Subgingival Lactobacillus Reuteri as an Adjunct to Non-Surgical Periodontal Therapy in Diabetic Patients
NCT07652255 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2026-06-17
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.
Conditions
- Periodontitis
- Diabetes Mellitus
Interventions
- DIETARY_SUPPLEMENT
-
Lactobacillus 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.
- OTHER
-
saline 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 & Collaborators
-
University of Medicine and Pharmacy at Ho Chi Minh City
lead OTHER
Principal Investigators
-
Thu Nguyen Ngoc Yen, PhD · Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-14
- Primary Completion
- 2026-04-15
- Completion
- 2026-04-30
Countries
- Vietnam
Study Locations
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