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

Microbiological Effect of 0.12% Chlorhexidine Digluconate and 0.05% Cetylpyridinium Chloride vs. Probiotic (Lactobacillus Reuteri Prodentis) of Porphyromonas Gingivalis in Patients With Periodontal Disease and Type 2 Diabetes Mellitus in Colima. a Randomized Non-inferiority Clinical Trial.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07489924
Enrollment
20
Registered
2026-03-24
Start date
2023-01-08
Completion date
2026-07-31
Last updated
2026-03-24

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

Conditions

Diabetes Mellitus Type 2, Periodontal Diseases

Keywords

diabetes mellitus, Probiotics, Chlorhexidine digluconate, Cetylpyridinium chloride, qPCR

Brief 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.

Detailed description

Our study will be divided into two groups: in group 1, we will provide a mouthwash containing 0.12% chlorhexidine and 0.05% cetylpyridinium as treatment, and in group 2, patients will be administered oral probiotic capsules (Lactobacillus reuteri Prodentis). A periodontogram will be performed for both groups to determine the area of the mouth with the highest bacterial presence due to the deepest periodontal pocket. From there, a crevicular fluid sample will be taken from which the red complex bacteria causing periodontal disease will be obtained, using sterile #30 endodontic paper points. Before the start of treatments, both groups will receive the mechanical Gold Standard treatment for periodontal disease, which is non-surgical periodontal therapy (dental prophylaxis). Both therapeutic agents will be administered for 4 weeks, after which a sample will be taken from the same periodontal pocket as the first one, and the microbiological effect of 0.12% chlorhexidine and 0.05% cetylpyridinium vs. probiotics (Lactobacillus reuteri Prodentis) will be evaluated. Patients will then have a rest period of 3 months, after which the treatments will be crossed, following the same previous procedure.

Interventions

DRUGMouthwash 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.

BIOLOGICALProbiotic (Lactobacillus reuteri Prodentis

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

Sponsors

Universidad de Colima
Lead SponsorOTHER
Secretaria de Salud, Mexico
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Intervention model description

It is a randomized non-inferiority clinical trial

Eligibility

Sex/Gender
ALL
Age
35 Years to 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.

Design outcomes

Primary

MeasureTime frameDescription
Porphyromonas gingivalis bacteria30 daysChange in Porphyromonas gingivalis load in crevicular fluid (DNA copies by qPCR) from baseline to 30 days.

Secondary

MeasureTime frameDescription
Treatment adherence.30 daysThe ARMS-E test was applied to measure therapeutic adherence.

Countries

Mexico

Contacts

STUDY_DIRECTORROSA YOLITZY CARDENAS MARIA, Ph.D

Universidad de Colima

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026