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

March 18, 2026 updated by: Universidad de Colima

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Colima, Mexico, 28040
        • University of Colima

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: 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.
Experimental: 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.
Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Porphyromonas gingivalis bacteria
Time Frame: 30 days
Change in Porphyromonas gingivalis load in crevicular fluid (DNA copies by qPCR) from baseline to 30 days.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment adherence.
Time Frame: 30 days
The ARMS-E test was applied to measure therapeutic adherence.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Colima

Collaborators

Secretaria de Salud, Mexico

Investigators

  • Study Director: ROSA YOLITZY CARDENAS MARIA, Ph.D, Universidad de Colima

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2023

Primary Completion (Actual)

July 31, 2025

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI 2024/1/CR/CL/ODON/182

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I have decided not to authorize the sharing of my individual data for privacy reasons."

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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