Evaluation of the Effects of Routine Phase I Periodontal Therapy on Clinical Parameters and Levels of Gremlin-1, CTHRC1, and Tenascin-C in Gingival Crevicular Fluid and Peri-Implant Sulcular Fluid in Individuals With Periodontitis and Peri-Implantitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in GCF and PISF Biomarker Levels (Gremlin-1, CTHRC1, Tenascin-C).
研究概览
简要总结
The aim of this study is to compare the mechanisms of tissue destruction between natural teeth with periodontitis and implants with peri-implantitis within the same individual, and to evaluate the effects of routine Phase I periodontal therapy (scaling and root planing, and oral hygiene instruction). In this study, the tissue biomarker levels of Gremlin-1, CTHRC1, and Tenascin-C will be investigated. Gingival crevicular fluid (GCF) and peri-implant sulcular fluid (PISF) samples will be collected from subjects concurrently diagnosed with both periodontitis and peri-implantitis.
详细描述
The primary objective of this study is to compare the mechanisms of tissue destruction between natural teeth with periodontitis and implants with peri-implantitis within the same individual, and to evaluate the effects of routine Phase I periodontal therapy (scaling and root planing, and oral hygiene instruction)-performed in accordance with standard protocols-on these pathological processes.
Individuals concurrently diagnosed with both periodontitis and peri-implantitis will be included in the study. In our study, the tissue biomarker levels of Gremlin-1, which inhibits bone regeneration via BMP antagonist activity; CTHRC1, which induces osteogenic differentiation by activating the Wnt/β-catenin signaling pathway; and Tenascin-C, which reflects extracellular matrix degradation during the inflammatory process, will be investigated.
Gingival crevicular fluid (GCF) and peri-implant sulcular fluid (PISF) samples will be collected from these subjects prior to treatment (T0) and at the one-month post-treatment follow-up visit (T1). The obtained biomarker levels will be quantitatively analyzed using the enzyme-linked immunosorbent assay (ELISA) method. Through the acquired data, it is aimed to elucidate the differences in bone remodeling (coupling) dynamics around implants compared to the bone metabolism around natural teeth, thereby providing a scientific rationale for the development of novel diagnostic approaches and targeted therapeutic strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Aged between 18 and 65 years and providing written informed consent.
- •Systemically healthy (absence of diabetes, osteoporosis, immunological diseases, etc.).
- •Having a dental implant with prosthetic loading that has been in function for at least 1 year.
- •No history of periodontal treatment within the last 6 months.
- •No use of medications that could affect study outcomes (mouthwashes, antibiotics, non-steroidal anti-inflammatory drugs [NSAIDs], corticosteroids) in the 3 months prior to sampling.
- •For the Test Group: Concurrent presence of both Peri-implantitis (bleeding on probing/suppuration, PD >= 5mm, radiographic bone loss >= 2mm) and Periodontitis (Generalized Stage III-IV, presence of bleeding on probing and clinical attachment loss) in the same oral cavity.
- •For the Control Group: Completely healthy periodontal and peri-implant tissues (negative bleeding on probing, PD <= 3mm, no bone loss), with a low plaque index score (<20%) and good oral hygiene.
排除标准
- •Current use of smoking and tobacco products (or having quit within the last 5 years).
- •History of any periodontal or peri-implant surgical/non-surgical treatment within the last 6 months.
- •Use of antibiotics, anti-inflammatory drugs (NSAIDs), or immunosuppressive drugs within the last 3 months.
- •Pregnancy, lactation (breastfeeding), or use of oral contraceptives.
- •Presence of faulty restorations, overhanging fillings, or removable prosthesis clasps that increase plaque accumulation on the tooth or implant to be examined (to eliminate local factors).
- •Detection of mobility in the implant to be examined (this is considered implant failure/loss, not just peri-implantitis).
- •Presence of active orthodontic treatment (brackets/wires) in the regions where samples will be collected.
研究组 & 干预措施
Periodontitis and Peri-implantitis Group
Patients concurrently diagnosed with both periodontitis and peri-implantitis. Gingival crevicular fluid (GCF) and peri-implant sulcular fluid (PISF) samples will be collected at baseline (T0) and one month post-treatment (T1).
干预措施: Routine Phase I Non-Surgical Periodontal Therapy (Procedure)
Periodontally Healthy Control Group
Volunteers with clinically healthy periodontal and peri-implant tissues. Gingival crevicular fluid (GCF) and peri-implant sulcular fluid (PISF) samples will be collected at a single time point to serve as a healthy baseline reference.
结局指标
主要结局
Change in GCF and PISF Biomarker Levels (Gremlin-1, CTHRC1, Tenascin-C).
时间窗: Baseline (T0) and 1 month post-treatment (T1).
The concentrations of Gremlin-1, CTHRC1, and Tenascin-C proteins in gingival crevicular fluid (GCF) and peri-implant sulcular fluid (PISF) will be quantified using highly sensitive Enzyme-Linked Immunosorbent Assay (ELISA) kits. The values will be measured in picograms per milliliter (pg/mL) to evaluate the immunological response to Phase I therapy.
次要结局
- Change in Probing Pocket Depth (PPD)(Baseline (T0) and 1 month post-treatment (T1).)
- Change in Clinical Attachment Level (CAL)(Baseline (T0) and 1 month post-treatment (T1).)
- Change in Plaque Index (PI).(Baseline (T0) and 1 month post-treatment (T1).)
- Change in Gingival Index (GI)(Baseline (T0) and 1 month post-treatment (T1).)
- Change in Bleeding on Probing (BOP).(Baseline (T0) and 1 month post-treatment (T1).)
研究者
Yusuf Onur Erdem
Research Assistant, Department of Periodontology
Adiyaman University