NCT07489924

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2023

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

March 18, 2026

Last Update Submit

March 18, 2026

Conditions

Periodontal DiseasesDiabetes Mellitus Type 2

Keywords

diabetes mellitusProbioticsChlorhexidine digluconateCetylpyridinium chlorideqPCR

Outcome Measures

Primary Outcomes (1)

  • Porphyromonas gingivalis bacteria

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

    30 days

Secondary Outcomes (1)

  • Treatment adherence.

    30 days

Study Arms (2)

Mouthwash with chlorhexidine and cetylpyridine chloride

ACTIVE COMPARATOR

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.

Drug: Mouthwash with chlorhexidine and cetylpyridine chloride

Probiotic (Lactobacillus reuteri Prodentis)

EXPERIMENTAL

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

Biological: Probiotic (Lactobacillus reuteri Prodentis

Interventions

Mouthwash with chlorhexidine and cetylpyridine chlorideDRUG

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
Probiotic (Lactobacillus reuteri ProdentisBIOLOGICAL

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)

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colima

Colima, 28040, Mexico

Location

Related Links

MeSH Terms

Conditions

Periodontal DiseasesDiabetes Mellitus, Type 2Diabetes Mellitus

Interventions

MouthwashesChlorhexidineProbiotics

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesCosmeticsManufactured MaterialsTechnology, Industry, and AgricultureBiguanidesGuanidinesAmidinesOrganic ChemicalsDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • ROSA YOLITZY CARDENAS MARIA, Ph.D

    Universidad de Colima

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It is a randomized non-inferiority clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

January 8, 2023

Primary Completion

July 31, 2025

Study Completion

July 31, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

I have decided not to authorize the sharing of my individual data for privacy reasons."

Locations

ME(1)