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Patient-Reported Probiotic Use During Periodontal Therapy in Periodontitis

27 maggio 2026 aggiornato da: Merve Can, Medipol University

Patient-Reported Probiotic Use During Non-Surgical Periodontal Therapy in Stage III Grade B Periodontitis: Clinical Findings, Oral Health Impact and Behavioral Correlates

Most previous studies have evaluated standardized probiotic regimens as adjuncts to NSPT (Ausenda et al., 2023; Hardan et al., 2022; Mauriello et al., 2025). Less is known about how real-world probiotic product use during periodontal care relates simultaneously to clinical outcomes, OHRQoL and patient-level behavioral factors such as knowledge, acceptance, previous recommendation and product/form preferences. Therefore, the aim of this prospective observational study was to compare periodontal clinical and OHRQoL outcomes at 1 and 3 months after NSPT between patients with Stage III Grade B periodontitis who reported probiotic supplement or commercially labelled probiotic product use and those who reported no such use. A secondary aim was to evaluate whether pre-treatment probiotic knowledge/familiarity, attitudes, previous probiotic recommendation, acceptance profile and product/form preferences were associated with reported probiotic product use.

This study hypothesized that reported probiotic product use during the NSPT period would be associated with lower short-term periodontal burden and better OHRQoL outcomes, and that pre-treatment probiotic familiarity and acceptance would be associated with reported use.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study included 130 stage 3 grade b periodontitis patients, classified as self-reported probiotic product users or non-users (n = 65 each). Periodontitis was defined by detectable interdental CAL at two or more non-adjacent teeth. Stage III Grade B periodontitis was defined by interdental CAL ≥5 mm at the site of greatest loss, with grading based on a bone loss/age ratio of 0.25-1.00.

All patients received routine non surgical periodontal therapy, including individualized oral hygiene instruction and supra- and subgingival mechanical debridement/root surface instrumentation where indicated.

The study did not include an investigator-assigned probiotic intervention. No probiotic strain, dose, formulation, frequency, duration or adherence protocol was prescribed as part of the study. Group classification was based on self-reported use of probiotic supplements or commercially labelled probiotic products during active periodontal treatment and post-treatment follow-up. Patients who reported such use were classified as probiotic product users, whereas those reporting no probiotic supplement or commercially labelled probiotic product use during the same interval were classified as non-users. Traditional homemade fermented foods, including homemade yogurt, kefir, pickles, vinegar, sourdough products and boza, were recorded as dietary fermented-food habits when reported but were not used to define probiotic exposure because strain composition, colony-forming unit content, microbial viability, dose and consistency of intake could not be verified (FAO/WHO, 2002; Hill et al., 2014; Sahin, 2026). Therefore, the exposure represented self-reported real-world probiotic-labelled product use rather than standardized probiotic intake.

Plaque index (PI), probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), sites with PPD ≥5 mm and the 14-item Oral Health Impact Profile (OHIP-14) were recorded at baseline, 1 month and 3 months. Probiotic-related knowledge,attitudes and acceptance were assessed using questionnaires.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

130

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55455
        • University of Minnesota School of Dentistry

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients with stage 3 grade b periodontitis who applied to the Periodontology Department of Istanbul Medipol University Faculty of Dentistry

Descrizione

Inclusion Criteria:

Adults aged 18-70 years. Presence of at least 20 natural teeth. Diagnosis of Stage III Grade B periodontitis. Periodontitis defined as detectable interdental clinical attachment loss at two or more non-adjacent teeth.

Stage III periodontitis defined as interdental clinical attachment loss ≥5 mm at the site of greatest loss.

Grade B periodontitis defined by a bone loss/age ratio of 0.25-1.00. Availability for baseline, 1-month, and 3-month clinical and questionnaire evaluations.

Exclusion Criteria:

Use of systemic antibiotics within the previous 3 months. Periodontal treatment within the previous 6 months. Presence of systemic disease. Pregnancy or lactation. Severe cognitive or psychiatric conditions that could interfere with questionnaire completion or follow-up.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Self-reported probiotic product users with periodontitis
Stage 3 Grabe B Periodontitis patients who reported such use were classified as probiotic product users. All patients received routine non-surgical periodontal therapy, including individualized oral hygiene instruction and supra- and subgingival mechanical debridement/root surface instrumentation where indicated. Eligible participants were 18-70 years of age, had at least 20 natural teeth, were diagnosed with Stage III Grade B periodontitis and were available for baseline, 1-month and 3-month evaluations. Patients were excluded if they had used systemic antibiotics within the previous 3 months, had received periodontal treatment within the previous 6 months, had systemic disease, were pregnant or lactating, or had severe cognitive or psychiatric conditions that could interfere with questionnaire completion or follow-up.
Procedura: non surgical periodontal therapy
All patients received routine NSPT, including individualized oral hygiene instruction and supra- and subgingival mechanical debridement/root surface instrumentation where indicated (Herrera et al., 2020; Suvan et al., 2020). All NSPT procedures were performed by the same periodontist (M.C.).
Altri nomi:
  • non surgical periodontal treatment
Non-users probiotic with periodontitis
Stage 3 Grabe B Periodontitis patients who those reporting no probiotic supplement or commercially labelled probiotic product use during the same interval were classified as non-users. All patients received routine non-surgical periodontal therapy, including individualized oral hygiene instruction and supra- and subgingival mechanical debridement/root surface instrumentation where indicated. Eligible participants were 18-70 years of age, had at least 20 natural teeth, were diagnosed with Stage III Grade B periodontitis and were available for baseline, 1-month and 3-month evaluations. Patients were excluded if they had used systemic antibiotics within the previous 3 months, had received periodontal treatment within the previous 6 months, had systemic disease, were pregnant or lactating, or had severe cognitive or psychiatric conditions that could interfere with questionnaire completion or follow-up.
Procedura: non surgical periodontal therapy
All patients received routine NSPT, including individualized oral hygiene instruction and supra- and subgingival mechanical debridement/root surface instrumentation where indicated (Herrera et al., 2020; Suvan et al., 2020). All NSPT procedures were performed by the same periodontist (M.C.).
Altri nomi:
  • non surgical periodontal treatment

