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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06792916

Enrollment

Registered

2025-01-27

Start date

2025-01-25

Completion date

2026-01-20

Last updated

2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peridontitis

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Changes in probing depth (PD)	From non surgical periodontal therapy to 6 months	variations in periodontal probing depth between baseline and follow-up

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026