Patient-Reported Probiotic Use During Periodontal Therapy in Periodontitis

NCT07619040 | Completed DMC

• 1 other identifier: 1553; 11.12.2025
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis; Probiotic; Oral Hygiene, Oral Health; Periodontal Therapy

Keywords

periodontitis; probiotics; non-surgical periodontal therapy; oral health-related quality of life

Outcome Measures

Primary Outcomes (5)

• Change from Baseline in Silness and Löe Plaque Index Score

  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

  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

  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

  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

  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

Secondary Outcomes (3)

• Percentage of Participants with Probiotic Familiarity

  before treatment, 1 month and 3 months after treatment

• Percentage of Participants Reporting Positive Attitudes Toward Probiotics

  before treatment, 1 month and 3 months after treatment

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

  before treatment, 1 month and 3 months after treatment

Study Arms (2)

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.

Procedure: non surgical periodontal therapy

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.

Procedure: non surgical periodontal therapy

Interventions

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.).

Also known as: non surgical periodontal treatment

Non-users probiotic with periodontitis; Self-reported probiotic product users with periodontitis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

University of Minnesota School of Dentistry

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Teughels W, Durukan A, Ozcelik O, Pauwels M, Quirynen M, Haytac MC. Clinical and microbiological effects of Lactobacillus reuteri probiotics in the treatment of chronic periodontitis: a randomized placebo-controlled study. J Clin Periodontol. 2013 Nov;40(11):1025-35. doi: 10.1111/jcpe.12155. Epub 2013 Sep 15.

  PMID: 24164569 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Alpdogan Kantarci

  University of Minnesota

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Prof Dr

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 1, 2026
• Study Start: December 20, 2025
• Primary Completion: April 25, 2026
• Study Completion: April 30, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

US (1)