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OpenTrials
Completed

NCT Number: NCT06792916

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

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.

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Key information

Conditions

Peridontitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AOU Federico II

Naples, Italy, 80013

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

spermidine and minimally invasive non surgical tecnique

Procedure

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Luca Ramaglia

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 27, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.