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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Surfactant Protein D (SP-D) Levels in Gingival Crevicular Fluid
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Laboratory personnel measuring SP-D levels using ELISA will be blinded to the timing of sample collection, whether baseline or 6 months after treatment. Data analysts will also be blinded to the timing of sample collection. Participants and clinicians cannot be blinded because of the nature of the periodontal intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Minimally Invasive Non-Surgical Periodontal Therapy (Procedure)
结局指标
主要结局
Change in Surfactant Protein D (SP-D) Levels in Gingival Crevicular Fluid
时间窗: 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.
次要结局
- Change in Full-Mouth Plaque Score(Baseline and 6 months after treatment)
- Change in Probing Pocket Depth(Baseline and 6 months after treatment)
- Change in Clinical Attachment Level(Baseline and 6 months after treatment)
- Change in Gingival Recession(Baseline and 6 months after treatment)
- Patient Satisfaction Score(6 months after treatment)
研究者
Hossam Ashraf Elmasry
Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
Cairo University