PeriodontitisLREUTERI-DMNCT07652255
Subgingival Lactobacillus Reuteri as an Adjunct to Non-Surgical Periodontal Therapy in Diabetic Patients
A study testing Lactobacillus Reuteri Oral Solution [BioGaia] in people with Periodontitis and Diabetes Mellitus, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Diabetes Mellitus
- What is being tested?
- Lactobacillus Reuteri Oral Solution [BioGaia]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteVietnam
- Study dates
- 14 Nov 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh City, 700000
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontitis, Diabetes Mellitus
- Being tested
- Lactobacillus Reuteri Oral Solution [BioGaia], saline control
- Keywords
- Lactobacillus reuteri, Probiotics, Periodontitis, Diabetes Mellitus, Scaling and Root Planing, Non-surgical Periodontal Therapy, HbA1c, Periodontal Pathogens
- Medical subject headings
- Periodontitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
saline controlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SRP + Lactobacillus reuteri | Experimental | Subgingival Lactobacillus reuteri Receives: Dietary Supplement: Lactobacillus Reuteri Oral Solution [BioGaia] |
| SRP + Saline | Active comparator | Saline Control Receives: Other: saline control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 3 months.
Secondary outcomes (3)
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.
Measured: Baseline to 3 months.
Changes in Glycated Hemoglobin (HbA1c)
HbA1c levels were assessed at baseline, 1 month, and 3 months following treatment to evaluate glycemic control.
Measured: 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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start14 Nov 2025
- Primary completion15 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vo Thi Hue Truc, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Thu Nguyen Ngoc Yen, PhD, Study chair, Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652255
- Sponsor's protocol ID
- THS-PERIO-2026-01
- Acronym
- LREUTERI-DM
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adjunctive Subgingival Lactobacillus Reuteri in Non-Surgical Periodontal Therapy for Periodontitis in Patients With Diabetes: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07652255
- Acronym / sponsor ID
- LREUTERI-DM / THS-PERIO-2026-01
- Conditions
- Periodontitis, Diabetes Mellitus
- Keywords
- Lactobacillus reuteri, Probiotics, Periodontitis, Diabetes Mellitus, Scaling and Root Planing, Non-surgical Periodontal Therapy, HbA1c, Periodontal Pathogens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SRP + Lactobacillus reuteri | Experimental | Dietary Supplement: Lactobacillus Reuteri Oral Solution [BioGaia]Subgingival Lactobacillus reuteri |
| SRP + Saline | Active comparator | Other: saline controlSaline Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | SRP + Lactobacillus reuteri |
| saline controlSubgingival 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. | Other | SRP + Saline |
Primary outcome
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.
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.
3 secondary outcomes
Change in Clinical Attachment Level (CAL)
Time frame: Baseline to 3 months.
Changes in Glycated Hemoglobin (HbA1c)
Time frame: Baseline, 1 month, and 3 months
Changes in Subgingival Periodontal Pathogens
Time frame: Baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thu Nguyen Ngoc Yen, PhD study chair
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus Reuteri Oral Solution [BioGaia] in people with Periodontitis and Diabetes Mellitus, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on Probing (BOP) (time frame: Baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.