receives: Procedure: NSMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of BoP (+/-)
Bleeding on periodontal probing
Measured: baseline, 1 and 3 months after periodontal therapy
Secondary outcomes (3)
Change of Full-mouth Plaque Score (FMPS; %)
Percentage of all sites exhibiting plaque
Measured: baseline, 1 and 3 months after periodontal therapy
Change of Full-mouth Bleeding Score (FMBS; %)
Percentage of all sites exhibiting bleeding
Measured: baseline, 1 and 3 months after periodontal therapy
Change of Probing Depth (PD; millimeters)
Distance from the gingival margin to the bottom of the peri-implant pocket
Measured: baseline, 1 and 3 months after periodontal therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jul 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peri-implant MucositisStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be designed as a double-arm randomized controlled clinical trial. Mucositis will be treated with spermidine gel + non-surgical debridement (NSMD) in Test group and with NSMD alone in Control group. All clinical parameters will be recorded at baseline, 1 and 3 months.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Ramaglia, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926557
- Sponsor's protocol ID
- 249/2023
- Status last verified
- Feb 2024
- First submitted
- 22 Jun 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iorio-Siciliano V, Marasca D, Mauriello L, Vaia E, Stratul SI, Ramaglia L. Treatment of peri-implant mucositis using spermidine and calcium chloride as local adjunctive delivery to non-surgical mechanical debridement: a double-blind randomized controlled clinical trial. Clin Oral Investig. 2024 Sep 21;28(10):537. doi: 10.1007/s00784-024-05924-8.
PubMed 39304548
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Peri-implant Mucositis by Non-surgical Debridement and Additional Application of a Spermidine-based Gel
- ClinicalTrials.gov ID
- NCT05926557
- Acronym / sponsor ID
- 249/2023
- Conditions
- Peri-implant Mucositis, Mucositis Oral
- Keywords
- Peri-implant Mucositis, Spermidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 3 Jul 2023 (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.
The aim of the study is to evaluate the potential of a spermidine-based topical gel as an adjuvant to non-surgical treatment of peri-implant mucositis. After a meticulous selection, patients will be randomly assigned to Test (spermidine gel + non-surgical debridement) or Control group (non-surgical debridement).
Detailed description
Following the recording of the clinical parameters (BoP, FMPS, FMBS, PD), mechanical therapy (NSMD) will be performed in the Test group (spermidine gel) by means of an ultrasonic scaler with a plastic tip. Finally, the spermidine-based gel will be applied in the peri-implant sulcus using a blunt-tipped needle. Control group will instead be treated only through the NSMD.
Finally, after 3 months the clinical parameters (BoP, FMPS, FMBS, PD) will be recorded again and the final evaluation will be performed. Data analysis will be performed using statistical software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be designed as a double-arm randomized controlled clinical trial. Mucositis will be treated with spermidine gel + non-surgical debridement (NSMD) in Test group and with NSMD alone in Control group. All clinical parameters will be recorded at baseline, 1 and 3 months.
| Arm | Type | Receives |
|---|---|---|
| Spermidine Group | Experimental | Procedure: Spermidine gelMechanical therapy (NSMD) will be performed by means of an ultrasonic scaler with a plastic tip. Finally, the spermidine-based gel will be applied in the peri-implant sulcus using a blunt-tipped needle. |
| NSMD Group | Active comparator | Procedure: NSMDControl group will be treated only through a non-surgical mechanical therapy with curettes or scaler peek tips. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Non-smokers and smokers ( ≤ 10 cigarettes/day);
- Presence of at least 1 implant in mucositis, clinically and radiographically detected;
- The implant in mucositis (tissue-level or bone-level) must support a fixed prosthetic device (single crown), cemented or screwed.
Key exclusion criteria (7 listed)
- Cancer patients;
- Periodontally Compromised Patients;
- Uncontrolled diabetic patients;
- Prolonged antibiotic treatment or anti-inflammatory treatment in the previous 6 months;
- Pregnant or breastfeeding patients;
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 gelFirst step: Non-surgical mechanical debridement (NSMD) Second step: application of spermidine gel | Procedure or surgery | Spermidine Group |
| NSMDOnly mechanical debridement with curettes and scaler peek tips | Procedure or surgery | NSMD Group |
Primary outcome
Change of BoP (+/-)
Time frame: baseline, 1 and 3 months after periodontal therapy
Bleeding on periodontal probing
3 secondary outcomes
Change of Full-mouth Plaque Score (FMPS; %)
Time frame: baseline, 1 and 3 months after periodontal therapy
Change of Full-mouth Bleeding Score (FMBS; %)
Time frame: baseline, 1 and 3 months after periodontal therapy
Change of Probing Depth (PD; millimeters)
Time frame: baseline, 1 and 3 months after periodontal therapy
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 2 Sep 2026.
- Derived from this study: PubMed 39304548Iorio-Siciliano V, Marasca D, Mauriello L, Vaia E, Stratul SI, Ramaglia L. Treatment of peri-implant mucositis using spermidine and calcium chloride as local adjunctive delivery to non-surgical mechanical debridement: a double-blind randomized controlled clinical trial. Clin Oral Investig. 2024 Sep 21;28(10):537. doi: 10.1007/s00784-024-05924-8.
- Individual participant dataSharing planned: No
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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 study testing Spermidine gel and NSMD in people with Peri-implant Mucositis and Mucositis Oral, run by Federico II University 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 4 inclusion and 7 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 2 Sep 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.
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?
Change of BoP (+/-) (time frame: baseline, 1 and 3 months after periodontal therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05926557, which also lists 1 linked publication.
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 2 Sep 2026.