Clinical trial NCT06036472: Impact of Periodontal Therapy on Mental Health Parameters
Official title: Impact of Periodontal Therapy on Mental Health Parameters in Patients With Major Depression and Periodontitis: a Pilot Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Depression
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2023-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 treatment on oral, periodontal, and fecal metagenomic microbiomes, and on systemic levels of inflammation (bacterial, viral, and fungal) and their impact on mental health outcomes.

Material and method:

A 6-month pilot randomized controlled clinical trial is designed. The study will be conducted in patients with moderate or severe DM (Patient Health Questionnaire-9 \[PHQ-9\] index of 9 or higher) and stage III-IV periodontitis who will be assigned to two different interventions:

* Test group: standard periodontal treatment consisting of two sessions of supragingival and subgingival debridement (steps 1 and 2) under local anesthesia.
* Control group: periodontal treatment consisting of two sessions of supragingival debridement (step 1) under local anesthesia.

The study will consist of 6 visits:

* Screening visit (v0)
* Baseline visit (v1):

  * In the mental health center: patients will receive a structured clinical interview for the DSM-IV (SCID) and the patient will fill out 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\].
  * At the UCM School of Dentistry: patients will receive a complete periodontal examination (clinical and radiographic). A subgingival microbiological sample, a saliva sample and a blood sample will also be taken.
  * At the participant's home: the stool samples will be deposited by the participants at home in the specific collection vial.
* Intervention visits (v2-3): Two periodontal treatment sessions (test or control) will be carried out one week apart.
* Re-evaluation visit (v4): Six weeks after treatment, all periodontal clinical variables will be recorded.
* Follow-up visits at 3 and 6 months: after periodontal treatment, all the variables recorded at the baseline visit will be taken

Statistical analysis:

Periodontal treatment (test/control) will be considered as the independent variable and the Hamilton scale (HAM-D17) will be considered the primary response variable. The rest of the variables will be considered as secondary variables. A crude bivariate analysis of comparison of means or proportions will be carried out depending on the nature of the variable. In addition, crude and adjusted regression models will be performed.


Eligibility 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.

Primary outcomes:
measure: Hamilton scale (HAM-D17)
timeFrame: Baseline
measure: Hamilton scale (HAM-D17)
timeFrame: 3 months
measure: Hamilton scale (HAM-D17)
timeFrame: 6 months
Secondary outcomes:
measure: Childhood Trauma Questionnaire short form (CTQ-SF)
timeFrame: Baseline
measure: Childhood Trauma Questionnaire short form (CTQ-SF)
timeFrame: 3 months
measure: Childhood Trauma Questionnaire short form (CTQ-SF)
timeFrame: 6 months
measure: UCLA Loneliness Scale (Spanish version)
timeFrame: Baseline
measure: UCLA Loneliness Scale (Spanish version)
timeFrame: 3 months
measure: UCLA Loneliness Scale (Spanish version)
timeFrame: 6 months
measure: The World Health Organization Quality of Life questionnaire (WHOQOL)
timeFrame: Baseline
measure: The World Health Organization Quality of Life questionnaire (WHOQOL)
timeFrame: 3 months
measure: The World Health Organization Quality of Life questionnaire (WHOQOL)
timeFrame: 6 months
measure: Beck Depression Inventory (BDI)
timeFrame: Baseline
measure: Beck Depression Inventory (BDI)
timeFrame: 3 months
measure: Beck Depression Inventory (BDI)
timeFrame: 6 months
measure: Centre for Epidemiologic Studies Depression scale [CES-D]
timeFrame: Baseline
measure: Centre for Epidemiologic Studies Depression scale [CES-D]
timeFrame: 3 months
measure: Centre for Epidemiologic Studies Depression scale [CES-D]
timeFrame: 6 months
measure: Global Assessment of Functioning (GAF) Scale
timeFrame: Baseline
measure: Global Assessment of Functioning (GAF) Scale
timeFrame: 3 months
measure: Global Assessment of Functioning (GAF) Scale
timeFrame: 6 months
Other outcomes:
measure: Plaque index
timeFrame: Baseline
measure: Plaque index
timeFrame: 3 months
measure: Plaque index
timeFrame: 6 months
measure: Bleeding on probing
timeFrame: Baseline
measure: Bleeding on probing
timeFrame: 3 months
measure: Bleeding on probing
timeFrame: 6 months
measure: Suppuration on probing
timeFrame: Baseline
measure: Suppuration on probing
timeFrame: 3 months
measure: Suppuration on probing
timeFrame: 6 months
measure: Probing depth
timeFrame: Baseline
measure: Probing depth
timeFrame: 3 months
measure: Probing depth
timeFrame: 6 months
measure: Recession
timeFrame: Baseline
measure: Recession
timeFrame: 3 months
measure: Recession
timeFrame: 6 months
measure: Number of teeth lost
timeFrame: Baseline
measure: Number of teeth lost
timeFrame: 3 months
measure: Number of teeth lost
timeFrame: 6 months
measure: Microbiological outcomes
timeFrame: Baseline
measure: Microbiological outcomes
timeFrame: 3 months
measure: Microbiological outcomes
timeFrame: 6 months
measure: Plasma levels of inflammatory mediators
timeFrame: Baseline
measure: Plasma levels of inflammatory mediators
timeFrame: 3 months
measure: Plasma levels of inflammatory mediators
timeFrame: 6 months
measure: Saliva samples
timeFrame: Baseline
measure: Saliva samples
timeFrame: 3 months
measure: Saliva samples
timeFrame: 6 months
measure: Stool samples
timeFrame: Baseline
measure: Stool samples
timeFrame: 3 months
measure: Stool samples
timeFrame: 6 months
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: