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

Universidad de Colima

Status and phase: Active, not recruiting; Phase 4

Conditions: Diabetes Mellitus Type 2; Periodontal Diseases

Treatments: Drug: Mouthwash with chlorhexidine and cetylpyridine chloride; Biological: Probiotic (Lactobacillus reuteri Prodentis

Study type: Interventional

Funder types: Other

Identifiers

NCT07489924

CEI 2024/1/CR/CL/ODON/182

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

Mouthwash with chlorhexidine and cetylpyridine chloride

Active Comparator group

Description:

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.

Treatment:

Drug: Mouthwash with chlorhexidine and cetylpyridine chloride

Probiotic (Lactobacillus reuteri Prodentis)

Experimental group

Description:

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

Treatment:

Biological: Probiotic (Lactobacillus reuteri Prodentis