RecruitingNCT05950009

Relationship Between Major Depression and Periodontal Diseases

Relationship Between Major Depression and Periodontal Diseases: Analytical Cross-sectional Study


Sponsor

Universidad Complutense de Madrid

Enrollment

122 participants

Start Date

Feb 20, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating the relationship between major depression and gum disease (periodontal disease). Researchers want to understand whether people with serious depression are more likely to have gum disease, which could lead to better dental care for people with mental health conditions. **You may be eligible if...** - You are 18 years of age or older - For the patient group: You have been diagnosed with moderate or severe major depression (PHQ-9 score of 9 or higher), without severe suicidal thoughts - For the comparison group: You do not have a mental health condition and score 5 or below on the PHQ-9 **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have diabetes - You are HIV positive or regularly take anti-inflammatory medications (NSAIDs) - You have another serious mental health diagnosis such as bipolar disorder, schizophrenia, or eating disorders - You have had periodontal treatment in the past year - You have taken antibiotics in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo intervention (observational studies)

No intervention (observational studies)


Locations(2)

Faculty of Dentistry, University Complutense of Madrid (UCM)

Madrid, Spain

Instituto de Psiquiatría y Salud Mental, Hospital Clínico San Carlos

Madrid, Spain

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NCT05950009


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