PeriodontitisNCT07619040
Patient-Reported Probiotic Use During Periodontal Therapy in Periodontitis
An observational study of Periodontitis and Probiotic, run by Medipol University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontitis, Probiotic, Oral Hygiene, Oral Health
- What is being tested?
- non surgical periodontal therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2025to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage 3 grade b periodontitis who applied to the Periodontology Department of Istanbul Medipol University Faculty of Dentistry
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota School of Dentistry
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- non surgical periodontal therapy
- Keywords
- periodontitis, probiotics, non-surgical periodontal therapy, oral health-related quality of life
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non surgical periodontal therapyProcedure or surgery
Also called non surgical periodontal treatment
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.).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: non surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: before treatment, 1 month and 3 months after treatment
Secondary outcomes (3)
Percentage of Participants with Probiotic Familiarity
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.
Measured: before treatment, 1 month and 3 months after treatment
Percentage of Participants Reporting Positive Attitudes Toward Probiotics
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.
Measured: before treatment, 1 month and 3 months after treatment
Percentage of Participants Accepting Probiotic Use as an Adjunct to Periodontal Care
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.
Measured: before treatment, 1 month and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start20 Dec 2025
- Primary completion25 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Can, Medipol University
- Investigators
- Alpdogan Kantarci, Study chair, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619040
- Sponsor's protocol ID
- 1553; 11.12.2025
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24164569
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Probiotic Use During Non-Surgical Periodontal Therapy in Stage III Grade B Periodontitis: Clinical Findings, Oral Health Impact and Behavioral Correlates
- ClinicalTrials.gov ID
- NCT07619040
- Acronym / sponsor ID
- 1553; 11.12.2025
- Keywords
- periodontitis, probiotics, non-surgical periodontal therapy, oral health-related quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-reported probiotic product users with periodontitis | – | Procedure: non surgical periodontal therapyStage 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. |
| Non-users probiotic with periodontitis | – | Procedure: non surgical periodontal therapyStage 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage 3 grade b periodontitis who applied to the Periodontology Department of Istanbul Medipol University Faculty of Dentistry
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non surgical periodontal therapyAlso: non surgical periodontal treatmentAll 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.). | Procedure or surgery | Non-users probiotic with periodontitis, Self-reported probiotic product users with periodontitis |
Primary outcome
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.
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.
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.
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.
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.
3 secondary outcomes
Percentage of Participants with Probiotic Familiarity
Time frame: before treatment, 1 month and 3 months after treatment
Percentage of Participants Reporting Positive Attitudes Toward Probiotics
Time frame: before treatment, 1 month and 3 months after treatment
Percentage of Participants Accepting Probiotic Use as an Adjunct to Periodontal Care
Time frame: before treatment, 1 month and 3 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 24164569Teughels 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alpdogan Kantarci study chair
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Probiotic, run by Medipol University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Silness and Löe Plaque Index Score (time frame: before treatment, 1 month and 3 months after treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07619040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.