NCT07489924

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Universidad de Colima · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Periodontal Diseases
• Diabetes Mellitus Type 2

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-01-08
• Primary completion: 2025-07-31
• Completion: 2026-07-31
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

1 site across 1 country: Mexico