Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589076
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Apical Periodontitis and Mental Health
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Correlation of Apical Periodontitis With Anxiety and Depression A University Case-Control Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 AnxietyDepression 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None