Impact of Periodontal Therapy on Mental Health Parameters
LeakBrainRCT
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2023
CompletedFirst Posted
Study publicly available on registry
September 14, 2023
CompletedStudy Start
First participant enrolled
March 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedMay 10, 2024
May 1, 2024
1.8 years
July 26, 2023
May 9, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Hamilton scale (HAM-D17)
Range: 0 to 52. The higher the score, the more severethe depressive symptoms
Baseline
Hamilton scale (HAM-D17)
Range: 0 to 52. The higher the score, the more severethe depressive symptoms
3 months
Hamilton scale (HAM-D17)
Range: 0 to 52. The higher the score, the more severethe depressive symptoms
6 months
Secondary Outcomes (18)
Childhood Trauma Questionnaire short form (CTQ-SF)
Baseline
Childhood Trauma Questionnaire short form (CTQ-SF)
3 months
Childhood Trauma Questionnaire short form (CTQ-SF)
6 months
UCLA Loneliness Scale (Spanish version)
Baseline
UCLA Loneliness Scale (Spanish version)
3 months
- +13 more secondary outcomes
Other Outcomes (30)
Plaque index
Baseline
Plaque index
3 months
Plaque index
6 months
- +27 more other outcomes
Study Arms (2)
Subgingival therapy
EXPERIMENTALParticipant 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.
Supragingival therapy
OTHERPeriodontal 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Faculty of Dentistry, University Complutense of Madrid (UCM)
Madrid, 28034, Spain
Instituto de Psiquiatría y Salud Mental, Hospital Clínico San Carlos
Madrid, 28040, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2023
First Posted
September 14, 2023
Study Start
March 14, 2024
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
May 10, 2024
Record last verified: 2024-05