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| Name | Class |
|---|---|
| Ministerio de Economía y Competitividad, Spain | OTHER_GOV |
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Background: There are epidemiological and preclinical studies in vivo that support the biological plausibility of the association between periodontal diseases and major depression (DM), through the hypothesis of a "leaky mouth" by periodontitis as a source of neuroinflammation. Therefore, this association should be studied in depth in carefully designed cross-sectional studies in humans to specifically assess this relationship.
Objectives: Primary: determine if periodontitis can be associated with the development of DM. Secondary: (1) to estimate the prevalence of periodontal diseases (gingivitis and periodontitis) in patients with and without DM; (2) to determine whether oral, periodontal, and fecal (bacterial, viral, and fungal) metagenomic microbiomes, inflammatory mediators, and intestinal barrier integrity are associated with periodontal and mental health variables.
Material and method:
A cross-sectional analytical study with two groups is designed:
The study will consist of three visits:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases _major depression patients | subjects with moderate or severe major depression, without severe suicide ideation, as characterized by the Patient Health Questionnaire (PHQ)-9 index (values of 9 or greater) and by the Structured Clinical Interview for DSM-5 - (SCID) will be selected. |
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| Controls | subjects without mental health pathologies identified by SCID, who present an PHQ-9 index of 5 or below will be included as controls. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention (observational studies) | Other | No intervention (observational studies) |
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| Measure | Description | Time Frame |
|---|---|---|
| Periodontitis (presence/absence) | With the clinical and radiological information, the periodontal diagnosis of the patients will be established according to the 2018 classification of periodontal and peri-implant diseases), which involves determining the stage (I to IV), the extent of the stage (localized, generalized or incisor-molar pattern) and the grade (A, B or C). | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Childhood Trauma Questionnaire short form (CTQ-SF) | Range: 25 to 125. A higher score means more (and worst) traumatic experience. | Baseline |
| UCLA Loneliness Scale (Spanish version) | Range: 20 to 80. Higher scores indicatehigher levels of loneliness |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects in the case group - MD group- will be selected from those patients seen at the Outpatient Clinic of Institute of Psychiatry and Mental Health of Hospital Clínico San Carlos.
Subjects in the control group - Non MD group- will be recruited from the control group of a population-based study PsicoBioma TRIAD (C.P. PSQ-19-2 - C.I. 19/474-E) that is currently being performed by the lab of JCL. They will be matched on age, gender, and socio-economic status. In order to confirm that they are in good mental health, they will receive a pre-screen, online questionnaire to screen for symptoms of anxiety and depression (PHQ-9, STAI).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena Figuero Ruiz, Prof. | Contact | 0034913942186 | elfiguer@ucm.es | |
| Juan Carlos Leza Cerro | Contact | 0034913941478 | jcleza@ucm.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, University Complutense of Madrid (UCM) | Recruiting | Madrid | 28034 | Spain |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010510 | Periodontal Diseases |
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| Baseline |
| The World Health Organization Quality of Life questionnaire (WHOQOL) | Range: 0 to100. A higher score means better quality of life. | Baseline |
| Beck Depression Inventory (BDI) | Range: 0 to 63. A higher score means more severe-depressive symptomatology | Baseline |
| Centre for Epidemiologic Studies Depression scale [CES-D] | Range: 0 to 60. Higher scores indicate the presence of more severe symptomatology | Baseline |
| Hamilton scale (HAM-D17) | Range: 0 to 52. The higher the score, the more severe the depressive symptoms | Baseline |
| Global Assessment of Functioning (GAF) Scale. | Range: 1 to 100. A higher score means better functioning. A score of 0 means Inadequate information. | Baseline |
| Subgingival microbiota | Bacterial DNA extraction will be performed using a commercial kit (Molzym Gmbh& Co.KG; Bremen, Germany) specific for bacterial DNA extraction. DNA samples will be frozen at -80°C and preserved until further analysis by quantitative polymerase chain reaction (q-PCR) (Marin et al., 2019) and 16S rRNA sequencing, using the Illumina MiSeq platform. The analysis of sequences obtained for the microbiome will include: a) quality control and trimming: PCR primers, chimeric sequences, and short and low-quality reads will be discarded; b) mapping: annotation at different taxonomic levels; c) rarefaction curves; d) quantification: counts and percentages of the presence of specific bacteria in each sample at different taxonomic levels; e) calculation of the biodiversity index and f) comparison between samples. The analysis by q-PCR will include the detection and quantification of the most prevalent or abundant species. | Baseline |
| Plasma levels of inflammatory mediators | plasma levels of inflammatory mediators IL-1β, TNF-α, IL-6, prostaglandin E2 and CPRhs | Baseline |
| Saliva microbiota | microbial DNA will be used for library preparation and metagenomic shotgun sequencing using the Illumina HiSeq 2500 System. Shotgun metagenomic sequencing can identify bacteria, fungi, and viruses, with a resolution that allows species-level identification. Sequences are compared to phylogenetic and functional databases to obtain taxonomic and functional profiles | Baseline |
| Gut microbiota (Stool samples) | microbial DNA will be used for library preparation and metagenomic shotgun sequencing using the Illumina HiSeq 2500 System. Shotgun metagenomic sequencing can identify bacteria, fungi, and viruses, with a resolution that allows species-level identification. Sequences are compared to phylogenetic and functional databases to obtain taxonomic and functional profiles | Baseline |
| Instituto de Psiquiatría y Salud Mental, Hospital Clínico San Carlos | Recruiting | Madrid | 28040 | Spain |
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| D009059 |
| Mouth Diseases |
| D009057 | Stomatognathic Diseases |