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This randomized controlled clinical trial evaluates the adjunctive effect of subgingival administration of Lactobacillus reuteri probiotics in diabetic patients with Stage III Grade B or higher periodontitis receiving non-surgical periodontal therapy. Forty periodontal sites were randomly assigned to either a test group treated with scaling and root planing (SRP) plus subgingival Lactobacillus reuteri or a control group treated with SRP plus saline irrigation. Clinical periodontal parameters, microbiological outcomes, and glycated hemoglobin (HbA1c) levels were assessed at baseline, 1 month, and 3 months. The study aims to determine whether locally delivered probiotics provide additional clinical, microbiological, and glycemic benefits compared with SRP plus saline irrigation.
Periodontitis is a chronic inflammatory disease associated with dysbiotic subgingival biofilms and is strongly influenced by diabetes mellitus. Chronic hyperglycemia may impair immune function and wound healing, resulting in increased periodontal destruction and poorer treatment outcomes. Non-surgical periodontal therapy based on scaling and root planing (SRP) remains the standard treatment; however, residual periodontal pockets may persist after therapy.
Lactobacillus reuteri probiotics have demonstrated antimicrobial, anti-inflammatory, and host-modulatory properties and may enhance periodontal healing. This randomized controlled clinical trial evaluated the adjunctive effects of subgingival administration of a liquid probiotic preparation containing Lactobacillus reuteri in diabetic patients with Stage III Grade B or higher periodontitis.
Forty periodontal sites were randomly allocated to either a test group receiving SRP plus subgingival Lactobacillus reuteri probiotics or a control group receiving SRP plus saline irrigation. A second application was performed at the 1-month visit. Clinical outcomes included plaque index, gingival index, bleeding on probing, probing pocket depth, and clinical attachment level. Glycemic control was evaluated using HbA1c levels, and microbiological analysis was performed using real-time PCR for Porphyromonas gingivalis, Tannerella forsythia, and Fusobacterium nucleatum.
Assessments were conducted at baseline, 1 month, and 3 months. The primary objective was to evaluate changes in clinical outcomes. Secondary objectives included microbiological and glycemic outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRP + Lactobacillus reuteri | Experimental | Subgingival Lactobacillus reuteri |
|
| SRP + Saline | Active Comparator | Saline Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus Reuteri Oral Solution [BioGaia] | Dietary Supplement | Subgingival administration of liquid Lactobacillus reuteri following scaling and root planing. The probiotic solution was applied into periodontal pockets at baseline and re-applied after 1 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on Probing (BOP) | Bleeding on probing was assessed at baseline, 1 month, and 3 months after treatment. Changes in the percentage of bleeding sites were used to evaluate periodontal inflammation. | Baseline to 3 months |
| Change in Probing Pocket Depth (PPD) | Probing pocket depth was measured using a UNC-15 periodontal probe at baseline, 1 month, and 3 months after treatment. The primary outcome was the change in PPD from baseline to 3 months. | Baseline to 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Attachment Level (CAL) | Clinical attachment level (CAL) was measured using a UNC-15 periodontal probe. Changes in CAL was assessed to evaluate periodontal attachment gain following treatment. | Baseline to 3 months. |
| Changes in Glycated Hemoglobin (HbA1c) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thu Nguyen Ngoc Yen, PhD | Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City | Ho Chi Minh City | Ho Chi Minh City | 700000 | Vietnam |
Individual participant data will not be made publicly available
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In this randomized split-mouth clinical trial, each participant received subgingival Lactobacillus reuteri at one periodontal site and saline at a contralateral control site following scaling and root planing. Participants were followed for 3 months.
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Participants, investigators, and outcome assessors were blinded to treatment allocation. The clinician administering the intervention was not involved in outcome assessment.
| saline control | Other | Subgingival administration of sterile saline solution following scaling and root planing. Saline was applied into periodontal pockets at baseline and re-applied after 1 month using the same protocol as the test intervention. |
|
HbA1c levels were assessed at baseline, 1 month, and 3 months following treatment to evaluate glycemic control. |
| Baseline, 1 month, and 3 months |
| Changes in Subgingival Periodontal Pathogens | Quantitative levels of Porphyromonas gingivalis, Tannerella forsythia, Fusobacterium nucleatum were assessed using microbiological analysis. | Baseline to 3 months |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| 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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