Diabetes Mellitus Type 2, Periodontal Diseases
Conditions
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
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.
BioGaia® ProD (L. reuteri Prodentis); dosage: 1 buccodispersible tablet per day (2×10⁸), for 30 days. Prior: non-surgical periodontal therapy.
Sponsors
Study design
Intervention model description
It is a randomized non-inferiority clinical trial
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Porphyromonas gingivalis bacteria | 30 days | Change in Porphyromonas gingivalis load in crevicular fluid (DNA copies by qPCR) from baseline to 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment adherence. | 30 days | The ARMS-E test was applied to measure therapeutic adherence. |
Countries
Mexico
Contacts
Universidad de Colima