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

Phase 4

Recruiting

• Conditions: Peridontitis

• Registration Number: NCT06792916
• Lead Sponsor: Luca Ramaglia

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-20
• Study Start: 2025-01-25
• Study First Posted: 2025-01-27
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-06-20
• Study Completion: 2026-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Probing depth (PD)	From non surgical periodontal therapy to 6 months	peridontal probing depth

Trial Locations

Locations (1)

AOU Federico II; 🇮🇹 Naples, Italy