Patient-Reported Probiotic Use During Periodontal Therapy in Periodontitis
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Minnesota
-
Minneapolis, Minnesota, 미국, 55455
- University of Minnesota School of Dentistry
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
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.).
다른 이름들:
|
|
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.
|
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.).
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from Baseline in Silness and Löe Plaque Index Score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants with Probiotic Familiarity
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 연구 의자: Alpdogan Kantarci, University of Minnesota
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .