Longitudinal Assessment of Dentin Sialoprotein and Interleukin-1 Receptor Antagonist in Gingival Crevicular Fluid and Their Relation with External Apical Root Resorption During Fixed Orthodontic Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- 1. To evaluate the relationship between DSP and IL-1RA levels and the severity of external apical root resorption (EARR) at various stages of treatment.
研究概览
简要总结
External apical root resorption (EARR) is a common yet often undetected adverse effect of fixed orthodontic treatment. Despite its typically mild presentation, severe resorption can occur in certain patients, potentially compromising long-term dental health. Current diagnostic modalities, such as radiography, lack the sensitivity to detect early-stage resorption and cannot differentiate between active and inactive resorptive phases. As EARR is multifactorial and influenced by genetic, biological, and mechanical factors, there is a critical demand for accurate, non-invasive diagnostic markers to enable early detection and real-time monitoring of resorptive activity. Emerging evidence highlights the potential of biomarkers such as dentin sialoprotein (DSP) and interleukin-1 receptor antagonist (IL-1RA) in gingival crevicular fluid (GCF) as indicators of resorption severity. However, the variations in these biomarkers throughout fixed orthodontic treatment and their relationship to the severity of root resorption are not yet well understood.
This gap in knowledge underscores the necessity for research to establish the diagnostic utility of DSP and IL-1RA as biomarkers for predicting and assessing root resorption during orthodontic therapy.
Timely identification of teeth prone to severe resorption is essential. Although radiography is the most widely utilized diagnostic method, it has significant limitations, including its inability to identify early resorption stages or differentiate between active and inactive phases. Additionally, radiographic evidence of resorption becomes apparent only after substantial tissue loss, by which time irreversible damage may have occurred. These drawbacks highlight the urgent need for more sensitive, non-invasive, and timely diagnostic approaches.
Gingival crevicular fluid (GCF) has gained attention as a potential medium for identifying biochemical markers that reflect periodontal and resorptive activity. Dentin sialoprotein (DSP), a byproduct of dentin matrix breakdown, is a promising biomarker and has been identified in the GCF of patients undergoing fixed orthodontic therapy. Similarly, interleukin-1 receptor antagonist (IL-1RA), an anti-inflammatory cytokine, plays a pivotal role in regulating inflammatory responses and preventing excessive bone and root resorption. Variation in the concentration of these biomarkers during fixed orthodontic treatment may offer valuable insights into resorptive activity and susceptibility to EARR.
This study aims to address these unmet needs by investigating the dynamic changes in DSP and IL-1RA levels at three clinical time points to assess effect of treatment duration during fixed appliance therapy in patients with Angle’s Class 1 malocclusion with bimaxillary dentoalveolar protrusion who require all first premolar extraction followed by en-masse retraction, thereby identifying reliable, non-invasive biomarkers for early diagnosis and monitoring of EARR. Establishing such biomarkers could minimize reliance on radiography and enable timely interventions and personalized treatment adjustments, reducing the chance of significant root damage and enhancing long-term treatment outcomes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 25.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Patients with complete dentition in the age group 18 to 25 yrs 2 Patients should be having healthy gingival and periodontal status 3 Diagnosed with Angles Class I malocclusion with bimaxillary dentoalveolar protrusion requiring first premolar extraction as part of fixed orthodontic treatment.
排除标准
- •1 Missing molars or any of the anterior teeth.
- •2 Previous history of orthodontic treatment.
- •3 Erupted or unerupted supernumeraries in the maxillary anterior segment.
- •4 Impacted canines and endodontically treated teeth.
- •• Patients with systemic diseases or conditions affecting oral health (e.g., diabetes, periodontal disease, or other chronic inflammatory conditions).
- •• History of avulsion or replantation.
- •• History of prolonged treatment with systemic steroids and NSAIDs.
结局指标
主要结局
1. To evaluate the relationship between DSP and IL-1RA levels and the severity of external apical root resorption (EARR) at various stages of treatment.
时间窗: There are significant changes in the levels of Dentin Sialoprotein (DSP) and Interleukin-1 Receptor Antagonist (IL-1RA) in gingival crevicular fluid (GCF) and the severity of external apical root resorption (EARR) assessed using RVG at three stages of fixed orthodontic treatment (pretreatment, six months, and one year after treatment initiation) in patients with Angle’s Class I malocclusion with bimaxillary dentoalveolar protrusion undergoing first premolar extraction and en-masse retraction
次要结局
- 1. To evaluate the relationship between DSP and IL-1RA levels and the severity of external apical root resorption (EARR) at various stages of treatment(Gingival crevicular fluid (GCF) samples will be collected at three specific clinical time points. The first sample (T0) will be collected before bonding, the second sample (T1) will be collected 6 months after initiation of treatment, and the final sample (T2) will be collected one year after initiation of treatment)
研究者
RAMESH C
MES DENTAL COLLEGE ,PERINTHALMANNA
