An observational study in Apical Periodontitis, Anxiety and Depression, sponsored by University of Siena. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by University of Siena · Observational
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.
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:
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:
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.
246 studies on the registry are indexed under Periapical Periodontitis; 64 are open to participants now.
This study's enrollment of 120 is above the median of 72 across 33 observational studies indexed under Periapical Periodontitis.
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Participants fulfilling the previously described inclusion criteria will be allocated into two distinct groups based on the presence or absence of apical periodontitis (AP). Group 1 will consist of 36 patients showing radiographic signs of apical periodontitis (AP+), while Group 2 will include 35 healthy individuals (AP-) with no clinical or radiographic evidence of AP, serving as controls. Participants in both groups will be matched based on age, sex, and other relevant characteristics. AP cases will be defined as patients with at least one tooth exhibiting radiographic evidence of apical radiolucency, graded using Peri Apical Index (PAI) Score.
Exclusion Criteria:
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.
Diagnostic Test: Clinical and Radiographic assessment + Questionnaires
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.
Diagnostic Test: Clinical and Radiographic assessment + Questionnaires
* Clinical and radiographic examination to assess oral health and apical periodontitis. * Questionnaires to assess Anxiety and depression.
Hamilton Anxiety Rating Scale (HAM-A) Score
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.
Time frame: At baseline (during participant enrollment and evaluation)
Hamilton Depression Rating Scale (HAM-D) Score
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.
Time frame: At baseline (during participant enrollment and evaluation)
Periapical Index (PAI) Score
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.
Time frame: At baseline (during participant enrollment and evaluation)
Decayed, Missing, and Filled Teeth (DMFT) Index
The DMFT index is recorded to evaluate the overall dental health of participants. It assesses the number of decayed, missing, and filled teeth, providing a comprehensive measure of oral health. The association between DMFT index and anxiety (HAM-A) and depression (HAM-D) scores will be analyzed.
Time frame: At baseline (during participant enrollment and evaluation)
Smoking Status and Its Association with Mental Health and Oral Health
Smoking status (current smoker, former smoker, non-smoker) will be assessed to evaluate its relationship with apical periodontitis and its impact on depression (HAM-D) and anxiety (HAM-A) scores. The analysis will explore whether smoking is a confounding factor in the association between mental health and oral health conditions.
Time frame: At baseline (during participant enrollment and evaluation)
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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University of Siena