Diabetes Mellitus, Periodontitis
Conditions
Keywords
Lactobacillus reuteri, Probiotics, Periodontitis, Diabetes Mellitus, Scaling and Root Planing, Non-surgical Periodontal Therapy, HbA1c, Periodontal Pathogens
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus Reuteri Oral Solution [BioGaia]
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.
OTHERsaline control
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.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants, investigators, and outcome assessors were blinded to treatment allocation. The clinician administering the intervention was not involved in outcome assessment.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years. * Diagnosed with diabetes mellitus according to WHO criteria. * Stage III Grade B periodontitis or higher according to the 2017 AAP/EFP classification. * At least 15 remaining teeth. * Periodontal pockets ≥5 mm with bleeding on probing. * Clinical attachment loss ≥5 mm.
Exclusion criteria
* Current smokers. * Pregnant or lactating women. * Use of antibiotics or anti-inflammatory medications within 1 month before enrollment. * Periodontal therapy within the previous 3 months. * Undergoing orthodontic treatment. * Presence of pulpal lesions or severe occlusal trauma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on Probing (BOP) | Baseline to 3 months | 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. |
| Change in Probing Pocket Depth (PPD) | Baseline to 3 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Attachment Level (CAL) | Baseline to 3 months. | Clinical attachment level (CAL) was measured using a UNC-15 periodontal probe. Changes in CAL was assessed to evaluate periodontal attachment gain following treatment. |
| Changes in Glycated Hemoglobin (HbA1c) | Baseline, 1 month, and 3 months | HbA1c levels were assessed at baseline, 1 month, and 3 months following treatment to evaluate glycemic control. |
| Changes in Subgingival Periodontal Pathogens | Baseline to 3 months | Quantitative levels of Porphyromonas gingivalis, Tannerella forsythia, Fusobacterium nucleatum were assessed using microbiological analysis. |
Countries
Vietnam
Contacts
STUDY_CHAIRThu Nguyen Ngoc Yen, PhD
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Outcome results
None listed