Apical Periodontitis and Mental Health

NCT ID: NCT06589076

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 71 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-11
• Study Completion Date: 2024-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Apical Periodontitis; Anxiety; Depression

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Clinical and Radiographic assessment + Questionnaires

Intervention Type: DIAGNOSTIC_TEST

• Clinical and radiographic examination to assess oral health and apical periodontitis.
• Questionnaires to assess Anxiety and depression.

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.

Clinical and Radiographic assessment + Questionnaires

Intervention Type: DIAGNOSTIC_TEST

• Clinical and radiographic examination to assess oral health and apical periodontitis.
• Questionnaires to assess Anxiety and depression.

Interventions

Clinical and Radiographic assessment + Questionnaires

• Clinical and radiographic examination to assess oral health and apical periodontitis.
• Questionnaires to assess Anxiety and depression.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Siena

OTHER

Sponsor Role: lead

Responsible Party

Simone Grandini

Professore

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone Grandini, PhD, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Siena

Locations

Azienda Ospedaliera Universitaria Senese

Siena, Tuscany, Italy

Countries

Italy

Other Identifiers

MHAP001

Identifier Type: -

Identifier Source: org_study_id