Clinical trial NCT05950009: Relationship Between Major Depression and Periodontal Diseases
Official title: Relationship Between Major Depression and Periodontal Diseases: Analytical Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Major Depressive Disorder
Periodontitis
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2023-07-18
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief summary: 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:

* Control group (without DM): subjects without known mental health pathologies will be included, who present a PHQ-9 index of 5 or less. They will be recruited from the control group of a population-based study PsychoBioma TRIAD (C.P. PSQ-19-2 - C.I. 19/474-E). They will be matched by age, gender, and socioeconomic status.
* Group of cases (MD patients): subjects with moderate DM will be selected, characterized by HPQ9 index values of 9 or higher. They will be selected among those patients who attend the Mental Health consultations associated with the San Carlos Clinical Hospital.

The study will consist of three visits:

* Visit in Mental Health Consultations: in this visit the subject will be evaluated to determine if he meets the eligibility criteria. You will be informed of the purpose of the study and you will be invited to participate and sign the informed consent. After that, a structured clinical interview for the DSM-IV (SCID) will be conducted and the subject will fill in a series of specific scales on a study-specific electronic device \[Beck Depression Inventory (BDI); UCLA Loneliness Scale, Center for Epidemiologic Studies Depression scale \[CES-D\]; Childhood Trauma Questionnaire short form (CTQ-SF); The World Health Organization Quality of Life questionnaire (WHOQOL); Hamilton scale (HAM-D17); Global Assessment of Functioning (GAF) Scale\].
* Dental School Visit: Subject will receive a comprehensive periodontal examination. A subgingival microbiological sample, a saliva sample and a blood sample will also be taken. The patient will be given a specific vial to collect stool samples.
* At the participant's home: the stool samples will be deposited by the participants at home in the specific collection vial.


Eligibility criteria: Inclusion Criteria:

* Age greater or equal to 18 years.
* For the case group (MD 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.
* For the control group, subjects without mental health pathologies identified by SCID, who present an PHQ-9 index of 5 or below will be included as controls.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Diabetes mellitus.
* Chronic conditions: HIV infection, chronic intake of NSAIDs.
* Comorbidity with other mental disorders: eating disorders, borderline personality disorders, bipolar disorders, schizophrenia and related disorders, and/or any mental serious disease other than major depression.
* Severe suicide ideation.
* Patients who had received periodontal treatment for periodontitis in the last year.
* Presence of necrotizing periodontal diseases.
* Presence of less than three teeth per quadrant.
* Antibiotic use in the last 6 months prior to the study.

Primary outcomes:
measure: Periodontitis (presence/absence)
timeFrame: Baseline
Secondary outcomes:
measure: Childhood Trauma Questionnaire short form (CTQ-SF)
timeFrame: Baseline
measure: UCLA Loneliness Scale (Spanish version)
timeFrame: Baseline
measure: The World Health Organization Quality of Life questionnaire (WHOQOL)
timeFrame: Baseline
measure: Beck Depression Inventory (BDI)
timeFrame: Baseline
measure: Centre for Epidemiologic Studies Depression scale [CES-D]
timeFrame: Baseline
measure: Hamilton scale (HAM-D17)
timeFrame: Baseline
measure: Global Assessment of Functioning (GAF) Scale.
timeFrame: Baseline
measure: Subgingival microbiota
timeFrame: Baseline
measure: Plasma levels of inflammatory mediators
timeFrame: Baseline
measure: Saliva microbiota
timeFrame: Baseline
measure: Gut microbiota (Stool samples)
timeFrame: Baseline
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Faculty of Dentistry, University Complutense of Madrid (UCM)
city: Madrid
country: Spain
facility: Instituto de Psiquiatría y Salud Mental, Hospital Clínico San Carlos
Study officials:
References: