Evaluation of the Effects of Non-Surgical Periodontal Therapy on Serum and Gingival Crevicular Fluid Levels of Glycoprotein Non-Metastatic B (GPNMB), TGF-β1, RANKL, and Osteoprotegerin in Patients With Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 主要终点
- Change in Gingival Crevicular Fluid (GCF) Glycoprotein Non-Metastatic B (GPNMB) Concentration
研究概览
简要总结
The goal of this study is to learn how a standard treatment called Scaling and Root Planing (SRP) affects specific biochemical markers in people with advanced gum disease (periodontitis). Periodontitis is a chronic condition that can lead to tooth loss.
The main focus is to investigate a marker called Glycoprotein Non-Metastatic B (GPNMB). This is the first study to examine GPNMB levels in both the serum and the gingival crevicular fluid of people with this condition. The study aims to answer these main questions:
How do GPNMB levels change after the Scaling and Root Planing treatment?
How does GPNMB relate to other markers that control bone health and healing, such as TGF-β1, RANKL, and Osteoprotegerin?
Researchers will compare 28 participants with advanced gum disease (Stage III Grade B/C) to 28 participants with healthy gums to see how these markers differ.
Participants in the gum disease group will:
Provide samples for laboratory analysis at the start of the study.
Receive the standard mechanical treatment of their teeth and roots (Scaling and Root Planing).
Return for follow-up visits 6 weeks and 3 months after treatment to provide new samples and have their gum health checked.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy individuals
- •Individuals diagnosed with Stage III Grade B or Grade C periodontitis (for the periodontitis group)
- •Periodontally healthy individuals (for the healthy control group)
- •Participants aged 18 years and older
排除标准
- •Individuals who have received periodontal treatment within the last 6 months
- •Individuals who have used antibacterial drugs within the last 6 months
- •Individuals with any systemic disease
- •Individuals who use medications on a regular basis
- •Current smokers
- •Pregnant individuals
- •Participants under the age of 18 years
研究组 & 干预措施
Periodontitis Group
Participants with Stage III Grade B/C periodontitis. At baseline, clinical periodontal measurements are recorded, and serum and gingival crevicular fluid samples are collected. All participants receive non-surgical periodontal therapy consisting of Scaling and Root Planing (SRP). Follow-up visits are conducted at 6 weeks and 3 months post-treatment for repeated clinical assessments and sample collection to evaluate changes in biochemical markers (GPNMB, TGF-β1, RANKL, and OPG).
干预措施: Scaling and Root Planing (SRP) (Procedure)
Healthy Control Group
Periodontally healthy individuals. Participants undergo a single clinical periodontal examination and provide serum and gingival crevicular fluid samples at the baseline visit. This group serves as a reference for baseline biochemical marker levels. No therapeutic intervention is performed.
结局指标
主要结局
Change in Gingival Crevicular Fluid (GCF) Glycoprotein Non-Metastatic B (GPNMB) Concentration
时间窗: Baseline, 6 weeks, and 3 months post-treatment.
Concentration of GPNMB in gingival crevicular fluid samples measured by Enzyme-Linked Immunosorbent Assay (ELISA). Results will be expressed in picograms per microliter (pg/µL) to evaluate the local biochemical response following scaling and root planing (SRP).
Change in Serum Glycoprotein Non-Metastatic B (GPNMB) Concentration
时间窗: Baseline, 6 weeks post-treatment, and 3 months post-treatment.
Concentration of GPNMB in serum samples measured by Enzyme-Linked Immunosorbent Assay (ELISA) to evaluate the systemic biochemical response. The results will be quantified and reported in picograms per milliliter (pg/mL) to evaluate the change in mean concentration values across the specified measurement intervals.
Change in Gingival Crevicular Fluid (GCF) Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) Concentration
时间窗: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Concentration of RANKL in gingival crevicular fluid samples measured via ELISA to assess local bone resorption activity. The data will be quantified in picograms per microliter (pg/µL) at baseline and post-treatment intervals.
Change in Serum Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) Concentration
时间窗: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Concentration of RANKL in serum samples measured by ELISA to evaluate the systemic bone resorption activity. The results will be quantified and reported in picograms per milliliter (pg/mL) to evaluate the change in mean concentration values across the specified measurement intervals following periodontal therapy.
Change in Gingival Crevicular Fluid (GCF) Osteoprotegerin (OPG) Concentration
时间窗: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Concentration of OPG in gingival crevicular fluid samples measured by ELISA to assess the local bone-protective response. The results will be quantified and reported in picograms per microliter (pg/µL) to evaluate the change in mean concentration values across the specified measurement intervals following scaling and root planing (SRP).
Change in Serum Osteoprotegerin (OPG) Concentration
时间窗: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Concentration of OPG in serum samples measured by ELISA to evaluate the systemic bone-protective response. Measurement values will be reported in picograms per milliliter (pg/mL) to compare the changes in mean concentration values across the specified measurement intervals following periodontal therapy.
Change in Gingival Crevicular Fluid (GCF) Transforming Growth Factor beta 1 (TGF-β1) Concentration
时间窗: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Concentration of TGF-β1 in gingival crevicular fluid samples measured by Enzyme-Linked Immunosorbent Assay (ELISA). This analysis evaluates the local anti-inflammatory response and tissue healing following scaling and root planing (SRP). The results will be quantified and reported in picograms per microliter (pg/µL) to evaluate the change in mean concentration values across the specified measurement intervals.
Change in Serum Transforming Growth Factor beta 1 (TGF-β1) Concentration
时间窗: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Concentration of TGF-β1 in serum samples measured by ELISA to evaluate the systemic anti-inflammatory response. Measurement values will be reported in picograms per milliliter (pg/mL) to compare the changes before and after scaling and root planing (SRP).
次要结局
- Change in Probing Pocket Depth (PPD)(Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.)
- Change in Clinical Attachment Loss (CAL)(Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.)
- Change in Plaque Index (PI)(Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.)
- Change in Gingival Index (GI)(Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.)
研究者
Özlem SARAÇ ATAGÜN
Associate Professor
Saglik Bilimleri Universitesi