Evaluation of Salivary and Pulpal Levels of Substance P and Calcitonin Gene-Related Peptide in Relation to Dental Pain, Pulpal Inflammation, and Psychological Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Pulpal Calcitonin Gene-Related Peptide (CGRP) Concentration
研究概览
简要总结
This observational cross-sectional study is designed to evaluate pulpal and salivary levels of Substance P (SP) and Calcitonin Gene-Related Peptide (CGRP) in individuals with and without dental pain. The study aims to assess the associations between neuropeptide levels, pain severity, histopathological pulpal inflammation, and psychological status including depression, anxiety, and stress. By integrating biological and psychosocial parameters, this study seeks to contribute to a comprehensive understanding of the multifactorial nature of dental pain.
详细描述
Dental pain is a multifactorial condition influenced by peripheral inflammatory processes, neurogenic mechanisms, and psychological factors. Neuropeptides such as Substance P (SP) and Calcitonin Gene-Related Peptide (CGRP) are known to play an important role in pain transmission and pulpal inflammatory responses. However, the invasive nature of pulpal sampling limits the routine clinical application of pulpal biomarkers, emphasizing the need to investigate non-invasive biological media such as saliva.
This observational cross-sectional study includes adult participants who require endodontic treatment and are categorized into painful and painless groups based on clinical examination and pain assessment using the Verbal Rating Scale (VRS). Pulp tissue samples are obtained during routine endodontic access procedures, and unstimulated saliva samples are collected before and after the clinical procedure. Levels of SP and CGRP in pulp and saliva samples are measured using enzyme-linked immunosorbent assay (ELISA).
Psychological status is evaluated using the Depression Anxiety Stress Scale-21 (DASS-21) to assess levels of depression, anxiety, and stress. Pulpal inflammation is evaluated through histopathological examination of pulp tissue samples using a semi-quantitative scoring system.
The primary objective of this study is to evaluate the relationship between dental pain and pulpal and salivary neuropeptide levels. Secondary objectives include assessing the associations between neuropeptides, psychological status, pain severity, and histopathological pulpal inflammation. The study is designed to provide descriptive and associative data without intervention, supporting a biopsychosocial framework for understanding dental pain and exploring the potential clinical relevance of salivary biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- 否
入选标准
- •Adults aged 18-65 years
- •ASA physical status I or II
- •Presence of permanent teeth requiring endodontic treatment
- •Ability to understand the study procedures and provide written informed consent
- •No use of analgesic medications within 24 hours prior to clinical assessment
- •No food or drink intake within 2 hours prior to saliva sampling
排除标准
- •Periodontal disease (probing depth >4 mm or bleeding on probing >20%)
- •Systemic inflammatory, autoimmune, neuropathic, or chronic pain disorders
- •Acute infection, fever, or antibiotic use within the last 7 days
- •Pregnancy or lactation
- •Regular use of psychiatric medications (e.g., antidepressants, anxiolytics, antipsychotics, antiepileptics)
- •Tobacco use or alcohol consumption within the last 24 hours
- •Previous endodontic treatment or history of dental trauma in the study tooth
- •Systemic diseases that may affect neuropeptide levels (e.g., diabetes mellitus, thyroid disorders, renal or hepatic disease)
- •Use of medications affecting salivary flow
研究组 & 干预措施
Painful Group
Participants presenting with dental pain who require endodontic treatment and report pain based on clinical examination and Verbal Rating Scale assessment.
Painless Group
Participants without dental pain who require endodontic treatment and report no pain based on clinical examination and Verbal Rating Scale assessment.
结局指标
主要结局
Pulpal Calcitonin Gene-Related Peptide (CGRP) Concentration
时间窗: Periprocedural (single assessment at the time of endodontic access)
Calcitonin Gene-Related Peptide (CGRP) concentration measured in pulpal tissue samples collected during routine endodontic access. CGRP levels are quantified using enzyme-linked immunosorbent assay (ELISA) and expressed as picograms per milligram of pulp tissue (pg/mg). Higher values indicate increased neurogenic activity and pulpal stress.
Salivary Substance P (SP) Concentration - Baseline
时间窗: Baseline (prior to clinical procedure)
Substance P (SP) concentration measured in unstimulated whole saliva samples collected before the clinical procedure. SP levels are analyzed using enzyme-linked immunosorbent assay (ELISA) and expressed as picograms per milliliter (pg/mL). Higher values indicate increased neurogenic and stress-related activity.
Salivary Substance P (SP) Concentration - Periprocedural
时间窗: Periprocedural (immediately after the clinical procedure; single assessment)
Substance P (SP) concentration measured in unstimulated whole saliva samples collected immediately after the clinical procedure. SP levels are analyzed using enzyme-linked immunosorbent assay (ELISA) and expressed as picograms per milliliter (pg/mL). Higher values indicate increased neurogenic and stress-related activity.
次要结局
- Psychological Status - Depression Anxiety Stress Scale-21 (DASS-21)(Baseline (at clinical examination prior to treatment))
- Dental Pain Severity (Verbal Rating Scale - VRS)(Baseline (at clinical examination prior to treatment))
- Histopathological Pulpal Inflammation Score(Periprocedural (after pulp tissue collection during endodontic access))
- Correlation Between Neuropeptide Levels and Psychological Parameters(Baseline (single assessment during study participation))
研究者
Aliye Kamalak
Assoc. Prof.
Kahramanmaras Sutcu Imam University