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Clinical Trial NCT07489924 for Periodontal Diseases, Diabetes Mellitus Type 2 is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Microbiological Effect of 0.12% Chlorhexidine Digluconate and 0.05% Cetylpyridinium Chloride vs Probiotics (Lactobacillus Reuteri Prodentis) on Porphyromonas Gingivalis. Phase 4 20 Randomized

Active, not recruiting
Clinical Trial NCT07489924 is designed to study Treatment for Periodontal Diseases, Diabetes Mellitus Type 2. It is a Phase 4 interventional study that is active, not recruiting, having started on 8 January 2023, with plans to enroll 20 participants. Led by Universidad de Colima, it is expected to complete by 31 July 2026. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
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. ...Show More
Official 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.

Conditions
Periodontal DiseasesDiabetes Mellitus Type 2
Other Study IDs
  • CEI 2024/1/CR/CL/ODON/182
NCT ID Number
NCT07489924
Start Date (Actual)
2023-01-08
Last Update Posted
2026-03-24
Completion Date (Estimated)
2026-07-31
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
Phase 4
Status
Active, not recruiting
Keywords
diabetes mellitus
Probiotics
Chlorhexidine digluconate
Cetylpyridinium chloride
qPCR
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorMouthwash 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.
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.
ExperimentalProbiotic (Lactobacillus reuteri Prodentis)
BioGaia® ProD (L. reuteri Prodentis); dosage: 1 buccodispersible tablet per day (2×10⁸), for 30 days. Prior: non-surgical periodontal therapy.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Porphyromonas gingivalis bacteria
Change in Porphyromonas gingivalis load in crevicular fluid (DNA copies by qPCR) from baseline to 30 days.
30 days
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Treatment adherence.
The ARMS-E test was applied to measure therapeutic adherence.
30 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
35 Years
Eligible Sexes
All

  • • 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.

  • 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.
Universidad de Colima logoUniversidad de Colima
Secretaria de Salud, Mexico logoSecretaria de Salud, Mexico
No contact data.
1 Study Locations in 1 Countries
University of Colima, Colima, 28040, Mexico