Impact of Periodontal Therapy on Mental Health Parameters (LeakBrainRCT)

Universidad Complutense de Madrid

Status: Enrolling

Conditions: Periodontitis; Depression

Treatments: Procedure: supragingival debridement with anesthesia (step 1); Procedure: Standard periodontal therapy (steps 1 & 2)

Study type: Interventional

Funder types: Other

Identifiers

NCT06036472

URI 107-260623

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Subgingival therapy

Experimental group

Description:

Participant will receive standard periodontal treatment consisting of two sessions of supra- and subgingival debridement (steps 1 and 2) under local anesthesia following current guidelines for periodontal therapy in patients with periodontitis (Herrera et al., 2022; Sanz et al., 2020). The use of chlorhexidine (0.12%) and cetylpyridinium chloride (0.05%) mouthwash will be prescribed twice a day for 15 days (Perio-Aid®, Dentaid, Barcelona, Spain). If needed, hopeless teeth might be extracted during this step.

Treatment:

Procedure: Standard periodontal therapy (steps 1 & 2)

Supragingival therapy

Other group

Description:

Periodontal treatment consisting of two sessions of supragingival debridement with anesthesia (step 1) and administration of a placebo mouthwash (FluorAid®, Dentaid, Barcelona, Spain), twice a day for 15 days.

Treatment:

Procedure: supragingival debridement with anesthesia (step 1)