A Phase 4 interventional study of Mouthwash with chlorhexidine and cetylpyridine chloride and Probiotic (Lactobacillus reuteri Prodentis in Periodontal Diseases and Diabetes Mellitus Type 2, sponsored by Universidad de Colima. Active, not recruiting at 1 site in Mexico. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Universidad de Colima · Phase 4, Interventional, and Treatment
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.
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.
867 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.
This study's enrollment of 20 is below the median of 45 across 557 interventional studies indexed under Periodontal Diseases.
Browse Periodontal Diseases studies →Universidad de Colima is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Previous diagnosis of controlled type 2 diabetes mellitus.
Exclusion Criteria:
Inability to cooperate.
Elimination Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Porphyromonas gingivalis bacteria
Change in Porphyromonas gingivalis load in crevicular fluid (DNA copies by qPCR) from baseline to 30 days.
Time frame: 30 days
Treatment adherence.
The ARMS-E test was applied to measure therapeutic adherence.
Time frame: 30 days
Plan to share: No — I have decided not to authorize the sharing of my individual data for privacy reasons."
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Probiotic
Universidad de Colima