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NCT Number: NCT07489924

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colima

Colima, 28040, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mouthwash with chlorhexidine and cetylpyridine chloride

Drug

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

Biological

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

Primary outcomes

  1. Porphyromonas gingivalis bacteria

    Time frame: 30 days

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

Secondary outcomes

  1. Treatment adherence.

    Time frame: 30 days

    The ARMS-E test was applied to measure therapeutic adherence.

Sponsors and collaborators

Lead sponsor

Universidad de Colima

Other

Collaborators

  • Secretaria de Salud, Mexico

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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