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Clinical Trials in Mexico / NCT07489924
Active, not recruiting Phase 4

Microbiological Effect of 0.12% Chlorhexidine Digluconate and 0.05% Cetylpyridinium Chloride vs Probiotics (Lactobacillus Reuteri Prodentis) on Porphyromonas Gingivalis.

NCT07489924 · tracked via the Priya Life Science Mexico tracker
Sponsor
Universidad de Colima
Phase
Phase 4
Started
2023-01-08
Last updated
2026-03-24

Condition(s) studied

Periodontal DiseasesDiabetes Mellitus Type 2

Investigational drug(s) / intervention(s)

Mouthwash with chlorhexidine and cetylpyridine chlorideProbiotic (Lactobacillus reuteri Prodentis

Mouthwash with chlorhexidine and cetylpyridine chloride: GUM® Paroex chlorhexidine 0.12% and cetylpyridinium chloride 0.05%; dosage: 10 mL orally, rinse for 60 seconds, twice daily for 30 days. Prior: non-surgical periodontal therapy.

Probiotic (Lactobacillus reuteri Prodentis: BioGaia® ProD (L. reuteri Prodentis); dosage: 1 buccodispersible tablet per day (2×10⁸), for 30 days. Prior: non-surgical periodontal therapy.

Study summary

This randomized non-inferiority clinical trial aims to evaluate the microbiological effect of 0.12% chlorhexidine and 0.05% cetylpyridinium vs. probiotics (Lactobacillus reuteri Prodentis) on Porphyromonas gingivalis in patients with periodontal disease and diabetes mellitus in Colima, where molecular biology tests such as qPCR will be performed at the end, before and after treatment in each of the groups.

Eligibility

Sex
ALL
Min age
35 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * • Previous diagnosis of controlled type 2 diabetes mellitus. * Periodontal disease (≥2 quadrants affected; probing depth ≥4 mm; bleeding on probing \>10%). * Patients affiliated with the Unidad de Salud Zona Oriente (IMSS-BIENESTAR). * Signed informed consent. Exclusion Criteria: * Inability to cooperate. * Antibiotic treatment within the last 3 months. * Soft tissue pathologies not related to periodontal disease. Elimination Criteria: * Failure to complete the study. * Insufficient or non-extracted DNA sample. * Indication of antibiotics/fluoxetine during the intervention.

Primary outcome measure(s)

  • Porphyromonas gingivalis bacteria — 30 days
    Change in Porphyromonas gingivalis load in crevicular fluid (DNA copies by qPCR) from baseline to 30 days.

Trial sites (1)

FacilityCityRegionStatus
University of Colima Colima Mexico

Other trials for the same condition

Glycemic Control and the Ask Me 3® Educational Program Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07489924 on ClinicalTrials.gov ↗ ← All trials in Mexico