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临床试验/NCT07619040
NCT07619040已完成不适用

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

Medipol University1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2025年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
130
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.
  • Availability for baseline, 1-month, and 3-month clinical and questionnaire evaluations.

排除标准

  • 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.

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve Can

Asistant Prof Dr

Medipol University

研究点 (1)

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