Apical PeriodontitisNCT06589076
Apical Periodontitis and Mental Health
An observational study of Apical Periodontitis and Anxiety, run by University of Siena at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apical Periodontitis, Anxiety, Depression
- What is being tested?
- Clinical and Radiographic assessment + Questionnaires
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2022to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Diabetes;
- Rheumatoid Arthritis;
- Use of corticosteroid drugs;
- Stage 3 and 4 of periodontitis;
- Inability or unwillingness to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychological Assessment of Patients With Apical Periodontitis and Caries: A Case-Control Study
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.
Read the 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
- Being tested
- Clinical and Radiographic assessment + Questionnaires
- Keywords
- Oral Health, Mental Health, Apical Periodontitis, Anxiety, depression, smokers
- Medical subject headings
- Periapical Periodontitis, Anxiety Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and Radiographic assessment + QuestionnairesDiagnostic test
- Clinical and radiographic examination to assess oral health and apical periodontitis.
- Questionnaires to assess Anxiety and depression.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 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. Receives: Diagnostic Test: Clinical and Radiographic assessment + Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At baseline (during participant enrollment and evaluation)
Secondary outcomes (2)
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.
Measured: 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.
Measured: At baseline (during participant enrollment and evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Apr 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Grandini, University of Siena
- Investigators
- Simone Grandini, PhD, DDS, Principal investigator, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589076
- Sponsor's protocol ID
- MHAP001
- Status last verified
- Jan 2022
- First submitted
- 5 Sep 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gaeta C, Tavakkoli A, Carmellini P, Cuomo A, Fagiolini A, Grandini S, Malvicini G, Marruganti C. Psychological Assessment of Patients With Apical Periodontitis and Caries: A Case-Control Study. Int Endod J. 2026 Sep;59(9):1804-1816. doi: 10.1111/iej.70168. Epub 2026 Apr 28.
PubMed 42050649
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Assessment of Patients With Apical Periodontitis and Caries: A Case-Control Study
- ClinicalTrials.gov ID
- NCT06589076
- Acronym / sponsor ID
- MHAP001
- Conditions
- Apical Periodontitis, Anxiety, Depression
- Keywords
- Oral Health, Mental Health, Apical Periodontitis, Anxiety, depression, smokers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group (AP+): | – | Diagnostic Test: Clinical and Radiographic assessment + QuestionnairesThis 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. |
| Control Group (AP-): | – | Diagnostic Test: Clinical and Radiographic assessment + QuestionnairesThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Diabetes;
- Rheumatoid Arthritis;
- Use of corticosteroid drugs;
- Stage 3 and 4 of periodontitis;
- Inability or unwillingness to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and Radiographic assessment + Questionnaires* Clinical and radiographic examination to assess oral health and apical periodontitis. * Questionnaires to assess Anxiety and depression. | Diagnostic test | Case Group (AP+):, Control Group (AP-): |
Primary outcome
Hamilton Anxiety Rating Scale (HAM-A) Score
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Decayed, Missing, and Filled Teeth (DMFT) Index
Time frame: At baseline (during participant enrollment and evaluation)
Smoking Status and Its Association with Mental Health and Oral Health
Time frame: At baseline (during participant enrollment and evaluation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 42050649Gaeta C, Tavakkoli A, Carmellini P, Cuomo A, Fagiolini A, Grandini S, Malvicini G, Marruganti C. Psychological Assessment of Patients With Apical Periodontitis and Caries: A Case-Control Study. Int Endod J. 2026 Sep;59(9):1804-1816. doi: 10.1111/iej.70168. Epub 2026 Apr 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Grandini, PhD, DDS principal investigator
University of Siena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apical Periodontitis and Anxiety, run by University of Siena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale (HAM-A) Score (time frame: At baseline (during participant enrollment and evaluation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06589076, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.