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临床试验/NCT07127744
NCT07127744尚未招募不适用

Determination of the Relationship Between Orthodontic Malocclusion Severity and Periodontitis Risk Using RANKL, OPG and Oxidative Stress Markers

Recep Tayyip Erdogan University Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Gingival crevicular fluid collection

研究概览

简要总结

The goal of this observational study is to examine the potential relationship between the severity of orthodontic malocclusion and the risk of developing periodontitis in individuals by evaluating salivary and gingival crevicular levels of RANKL, osteoprotegerin (OPG), and oxidative stress biomarkers.

The main question it aims to answer is:

Does increasing severity of orthodontic malocclusion contribute to a higher risk of periodontitis through changes in RANKL/OPG balance and oxidative stress levels?

Participants with different levels of tooth misalignment (malocclusion) will be examined to assess the condition of their teeth and gums. During this examination, information such as dental plaque, gum bleeding, and the depth of gum pockets will be recorded. In addition, fluid samples collected from the gums will be tested in the laboratory to measure certain biological substances and chemical markers related to the body's balance between harmful and protective effects. These measurements will be done using special laboratory tests.

详细描述

The aim of this study is to evaluate the potential relationship between the severity of orthodontic malocclusion and the risk of developing periodontitis through the analysis of RANKL, osteoprotegerin (OPG), and oxidative stress biomarkers. The mechanical effects of malocclusion on teeth and surrounding tissues may lead to inflammation and tissue destruction within the periodontal structures. Understanding the biomolecular mechanisms involved in this process is essential for early diagnosis and preventive approaches.

This cross-sectional study will include individuals with varying degrees of malocclusion severity. Orthodontic status will be determined through clinical evaluation and standardized indices, while periodontal status will be assessed using parameters such as the plaque index, papillary bleeding index, and probing pocket depth. In addition, gingival crevicular fluid (GCF) samples will be collected from participants to measure levels of RANKL, OPG, total antioxidant capacity (TAC), and total oxidative status (TOS) using the ELISA method.

The data obtained will help reveal whether orthodontic abnormalities increase the risk of periodontal disease and how this risk correlates with biomarker levels. The study emphasizes the importance of a holistic evaluation of both orthodontic and periodontal health.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between the ages of 12 and 18,
  • Patients with all permanent teeth,
  • Not having taken antibiotics, steroids, and/or nonsteroidal anti-inflammatory drugs in the last 3 weeks,
  • Not having an active infectious disease,
  • Not having chronic medication use that affects periodontal tissues (cyclosporine A, Phenytoin),
  • Not having taken antioxidant supplements in the last 6 months.

排除标准

  • Presence of any congenital craniofacial deformity (cleft lip and palate or any other craniofacial syndrome or deformity),
  • Patients who have previously started or completed orthodontic treatment,
  • Patients who have received periodontal treatment in the last 6 months,
  • Acute illness,
  • Systemic illness, mental illness, immunosuppressive medications, or immunodeficiency.

结局指标

主要结局

Gingival crevicular fluid collection

时间窗: Day 1

After isolating the teeth with a cotton roll, supragingival plaque will be removed and a gentle airflow will be used to dry the teeth. GCF samples will be collected by inserting PerioPaper strips into the mesiobuccal gingival sulcus to a depth of approximately 1 mm for 30 seconds. A calibrated Periotron 8000 instrument will then be used to measure the total GCF volume. PerioPaper strips will then be stored at -80°C for future measurements.

Periodontal Clinical Parametres (Papillary Bleeding Index)

时间窗: Day 1

Papillary Bleeding Index (PBI) This index is used to assess bleeding of the interdental papilla-an early sign of periodontal disease-in order to evaluate the degree of gingival inflammation. A periodontal probe is gently inserted into each interdental papilla (the triangular-shaped gum tissue between teeth). The probe is placed approximately 1-2 mm into the papilla and directed upward. Bleeding occurring within 10-30 seconds is observed and scored based on severity. The scores from all papillae are totaled and divided by the number of examined sites to obtain the average PBI score. Score Description 0 No bleeding 1. Single-point, slight bleeding 2. Thin line of blood 3. Obvious and rapid bleeding across the entire papilla, slight spreading 4. Severe, profuse bleeding that overflows the papilla, usually with evident inflammation

Periodontal Clinical Parametres (Bleeding on Probing Index)

时间窗: Day 1

Bleeding on Probing (BOP) Index This index is used to assess the presence and severity of gingival inflammation by observing bleeding after gentle pressure is applied to the gingival sulcus using a periodontal probe. A thin periodontal probe is gently inserted into the gingival sulcus with light pressure (approximately 20-25 grams). Bleeding occurring within 10-30 seconds is observed. Each measurement site is recorded as either "bleeding present" or "bleeding absent." Presence of bleeding is an early and sensitive indicator of gingival inflammation. Score Description 0 No bleeding 1 Bleeding present (mild or severe)

Clinical Periodontal Parameters (Plaque Index)

时间窗: Day 1

Plaque Index (PI) This index is used to evaluate the amount of dental plaque accumulation on tooth surfaces. Each tooth's four surfaces (buccal, lingual, mesial, distal) are examined using a probe or visually. Each surface is scored from 0 to 3. The average score is calculated for each tooth. The overall plaque index is obtained by averaging the scores from all examined teeth. Score Description 0 No plaque. 1. No visible plaque, but a slight film of plaque is detected when a probe is run along the gingival margin. 2. Visible plaque along the gingival margin, forming a continuous band. 3. Abundant plaque covering the gingival area and extending toward the middle of the tooth surface, including the interproximal spaces.

Periodontal Clinical Parametres (Probing Pocket Depth)

时间窗: Day 1

Probing Pocket Depth (PPD) Using a Williams periodontal probe, the distance between the marginal gingival margin and the base of the periodontal pocket is measured in millimeters at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual. All teeth are measured. The values obtained from each site are summed and then divided by the total number of sites measured. This gives the average probing depth for the individual. Measurement Interpretation 1-3 mm Healthy sulcus 4-5 mm Shallow to moderate pocket ≥6 mm Deep periodontal pocket (advanced disease)

Periodontal Clinical Parametres (Clinical Attachment Loss)

时间窗: Day 1

Clinical Attachment Loss (CAL) Using a Williams periodontal probe, the distance between the enamel-cementum junction and the base of the periodontal pocket is measured in millimeters at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual. All teeth are measured. The values obtained from each site are summed and then divided by the total number of sites measured. This gives the average probing depth for the individual. CAL Value Interpretation 0-1 mm Healthy / minimal loss 2-3 mm Mild attachment loss 4-5 mm Moderate attachment loss ≥6 mm Severe attachment loss

次要结局

  • Determination of RANKL, OPG, TAS and TAC by ELISA(4th month)

研究者

发起方
Recep Tayyip Erdogan University Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek KARADOĞAN

Assoc. Prof. Dr.

Recep Tayyip Erdogan University Training and Research Hospital

研究点 (1)

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