跳至主要内容
临床试验/NCT06589076
NCT06589076
已完成
不适用

Psychological Assessment of Patients With Apical Periodontitis and Caries: A Case-Control Study

University of Siena2 个研究点 分布在 1 个国家目标入组 120 人2022年4月1日

概览

阶段
不适用
干预措施
Clinical and Radiographic assessment + Questionnaires
疾病 / 适应症
Apical Periodontitis
发起方
University of Siena
入组人数
120
试验地点
2
主要终点
Hamilton Anxiety Rating Scale (HAM-A) Score
状态
已完成
最后更新
19天前

概览

简要总结

This study is investigating the relationship between anxiety, depression and apical periodontitis (AP), a common oral inflammatory condition. The research is being conducted at the Unit of Endodontic and Conservative Dentistry, University of Siena, Italy, with participants aged over 18. Participants are divided into two groups: those with apical periodontitis and those without. The study aims to determine whether there is an association between anxiety, depression (assessed using the Hamilton Anxiety/Depression Rating Scale), and the presence or severity of apical periodontitis. Data collection includes dental exams, radiographs, and anxiety and depression assessments. This research may help to better understand how mental health and dental health are connected.

详细描述

The aim of the present case-control study is to evaluate the association between apical periodontitis (AP) and mental health conditions, specifically anxiety and depression. Subjects will be enrolled from the Unit of Endodontics and Conservative Dentistry of the University of Siena. The inclusion criteria of the study are healthy patients older than 18 years, the ability and willingness to give informed consent, and the presence of untreated periapical lesions for the case group. Participants without apical periodontitis will be included in the control group. Participants affected by systemic diseases such as diabetes or rheumatoid arthritis, those using corticosteroid drugs, and those in stage 3 or 4 of periodontitis will be excluded. Additional exclusion criteria include the use of antibiotics within the last 6 months, inability to give informed consent, and pregnancy or lactation. Seventy-one subjects fulfilling the described criteria will be enrolled and allocated into two distinct groups based on the presence or absence of apical periodontitis. Group 1 will consist of patients with radiographic evidence of AP, and Group 2 will consist of healthy controls free from clinical and radiographic signs of AP. The AP+ group will include patients with at least one tooth showing radiographic evidence of apical radiolucency. To perform the initial screening, participants will undergo panoramic radiography, clinical examination, and periapical radiographs using the long cone paralleling technique to assess suspected AP. The following parameters will be recorded: * The number of decayed, missing, and filled teeth (DMFT index) * The number of teeth with apical periodontitis * Periapical Index (PAI) Score All mental health assessments will be conducted using standardized psychiatric scales, including the Hamilton Depression Rating Scale (HAM-D) and the Hamilton Anxiety Rating Scale (HAM-A), to evaluate the severity of depression and anxiety, respectively. Additionally, smoking status (current, former, or non-smoker) will be recorded to explore its association with apical periodontitis and its potential impact on anxiety and depression scores. The results expected from this study are: * A potential correlation between apical periodontitis and increased anxiety and depression scores (HAM-A and HAM-D). * A possible association between smoking habits and the severity of mental health conditions in relation to apical periodontitis. This study may help to elucidate the connection between oral and mental health, highlighting the importance of holistic health care approaches that consider both physical and psychological factors.

注册库
clinicaltrials.gov
开始日期
2022年4月1日
结束日期
2024年4月30日
最后更新
19天前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Simone Grandini

Professore

University of Siena

入排标准

入选标准

  • Ability and willingness to give written consent;
  • Age above 18 years old;
  • Presence of an untreated periapical lesion for the case group;
  • Absence of a periapical lesion for the control group.

排除标准

  • Diabetes;
  • Rheumatoid Arthritis;
  • Use of corticosteroid drugs;
  • Stage 3 and 4 of periodontitis;
  • Inability or unwillingness to give informed consent.

研究组 & 干预措施

Case Group (AP+):

This group consists of participants who have apical periodontitis (AP), an oral inflammatory condition. These participants are diagnosed with AP based on radiographic evidence. They may exhibit symptoms of AP, but AP is often asymptomatic, so radiographic confirmation is key.

干预措施: Clinical and Radiographic assessment + Questionnaires

Control Group (AP-):

This group consists of participants who do not have apical periodontitis (AP). These participants are healthy individuals with no clinical or radiographic signs of apical periodontitis. They will be matched with the case group based on age, gender, and other relevant characteristics, but they will not have any dental lesions related to apical periodontitis.

干预措施: Clinical and Radiographic assessment + Questionnaires

结局指标

主要结局

Hamilton Anxiety Rating Scale (HAM-A) Score

时间窗: At baseline (during participant enrollment and evaluation)

The severity of anxiety symptoms is measured using the Hamilton Anxiety Rating Scale (HAM-A). This scale assesses both psychological (mental distress) and somatic (physical symptoms) aspects of anxiety. Scores range from 0 to 56, with higher scores indicating more severe anxiety. The association between HAM-A scores and the presence of apical periodontitis (AP) will be analyzed.

Hamilton Depression Rating Scale (HAM-D) Score

时间窗: At baseline (during participant enrollment and evaluation)

The severity of depression is assessed using the 17-item Hamilton Depression Rating Scale (HAM-D). The scale evaluates a range of depressive symptoms such as mood disturbances, guilt, insomnia, anxiety, and somatic concerns. Scores range from 0 to 52, with higher scores indicating more severe depression. The association between HAM-D scores and the presence of apical periodontitis (AP) will be analyzed.

Periapical Index (PAI) Score

时间窗: At baseline (during participant enrollment and evaluation)

The Periapical Index (PAI) score is used to assess the severity of apical periodontitis. The score ranges from 1 to 5, with higher scores indicating more severe periapical inflammation. The association between PAI scores and anxiety (HAM-A) and depression (HAM-D) scores will be analyzed.

次要结局

  • Decayed, Missing, and Filled Teeth (DMFT) Index(At baseline (during participant enrollment and evaluation))
  • Smoking Status and Its Association with Mental Health and Oral Health(At baseline (during participant enrollment and evaluation))

研究点 (2)

Loading locations...

相似试验