Subgingival Lactobacillus Reuteri as an Adjunct to Non-Surgical Periodontal Therapy in Diabetic Patients (LREUTERI-DM)

June 11, 2026 updated by: Vo Thi Hue Truc, University of Medicine and Pharmacy at Ho Chi Minh City

Effect of Adjunctive Subgingival Lactobacillus Reuteri in Non-Surgical Periodontal Therapy for Periodontitis in Patients With Diabetes: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Ho Chi Minh City
      • Ho Chi Minh City, Ho Chi Minh City, Vietnam, 700000
        • Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SRP + Lactobacillus reuteri
Subgingival Lactobacillus reuteri
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.
Active Comparator: SRP + Saline
Saline Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on Probing (BOP)
Time Frame: 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.
Baseline to 3 months
Change in Probing Pocket Depth (PPD)
Time Frame: 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.
Baseline to 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Attachment Level (CAL)
Time Frame: 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.
Baseline to 3 months.
Changes in Glycated Hemoglobin (HbA1c)
Time Frame: Baseline, 1 month, and 3 months
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
Time Frame: Baseline to 3 months
Quantitative levels of Porphyromonas gingivalis, Tannerella forsythia, Fusobacterium nucleatum were assessed using microbiological analysis.
Baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Investigators

  • Study Chair: Thu Nguyen Ngoc Yen, PhD, Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2025

Primary Completion (Actual)

April 15, 2026

Study Completion (Actual)

April 30, 2026

Study Registration Dates

First Submitted

June 11, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THS-PERIO-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made publicly available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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