Impact of Periodontal Therapy on Mental Health Parameters
NCT ID: NCT06036472
Last Updated: 2024-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-03-14
2026-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Subgingival therapy
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.
Standard periodontal therapy (steps 1 & 2)
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.
Supragingival therapy
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.
supragingival debridement with anesthesia (step 1)
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.
Interventions
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Standard periodontal therapy (steps 1 & 2)
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.
supragingival debridement with anesthesia (step 1)
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
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Ministerio de Economía y Competitividad, Spain
OTHER_GOV
Universidad Complutense de Madrid
OTHER
Responsible Party
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Locations
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Faculty of Dentistry, University Complutense of Madrid (UCM)
Madrid, , Spain
Instituto de Psiquiatría y Salud Mental, Hospital Clínico San Carlos
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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URI 107-260623
Identifier Type: -
Identifier Source: org_study_id
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