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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. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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).

Studietype

Intervensjonell

Registrering (Faktiske)

60

Fase

  • Tidlig fase 1

Kontakter og plasseringer

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

Studiesteder

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

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

Tar imot friske 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

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: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Placebo
Eksperimentell: Probiotic
To compare the effects of probiotic as an adjuvant therapy
Annen: Probiotic Therapy
Patients will receive probiotic lozenges as an adjuvant therapy to periodontal treatment.
Eksperimentell: Antibiotic
To compare the effects as an adjuvant therapy
Legemiddel: Amoxicilin and Metronidazole
The antibiotic group will receive amoxicilin and metronidazole, the probiotic group will receive probiotics
Andre navn:
  • Amoxicilin, Metronidazole, Antibiotics

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

University of Sao Paulo

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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)

22. august 2023

Primær fullføring (Faktiske)

30. januar 2026

Studiet fullført (Faktiske)

11. februar 2026

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

13. mai 2026

Først lagt ut (Faktiske)

18. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 75898223.7.0000.5419

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

After the publication of the study

Tilgangskriterier for IPD-deling

Open access

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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