Periodontal DiseasesPhase 4NCT07489924
Microbiological Effect of 0.12% Chlorhexidine Digluconate and 0.05% Cetylpyridinium Chloride vs Probiotics (Lactobacillus Reuteri Prodentis) on Porphyromonas Gingivalis.
A Phase 4 study testing Mouthwash with chlorhexidine and cetylpyridine chloride and Probiotic (Lactobacillus reuteri Prodentis in people with Periodontal Diseases and Diabetes Mellitus Type 2, run by Universidad de Colima at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Periodontal Diseases, Diabetes Mellitus Type 2
- What is being tested?
- Mouthwash with chlorhexidine and cetylpyridine chloride and Probiotic (Lactobacillus reuteri Prodentis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 8 Jan 2023to 31 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Periodontal Diseases, Diabetes Mellitus Type 2
- Being tested
- Mouthwash with chlorhexidine and cetylpyridine chloride, Probiotic (Lactobacillus reuteri Prodentis
- Keywords
- diabetes mellitus, Probiotics, Chlorhexidine digluconate, Cetylpyridinium chloride, qPCR
- Medical subject headings
- Periodontal Diseases, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Probiotic (Lactobacillus reuteri Prodentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Porphyromonas gingivalis bacteria
Change in Porphyromonas gingivalis load in crevicular fluid (DNA copies by qPCR) from baseline to 30 days.
Measured: 30 days
Secondary outcomes (1)
Treatment adherence.
The ARMS-E test was applied to measure therapeutic adherence.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start8 Jan 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a randomized non-inferiority clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Colima
- Sponsor type
- University, hospital or other
- Collaborators
- Secretaria de Salud, Mexico
- Responsible party
- Sponsor
- Investigators
- ROSA YOLITZY CARDENAS MARIA, Ph.D, Study director, Universidad de Colima
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489924
- Sponsor's protocol ID
- CEI 2024/1/CR/CL/ODON/182
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I have decided not to authorize the sharing of my individual data for privacy reasons."
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07489924
- Acronym / sponsor ID
- CEI 2024/1/CR/CL/ODON/182
- Conditions
- Periodontal Diseases, Diabetes Mellitus Type 2
- Keywords
- diabetes mellitus, Probiotics, Chlorhexidine digluconate, Cetylpyridinium chloride, qPCR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad de ColimaUniversity, hospital or other
- Collaborators
- Secretaria de Salud, Mexico
- Study start
- 8 Jan 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- It is a randomized non-inferiority clinical trial
| Arm | Type | Receives |
|---|---|---|
| Mouthwash with chlorhexidine and cetylpyridine chloride | Active comparator | Drug: Mouthwash with chlorhexidine and cetylpyridine chlorideGUM® 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. |
| Probiotic (Lactobacillus reuteri Prodentis) | Experimental | Biological: Probiotic (Lactobacillus reuteri ProdentisBioGaia® ProD (L. reuteri Prodentis); dosage: 1 buccodispersible tablet per day (2×10⁸), for 30 days. Prior: non-surgical periodontal therapy. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Previous diagnosis of controlled type 2 diabetes mellitus.
Key exclusion criteria (7 listed)
- Inability to cooperate.
- Failure to complete the study.
- Insufficient or non-extracted DNA sample.
- Indication of antibiotics/fluoxetine during the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mouthwash with chlorhexidine and cetylpyridine chlorideGUM® 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 ProdentisBioGaia® 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) |
Primary outcome
Porphyromonas gingivalis bacteria
Time frame: 30 days
Change in Porphyromonas gingivalis load in crevicular fluid (DNA copies by qPCR) from baseline to 30 days.
1 secondary outcome
Treatment adherence.
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Diseño y estandarización de la técnica de PCR para Porphyromonas gingivalisLink provided by the sponsor.
- Rol de los Probióticos como bacterioterapia en Odontología. Revisión de la literaturaLink provided by the sponsor.
- Individual participant dataSharing planned: No. I have decided not to authorize the sharing of my individual data for privacy reasons."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ROSA YOLITZY CARDENAS MARIA, Ph.D study director
Universidad de Colima
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mouthwash with chlorhexidine and cetylpyridine chloride and Probiotic (Lactobacillus reuteri Prodentis in people with Periodontal Diseases and Diabetes Mellitus Type 2, run by Universidad de Colima at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Porphyromonas gingivalis bacteria (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.