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| Name | Class |
|---|---|
| Secretaria de Salud, Mexico | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mouthwash with chlorhexidine and cetylpyridine chloride | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Porphyromonas gingivalis bacteria | Change in Porphyromonas gingivalis load in crevicular fluid (DNA copies by qPCR) from baseline to 30 days. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment adherence. | The ARMS-E test was applied to measure therapeutic adherence. | 30 days |
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Inclusion Criteria:
• Previous diagnosis of controlled type 2 diabetes mellitus.
Exclusion Criteria:
Inability to cooperate.
Elimination Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ROSA YOLITZY CARDENAS MARIA, Ph.D | Universidad de Colima | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colima | Colima | 28040 | Mexico |
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| Label | URL |
|---|---|
| Diseño y estandarización de la técnica de PCR para Porphyromonas gingivalis | View source |
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I have decided not to authorize the sharing of my individual data for privacy reasons."
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It is a randomized non-inferiority clinical trial
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| Probiotic (Lactobacillus reuteri Prodentis | Biological | BioGaia® ProD (L. reuteri Prodentis); dosage: 1 buccodispersible tablet per day (2×10⁸), for 30 days. Prior: non-surgical periodontal therapy. |
|
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D009067 | Mouthwashes |
| D002710 | Chlorhexidine |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003358 | Cosmetics |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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