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Surfactant Protein D Levels in GCF Before and After MINST in Periodontitis

2026年5月14日 更新者:Hossam Ashraf Elmasry、Cairo University

Evaluation of Surfactant Protein D (SP-D) Levels in the GCF of Periodontitis Patients Associated With the Endpoints After Minimally Invasive Non-surgical Periodontal Therapy: A Before and After Study

This study will evaluate changes in Surfactant Protein D (SP-D) levels in gingival crevicular fluid (GCF) of patients with periodontitis before and after minimally invasive non-surgical periodontal therapy (MINST).

Participants diagnosed with stage II or III periodontitis will receive minimally invasive non-surgical periodontal treatment. GCF samples will be collected at baseline and 6 months after treatment, and SP-D levels will be measured using enzyme-linked immunosorbent assay (ELISA).

The study will also assess clinical periodontal outcomes, including full-mouth plaque score, full-mouth bleeding score, probing pocket depth, clinical attachment level, gingival recession, and patient satisfaction. Each participant will serve as their own control by comparing baseline values with 6-month post-treatment values.

研究概览

详细说明

Periodontitis is a chronic multifactorial inflammatory disease characterized by progressive destruction of the supporting periodontal tissues. Conventional clinical parameters, such as probing pocket depth, bleeding on probing, and clinical attachment level, are useful for diagnosis and follow-up but may reflect tissue destruction after it has already occurred. Therefore, biomarkers that reflect the biological inflammatory status of periodontal tissues may improve monitoring of disease activity and treatment response.

Surfactant Protein D (SP-D) is an innate immune molecule involved in host defense and modulation of inflammation. It has been detected in oral fluids, including gingival crevicular fluid, and may be associated with periodontal inflammation. This study aims to evaluate whether SP-D levels in GCF change after minimally invasive non-surgical periodontal therapy in patients with periodontitis.

This is a single-group before-and-after interventional clinical study. Eligible participants with stage II or III periodontitis will be recruited from the outpatient periodontal clinics of the Faculty of Dentistry, Cairo University. At baseline, periodontal clinical parameters will be recorded, including full-mouth plaque score, full-mouth bleeding score, probing pocket depth, clinical attachment level, and gingival recession. GCF samples will be collected from selected periodontal sites using sterile paper strips and stored until biochemical analysis.

All participants will receive minimally invasive non-surgical periodontal therapy, including oral hygiene instructions, supragingival plaque control, and subgingival instrumentation using minimally invasive techniques. Treatment will be performed using fine periodontal instruments, thin ultrasonic tips, magnification when available, and local anesthesia when needed to improve patient comfort and minimize tissue trauma.

After 6 months, participants will be recalled for clinical re-evaluation and collection of post-treatment GCF samples from the same sites. SP-D levels will be measured using ELISA. The primary outcome will be the change in SP-D level from baseline to 6 months after treatment. Secondary outcomes will include changes in plaque score, bleeding score, probing pocket depth, clinical attachment level, gingival recession, and patient satisfaction.

研究类型

介入性

注册 (估计的)

18

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Cairo、埃及、12613
        • 招聘中
        • Faculty of Dentistry, Cairo University
        • 接触:
          • Faculty of Dentistry, Cairo University
          • 电话号码:01002159535

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

描述

Inclusion Criteria:

  • Male and female participants aged 18 years or older.
  • Diagnosis of periodontitis, classified as stage II or stage III according to the 2018 classification system.
  • Presence of at least one tooth with probing pocket depth (PPD) of 5 mm or more, clinical attachment loss (CAL), and radiographic evidence of bone loss.
  • Presence of at least one intrabony defect with a radiographic intrabony component measuring 3 mm or more.

Exclusion Criteria:

  • Current smokers or individuals with a history of smoking within the past year.
  • Pregnant or lactating women.
  • Use of systemic antibiotics or anti-inflammatory medications within the last 3 months.
  • Known allergy to any materials or agents used during periodontal therapy.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:MINST Group
Participants diagnosed with periodontitis will receive minimally invasive non-surgical periodontal therapy (MINST). Clinical periodontal parameters and gingival crevicular fluid samples will be collected at baseline and 6 months after treatment to assess changes in SP-D levels and periodontal outcomes.
Minimally invasive non-surgical periodontal therapy will include oral hygiene instructions, supragingival plaque control, and subgingival instrumentation using fine periodontal instruments, miniature Gracey curettes, thin ultrasonic tips, magnification when available, and local anesthesia when needed. Debridement will be performed for periodontal pockets while minimizing trauma to the soft tissues.
其他名称:
  • MINST

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Surfactant Protein D (SP-D) Levels in Gingival Crevicular Fluid
大体时间:Baseline and 6 months after treatment
Change in Surfactant Protein D (SP-D) concentration in gingival crevicular fluid from baseline to 6 months after minimally invasive non-surgical periodontal therapy. SP-D levels will be measured using enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL.
Baseline and 6 months after treatment

次要结果测量

结果测量
措施说明
大体时间
Change in Full-Mouth Plaque Score
大体时间:Baseline and 6 months after treatment
Change in full-mouth plaque score from baseline to 6 months after treatment. Plaque score will be recorded as the percentage of sites with visible plaque.
Baseline and 6 months after treatment
Change in Probing Pocket Depth
大体时间:Baseline and 6 months after treatment
Change in probing pocket depth from baseline to 6 months after treatment. Probing pocket depth will be measured in millimeters using a UNC-15 periodontal probe.
Baseline and 6 months after treatment
Change in Clinical Attachment Level
大体时间:Baseline and 6 months after treatment
Change in clinical attachment level from baseline to 6 months after treatment. Clinical attachment level will be measured in millimeters using a UNC-15 periodontal probe.
Baseline and 6 months after treatment
Change in Gingival Recession
大体时间:Baseline and 6 months after treatment
Change in gingival recession from baseline to 6 months after treatment. Gingival recession will be measured in millimeters from the cemento-enamel junction to the gingival margin using a UNC-15 periodontal probe.
Baseline and 6 months after treatment
Patient Satisfaction Score
大体时间:6 months after treatment
Patient satisfaction will be assessed at the 6-month follow-up using a standardized 5-point Likert-scale questionnaire. Higher scores indicate greater patient satisfaction.
6 months after treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月14日

初级完成 (估计的)

2027年2月1日

研究完成 (估计的)

2027年2月1日

研究注册日期

首次提交

2026年5月14日

首先提交符合 QC 标准的

2026年5月14日

首次发布 (实际的)

2026年5月20日

研究记录更新

最后更新发布 (实际的)

2026年5月20日

上次提交的符合 QC 标准的更新

2026年5月14日

最后验证

2026年5月1日

更多信息

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