Subgingival Lactobacillus Reuteri as an Adjunct to Non-Surgical Periodontal Therapy in Diabetic Patients (LREUTERI-DM)
Effect of Adjunctive Subgingival Lactobacillus Reuteri in Non-Surgical Periodontal Therapy for Periodontitis in Patients With Diabetes: A Randomized Controlled Clinical Trial
Studieoversikt
Status
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Ho Chi Minh City
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Ho Chi Minh City, Ho Chi Minh City, Vietnam, 700000
- Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: SRP + Lactobacillus reuteri
Subgingival Lactobacillus reuteri
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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.
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Aktiv komparator: SRP + Saline
Saline Control
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Bleeding on Probing (BOP)
Tidsramme: Baseline to 3 months
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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.
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Baseline to 3 months
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Change in Probing Pocket Depth (PPD)
Tidsramme: Baseline to 3 months.
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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.
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Baseline to 3 months.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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Baseline to 3 months.
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Changes in Glycated Hemoglobin (HbA1c)
Tidsramme: Baseline, 1 month, and 3 months
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HbA1c levels were assessed at baseline, 1 month, and 3 months following treatment to evaluate glycemic control.
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Baseline, 1 month, and 3 months
|
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Changes in Subgingival Periodontal Pathogens
Tidsramme: Baseline to 3 months
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Quantitative levels of Porphyromonas gingivalis, Tannerella forsythia, Fusobacterium nucleatum were assessed using microbiological analysis.
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Baseline to 3 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Thu Nguyen Ngoc Yen, PhD, Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- THS-PERIO-2026-01
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