Subgingival Lactobacillus Reuteri as an Adjunct to Non-Surgical Periodontal Therapy in Diabetic Patients

NCT07652255 | Completed

• 1 other identifier: THS-PERIO-2026-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Diabetes Mellitus

Keywords

Lactobacillus reuteri; Probiotics; Periodontitis; Diabetes Mellitus; Scaling and Root Planing; Non-surgical Periodontal Therapy; HbA1c; Periodontal Pathogens

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (3)

• Change in Clinical Attachment Level (CAL)

  Baseline to 3 months.

• Changes in Glycated Hemoglobin (HbA1c)

  Baseline, 1 month, and 3 months

• Changes in Subgingival Periodontal Pathogens

  Baseline to 3 months

Study Arms (2)

SRP + Lactobacillus reuteri

EXPERIMENTAL

Subgingival Lactobacillus reuteri

Dietary Supplement: Lactobacillus Reuteri Oral Solution [BioGaia]

SRP + Saline

ACTIVE COMPARATOR

Saline Control

Other: saline control

Interventions

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.

SRP + Lactobacillus reuteri

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.

SRP + Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Thu Nguyen Ngoc Yen, PhD

  Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, and outcome assessors were blinded to treatment allocation. The clinician administering the intervention was not involved in outcome assessment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student, Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start: November 14, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 30, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)