RecruitingPhase 4NCT06792916

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

Evaluation of Subgingival Mechanical Periodontal Therapy with the Additional Local Application of a Spermidine-Based Gel


Sponsor

Luca Ramaglia

Enrollment

12 participants

Start Date

Jan 25, 2025

Study Type

INTERVENTIONAL

Conditions

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. Secondary outcome include evaluating other periodontal parameters like bleeding on probing, FMBS and FMPS and CAL over a 12-month period.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

  • 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 Criteria2

  • 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.

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Interventions

PROCEDUREspermidine and minimally invasive non surgical tecnique

minimally non surgical periodontal therapy will be performed with the adjunct of spermidine based gel

OTHERperidontal therapy (minimally invasive non surgical tecnique)

subgingival instrumentation will be performed according to MINST


Locations(1)

AOU Federico II

Naples, Italy, Italy

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NCT06792916