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Silness and Löe Plaque Index Score
Lasso di tempo: before treatment, 1 month and 3 months after treatment
Plaque accumulation will be assessed using the Silness and Löe Plaque Index during clinical periodontal examination with a Williams periodontal probe. Plaque will be scored from 0 to 3 at the gingival margin, with higher scores indicating greater plaque accumulation. The outcome will be expressed as the mean plaque index score per patient.
before treatment, 1 month and 3 months after treatment
Change from Baseline in Percentage of Bleeding Sites
Lasso di tempo: before treatment, 1 month and 3 months after treatment
Bleeding on probing will be assessed using a Williams periodontal probe and recorded dichotomously as present (+) or absent (-) at each periodontal site within 10 seconds after gentle probing. The outcome will be expressed as the percentage of bleeding sites per patient.
before treatment, 1 month and 3 months after treatment
Change from Baseline in Probing Pocket Depth in Millimeters
Lasso di tempo: before treatment, 1 month and 3 months after treatment
Probing pocket depth will be measured in millimeters (mm) using a Williams periodontal probe as the distance from the gingival margin to the base of the periodontal pocket. The outcome will be expressed as the mean probing pocket depth per patient.
before treatment, 1 month and 3 months after treatment
Change from Baseline in Clinical Attachment Level in Millimeters
Lasso di tempo: before treatment, 1 month and 3 months after treatment
Clinical attachment level will be measured in millimeters (mm) using a Williams periodontal probe as the distance from the cemento-enamel junction to the base of the periodontal pocket. The outcome will be expressed as the mean clinical attachment level per patient.
before treatment, 1 month and 3 months after treatment
Change from Baseline in 14-item Oral Health Impact Profile Total scores
Lasso di tempo: before treatment, 1 month and 3 months after treatment
Oral health-related quality of life will be assessed using the 14-item Oral Health Impact Profile questionnaire. Each item will be scored on a 1-to-5 Likert scale, and the total OHIP-14 score will be calculated by summing all item scores. The outcome will be expressed as a total score ranging from 14 to 70, with higher scores indicating poorer oral health-related quality of life.
before treatment, 1 month and 3 months after treatment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants with Probiotic Familiarity
Lasso di tempo: before treatment, 1 month and 3 months after treatment
Probiotic familiarity will be assessed using an investigator-developed structured questionnaire evaluating whether participants have previously heard of probiotics or are familiar with probiotic products. The outcome will be expressed as the percentage of participants giving affirmative responses to probiotic familiarity items.
before treatment, 1 month and 3 months after treatment
Percentage of Participants Reporting Positive Attitudes Toward Probiotics
Lasso di tempo: before treatment, 1 month and 3 months after treatment
Probiotic-related attitudes will be assessed using an investigator-developed structured questionnaire evaluating participants' perceptions of the potential benefits of probiotics for oral and periodontal health. The outcome will be expressed as the percentage of participants giving affirmative responses to positive attitude items.
before treatment, 1 month and 3 months after treatment
Percentage of Participants Accepting Probiotic Use as an Adjunct to Periodontal Care
Lasso di tempo: before treatment, 1 month and 3 months after treatment
Probiotic acceptance will be assessed using an investigator-developed structured questionnaire evaluating participants' willingness to use probiotic products as an adjunct to periodontal treatment. The outcome will be expressed as the percentage of participants reporting acceptance or willingness to use probiotics during periodontal care.
before treatment, 1 month and 3 months after treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Medipol University

Investigatori

  • Cattedra di studio: Alpdogan Kantarci, University of Minnesota

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 dicembre 2025

Completamento primario (Effettivo)

25 aprile 2026

Completamento dello studio (Effettivo)

30 aprile 2026

Date di iscrizione allo studio

Primo inviato

20 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 maggio 2026

Primo Inserito (Effettivo)

1 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1553; 11.12.2025

Piano per i dati dei singoli partecipanti (IPD)

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INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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