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Clinical, Microbiological and Immunological Effects of the Adjuvant Use of Systemic Antibiotics and Probiotics in the Non-surgical Treatment of Periodontitis

13. maj 2026 opdateret af: Ademir Leite Filho, University of Sao Paulo

Clinical, Microbiological and Immunological Effects of the Adjuvant Use of Systemic Antibiotics and Probiotics in the Non-surgical Treatment of Periodontitis: a Controlled and Randomized Clinical Trial

Although robust evidence supports the benefits of antibiotics in periodontal treatment, the potential adverse effects of this therapy cannot be overlooked. These include concerns regarding the emergence of antimicrobial resistance and the non-ecological impact of antimicrobials on the gut microbiome, which may be closely linked to the etiopathogenesis of periodontitis and to the maintenance of long-term periodontal treatment outcomes. In this context, probiotics may represent a promising alternative strategy to reduce the need for antibiotics, particularly in severe cases of periodontitis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Scaling and root planing (SRP) is the most widely used treatment modality in periodontal therapy. However, a subset of periodontal sites does not respond adequately to this approach, and certain individuals exhibit susceptibility patterns that limit their response to initial treatment. Therefore, to overcome the limitations of SRP alone, adjunctive therapies-such as antibiotics and probiotics-may be employed.

The aim of this randomized, controlled, double-blind clinical trial is to evaluate the effects of adjunctive therapies (antibiotics and probiotics) associated with non-surgical periodontal therapy in individuals diagnosed with periodontitis stages III or IV, grades B or C. A total of sixty individuals with a clinical diagnosis of periodontitis will be treated with SRP alone or SRP combined with antibiotics or probiotics. Participants will be randomly allocated into three groups: Control (SRP), Test 1 (SRP + amoxicillin and metronidazole), and Test 2 (SRP + probiotics).

The adjunctive agents evaluated in this study will be a combination of systemic antibiotics (amoxicillin and metronidazole) and the probiotic Bifidobacterium animalis subsp. lactis HN019. Antibiotics will be administered for 14 days, three times daily, whereas probiotics will be administered for 90 days, twice daily. Adjunctive therapies will commence immediately after the first week of periodontal instrumentation.

Clinical follow-up will be conducted at baseline (pre-intervention), and at 3, 6, 9, and 12 months post-treatment. At baseline, 6 months, and 12 months, gingival crevicular fluid, subgingival biofilm, peripheral blood, and fecal samples will be collected, along with the assessment of periodontal clinical parameters. Levels of the cytokines IL-6, TNF-α, IFN-γ, IL-10, IL-1β, and IL-8 will be quantified in gingival crevicular fluid and peripheral blood samples using enzyme-linked immunosorbent assays.

Subgingival biofilm and fecal samples will be subjected to 16S ribosomal RNA gene amplification by PCR and sequenced using Illumina technology (MiSeq or MiniSeq; Illumina, San Diego, CA, USA). Sequencing data will be analyzed using reference databases of the human oral and intestinal microbiomes. Statistical analyses will be performed using an alpha level of 0.05 (p < 0.05).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
    • São Paulo
      • Ribeirão Preto, São Paulo, Brasilien, 14040-904
        • Universidade de São Paulo

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Adults with a diagnosis of generalized periodontitis, defined as involvement of ≥30% of teeth, classified as: Stage III or Stage IV, and Grade B or Grade C, according to the 2018 classification.
  • Presence of at least one tooth with ≥1 interproximal site exhibiting: Probing depth (PD) ≥6 mm, and Clinical attachment loss (CAL) ≥5 mm.
  • Presence of at least 15 teeth, excluding third molars and teeth indicated for extraction.
  • Presence of at least 6 non contiguous teeth, each with ≥1 interproximal site presenting PD and CAL ≥5 mm.

Exclusion Criteria:

  • Current smokers or former smokers who quit less than 5 years prior to enrollment.
  • Pregnant or breastfeeding women.
  • History of periodontal treatment within the previous 6 months.
  • Continuous use of oral antiseptics within the last 6 months.
  • Use of systemic antibiotics, corticosteroids, non steroidal anti inflammatory drugs, immunosuppressants, estrogen, estrogen receptor modulators, or medications affecting bone metabolism (e.g., alendronate, calcitonin) within the last 6 months.
  • Presence of systemic conditions that may alter the host response, including: Diabetes mellitus, HIV infection, Down syndrome.
  • Medical conditions requiring antibiotic prophylaxis for dental procedures (e.g., mitral valve prolapse).
  • Known allergy or hypersensitivity to amoxicillin, metronidazole, penicillins, or related compounds.
  • Use of probiotics within the last 6 months.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Placebo
Eksperimentel: Probiotic
To compare the effects of probiotic as an adjuvant therapy
Andet: Probiotic Therapy
Patients will receive probiotic lozenges as an adjuvant therapy to periodontal treatment.
Eksperimentel: Antibiotic
To compare the effects as an adjuvant therapy
Medicin: Amoxicilin and Metronidazole
The antibiotic group will receive amoxicilin and metronidazole, the probiotic group will receive probiotics
Andre navne:
  • Amoxicilin, Metronidazole, Antibiotics

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Periodontal Probing Depth (PD)
Tidsramme: every 3 months, up to 1 year
A full-mouth periodontal examination will be performed using a North Carolina periodontal probe (Hu-Friedy, Chicago, IL, USA). Probing depth (PD) will be measured in millimeters at six sites per tooth.
every 3 months, up to 1 year
Clinical Attachment Level (CAL)
Tidsramme: Every 3 months, up to 1 year
Clinical attachment level (CAL) will be measured in millimeters at six sites per tooth using a North Carolina periodontal probe.
Every 3 months, up to 1 year
Bleeding on Probing (BOP)
Tidsramme: Every 3 months, up to 1 year
Bleeding on probing will be assessed dichotomously (presence/absence) at six sites per tooth during full-mouth periodontal examination
Every 3 months, up to 1 year
Visible Supragingival Biofilm
Tidsramme: Every 3 months, up to 1 year
Presence or absence of visible supragingival biofilm will be assessed on four tooth surfaces during full-mouth periodontal examination.
Every 3 months, up to 1 year
Distance from Cementoenamel Junction to Gingival Margin
Tidsramme: Every 3 months, up to 1 year
The distance from the cementoenamel junction to the gingival margin will be measured in millimeters at six sites per tooth.
Every 3 months, up to 1 year
Suppuration
Tidsramme: Every 3 months, up to 1 year
Suppuration will be assessed dichotomously (presence/absence) at six sites per tooth during periodontal examination.
Every 3 months, up to 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Sao Paulo

Efterforskere

  • Studieleder: Michel Reis Messora, PhD, University of Sao Paulo

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. august 2023

Primær færdiggørelse (Faktiske)

30. januar 2026

Studieafslutning (Faktiske)

11. februar 2026

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

13. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 75898223.7.0000.5419

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The study protocol will be shared as a guide for further research.

IPD-delingstidsramme

After the publication of the study

IPD-delingsadgangskriterier

Open access

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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