This Study Evaluates the Clinical Effect of Adding Spermidine Gel to Minimally Invasive Non-surgical Periodontal Therapy (MINST) to Improve Periodontal Health.

February 25, 2025 updated by: Luca Ramaglia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Naples, Italy, 80013
        • Recruiting
        • AOU Federico II

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

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MINST plus spermidine gel
Procedure: spermidine and minimally invasive non surgical tecnique
minimally non surgical periodontal therapy will be performed with the adjunct of spermidine based gel
Active Comparator: MINST (minimally invasive non surgical tecnique)
Other: peridontal therapy (minimally invasive non surgical tecnique)
subgingival instrumentation will be performed according to MINST

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth (PD)
Time Frame: From non surgical periodontal therapy to 6 months
peridontal probing depth
From non surgical periodontal therapy to 6 months

Collaborators and Investigators

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

Sponsor

Luca Ramaglia

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 (Actual)

January 25, 2025

Primary Completion (Estimated)

June 20, 2025

Study Completion (Estimated)

January 20, 2026

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 342/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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