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

NCT ID: NCT06792916

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-25

Study Completion Date

2026-01-20

Brief Summary

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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

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Conditions

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Peridontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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MINST plus spermidine gel

Group Type EXPERIMENTAL

spermidine and minimally invasive non surgical tecnique

Intervention Type PROCEDURE

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

MINST (minimally invasive non surgical tecnique)

Group Type ACTIVE_COMPARATOR

peridontal therapy (minimally invasive non surgical tecnique)

Intervention Type OTHER

subgingival instrumentation will be performed according to MINST

Interventions

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spermidine and minimally invasive non surgical tecnique

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

Intervention Type PROCEDURE

peridontal therapy (minimally invasive non surgical tecnique)

subgingival instrumentation will be performed according to MINST

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luca Ramaglia

OTHER

Sponsor Role lead

Responsible Party

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Luca Ramaglia

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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AOU Federico II

Naples, Italy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Luca Ramaglia, Professor

Role: CONTACT

081-7462496

Other Identifiers

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342/2024

Identifier Type: -

Identifier Source: org_study_id

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