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Completed

NCT Number: NCT07619040

Patient-Reported Probiotic Use During Periodontal Therapy in Periodontitis

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota School of Dentistry

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non surgical periodontal therapy

Procedure

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.).

Other names: non surgical periodontal treatment

Primary outcomes

  1. Change from Baseline in Silness and Löe Plaque Index Score

    Time frame: 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.

  2. Change from Baseline in Percentage of Bleeding Sites

    Time frame: 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.

  3. Change from Baseline in Probing Pocket Depth in Millimeters

    Time frame: 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.

  4. Change from Baseline in Clinical Attachment Level in Millimeters

    Time frame: 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.

  5. Change from Baseline in 14-item Oral Health Impact Profile Total scores

    Time frame: 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.

Secondary outcomes

  1. Percentage of Participants with Probiotic Familiarity

    Time frame: 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.

  2. Percentage of Participants Reporting Positive Attitudes Toward Probiotics

    Time frame: 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.

  3. Percentage of Participants Accepting Probiotic Use as an Adjunct to Periodontal Care

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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