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

L

Luca Ramaglia

Status and phase

Enrolling
Phase 4

Conditions

Peridontitis

Treatments

Other: peridontal therapy (minimally invasive non surgical tecnique)
Procedure: spermidine and minimally invasive non surgical tecnique

Study type

Interventional

Funder types

Other

Identifiers

NCT06792916
342/2024

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

12 participants in 2 patient groups

MINST plus spermidine gel
Experimental group
Treatment:
Procedure: spermidine and minimally invasive non surgical tecnique
MINST (minimally invasive non surgical tecnique)
Active Comparator group
Treatment:
Other: peridontal therapy (minimally invasive non surgical tecnique)

Trial contacts and locations

1

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Central trial contact

Luca Ramaglia, Professor

Data sourced from clinicaltrials.gov

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