Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT05950009

Relationship Between Major Depression and Periodontal Diseases

Led by Universidad Complutense de Madrid · Updated on 2024-05-10

122

Participants Needed

2

Research Sites

105 weeks

Total Duration

On this page

Sponsors

U

Universidad Complutense de Madrid

Lead Sponsor

M

Ministerio de Economía y Competitividad, Spain

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Relationship Between Major Depression and Periodontal Diseases

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater or equal to 18 years.
  • For the case group, moderate or severe major depression with PHQ-9 score 9 or higher and confirmed by Structured Clinical Interview for DSM-5.
  • For the control group, no mental health disorders confirmed by SCID and PHQ-9 score 5 or below.
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women.
  • Diabetes mellitus.
  • Chronic conditions such as HIV infection or chronic use of NSAIDs.
  • Other mental disorders including eating disorders, borderline personality disorder, bipolar disorder, schizophrenia, or any serious mental illness other than major depression.
  • Severe suicide ideation.
  • Periodontal treatment for periodontitis within the last year.
  • Necrotizing periodontal diseases.
  • Having fewer than three teeth per quadrant.
  • Antibiotic use within the past 6 months.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Faculty of Dentistry, University Complutense of Madrid (UCM)

Madrid, Spain, 28034

Actively Recruiting

2

Instituto de Psiquiatría y Salud Mental, Hospital Clínico San Carlos

Madrid, Spain, 28040

Actively Recruiting

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Research Team

E

Elena Figuero Ruiz, Prof.

CONTACT

J

Juan Carlos Leza Cerro

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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