Effect of gum treatment on mental health in depressed patients
Impact of Periodontal Therapy on Mental Health Parameters in Patients With Major Depression and Periodontitis: a Pilot Randomized Controlled Clinical Trial.
This study is testing if gum treatment can improve mental health in people with major depression and gum disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Complutense de Madrid Academic / other |
| Locations | 2 sites (Madrid and 1 other locations) |
| Trial ID | NCT06036472 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of periodontal therapy on mental health outcomes in individuals suffering from major depression and periodontitis. Participants will be randomly assigned to receive either standard periodontal treatment or a limited version of the treatment over a six-month period. The study will also explore the impact of these treatments on oral and gut microbiomes, as well as systemic inflammation levels, to understand their relationship with mental health. The primary focus is on patients with moderate to severe depression and advanced stages of periodontitis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with moderate to severe major depression and stage III or IV periodontitis.
Not a fit: Patients with severe suicide ideation, other significant mental disorders, or chronic conditions like diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how treating gum disease may improve mental health in patients with depression.
How similar studies have performed: While the relationship between oral health and mental health is being explored, this specific approach combining periodontal treatment with mental health outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
5.3.1. 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). 5.3.2. 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.
Where this trial is running
Madrid and 1 other locations
- Faculty of Dentistry, University Complutense of Madrid (UCM) — Madrid, Spain (Recruiting)
- Instituto de Psiquiatría y Salud Mental, Hospital Clínico San Carlos — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Elena Figuero, Prof.
- Email: elfiguer@ucm.es
- Phone: 0034913942186
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.