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Status:

RECRUITING

Impact of Periodontal Therapy on Mental Health Parameters

Lead Sponsor:

Universidad Complutense de Madrid

Collaborating Sponsors:

Ministerio de Economía y Competitividad, Spain

Conditions:

Periodontitis

Depression

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Objectives: Primary: To determine the efficacy of periodontal treatment on mental health outcomes in patients with major depression and periodontitis. Secondary: To identify the effect of periodontal ...

Eligibility Criteria

Inclusion

  • 3.1. Inclusion criteria:
  • Age greater or equal to 18 years.
  • Patients 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.
  • Subjects with periodontitis stages III or IV, according to the 2018 Classification on periodontal and peri-implant diseases (Papapanou et al., 2018).
  • 3.2. 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.
  • Smokers of 10 or more cigarettes per day.
  • Patients who had received periodontal treatment for periodontitis in the last year.
  • Presence of necrotizing periodontal diseases.
  • Presence of less than 3 teeth per quadrant.
  • Antibiotic use in the last 6 months prior to the study.

Exclusion

    Key Trial Info

    Start Date :

    March 14 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    January 1 2026

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT06036472

    Start Date

    March 14 2024

    End Date

    January 1 2026

    Last Update

    May 10 2024

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Faculty of Dentistry, University Complutense of Madrid (UCM)

    Madrid, Spain, 28034

    2

    Instituto de Psiquiatría y Salud Mental, Hospital Clínico San Carlos

    Madrid, Spain, 28040