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

11. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

5

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: SRP + Lactobacillus reuteri
Subgingival Lactobacillus reuteri
Kosttilskudd: 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.
Aktiv komparator: SRP + Saline
Saline Control
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Bleeding on Probing (BOP)
Tidsramme: 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)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Clinical Attachment Level (CAL)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline to 3 months
Quantitative levels of Porphyromonas gingivalis, Tannerella forsythia, Fusobacterium nucleatum were assessed using microbiological analysis.
Baseline to 3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. november 2025

Primær fullføring (Faktiske)

15. april 2026

Studiet fullført (Faktiske)

30. april 2026

Datoer for studieregistrering

Først innsendt

11. juni 2026

Først innsendt som oppfylte QC-kriteriene

11. juni 2026

Først lagt ut (Faktiske)

17. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • THS-PERIO-2026-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be made publicly available

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Sukkersyke

Kliniske studier på Lactobacillus Reuteri Oral Solution [BioGaia]

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