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临床试验/NCT06715176
NCT06715176已完成不适用

Prognostic Utility of TREM-1 Pathway in Predicting Treatment Outcomes in Patients With Grades B and C Periodontitis

Aydin Adnan Menderes University1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2016年12月19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
123
试验地点
1
主要终点
Salivary TREM-1 level

研究概览

简要总结

This study investigated modulations in salivary triggering receptor expressed on myeloid cells (TREM)-1, peptidoglycan recognition protein 1 (PGLYRP1) and interleukin (IL)-1β levels between healthy, gingivitis and periodontitis patients, and in response to non-surgical periodontal treatment. Systemically healthy, non-smokers with gingivitis (n=31), stage III periodontitis (grade B: n=34, grade C: n=24) and periodontally-healthy controls (n=34) were recruited. Periodontitis patients (n=45) underwent non-surgical periodontal treatment. Saliva was collected at baseline (T0, all groups), and three times (T1, T3 and T6) post-treatment (periodontitis groups only). Salivary biomarkers and total protein were measured using commercial assays.

详细描述

Study population and design: For this study, systemically healthy, non-smokers with gingivitis (n = 31), stage III, grade B periodontitis (n = 34), stage III, grade C periodontitis (n = 24), and periodontally healthy controls (n = 34) were recruited at the Department of Periodontology, School of Dentistry, Aydın Adnan Menderes University, Aydın, Turkey.

Clinical examination and saliva collection: All participants were clinically examined at baseline (T0) and whole mouth plaque (PI) and gingival index (GI), probing depth (PD), bleeding on probing (BOP) and clinical attachment loss (CAL) were measured. Prior to clinical examinations, unstimulated whole saliva was collected from all participants at baseline (T0). Additionally, saliva sampling and clinical examinations were performed for all periodontitis patients (grade B and C) one (T1), three (T3) and six (T6) months after non-surgical periodontal treatment.

Non-surgical periodontal treatment protocol: The patients underwent non-surgical periodontal therapy including quadrant-based scaling and root planning (SRP) using ultrasonic instruments and periodontal curettes until the root surfaces were visibly and tactically clean and smooth. All participants were given routine oral hygiene instructions and asked to abstain from any anti-inflammatory drugs, antibiotics, or mouthwashes containing chlorhexidine throughout the study period. At every visit, oral hygiene instructions were reinforced, and the sites that did not respond to treatment at T1 underwent additional re-instrumentation at T3 and T6. While non-surgical treatment efficacy is often reported in terms of mean values of PD reduction and CAL gain, these metrics may not fully capture treatment success or periodontal stability.

Triggering receptor expressed on myeloid cells (TREM)-1, peptidoglycan recognition protein 1 (PGLYRP1) and interleukin (IL)-1β immunoassays and total protein determination: 249 saliva samples were included for the analysis of TREM-1, PGLYRP1 and IL-1β. Levels of those cytokines in saliva were measured by commercial enzyme-linked immunosorbent assays according to manufacturer's instructions. Total protein levels in saliva were measured by the BCA Protein Assay according to the manufacturer's guidelines.

Statistical analysis

Group comparisons were performed with Mann-Whitney, Kruskal-Wallis with Dunn-Bonferroni post-hoc, or Chi-square tests, whenever appropriate. Group comparisons before and after treatment were performed with Friedman with Dunn-Bonferroni post-hoc test. Differences were deemed statistically significant at p ≤0.05.

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
20 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • systemically healthy
  • non-smoker individuals

排除标准

  • pregnancies or lactation
  • to exposure to antibiotics or any other drugs that were known to affect periodontal conditions over the past 6 months prior to recruitment.
  • to receive previous surgical/nonsurgical periodontal treatment during the previous 12-months.

结局指标

主要结局

Salivary TREM-1 level

时间窗: Change from baseline to one, three and six months after scaling and root planing

Salivary TREM-1 concentration (pg/ml)

Salivary PGLYRP1 level

时间窗: Change from baseline to one, three and six months after scaling and root planing

Salivary PGLYRP1 concentration (ng/ml)

Salivary IL-1β level

时间窗: Change from baseline to one, three and six months after scaling and root planing

Salivary IL-1β concentration (pg/ml)

次要结局

未报告次要终点

研究者

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

Beral Afacan

Assoc. Prof.

Aydin Adnan Menderes University

研究点 (1)

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