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| Name | Class |
|---|---|
| Ministerio de Economía y Competitividad, Spain | OTHER_GOV |
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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:
The study will consist of 6 visits:
Screening visit (v0)
Baseline visit (v1):
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subgingival therapy | Experimental | 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 | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard periodontal therapy (steps 1 & 2) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Childhood Trauma Questionnaire short form (CTQ-SF) | Range: 25 to 125. A higherscore means more (and worst) traumatic experience | Baseline |
| Childhood Trauma Questionnaire short form (CTQ-SF) | Range: 25 to 125. A higherscore means more (and worst) traumatic experience |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index | presence/absence | Baseline |
| Plaque index | presence/absence | 3 months |
5.3.1. Inclusion criteria:
5.3.2. Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena Figuero, Prof. | Contact | 0034913942186 | elfiguer@ucm.es | |
| Juan Carlos Leza Cerro, Prof. | Contact | 0034913941478 | jcleza@ucm.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, University Complutense of Madrid (UCM) | Recruiting | Madrid | 28034 | Spain |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D003863 | Depression |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000758 | Anesthesia |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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|
| supragingival debridement with anesthesia (step 1) | Procedure | 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. |
|
| 3 months |
| Childhood Trauma Questionnaire short form (CTQ-SF) | Range: 25 to 125. A higherscore means more (and worst) traumatic experience | 6 months |
| UCLA Loneliness Scale (Spanish version) | Range: 20 to 80. Higher scores indicatehigher levels of loneliness | Baseline |
| UCLA Loneliness Scale (Spanish version) | Range: 20 to 80. Higher scores indicatehigher levels of loneliness | 3 months |
| UCLA Loneliness Scale (Spanish version) | Range: 20 to 80. Higher scores indicatehigher levels of loneliness | 6 months |
| The World Health Organization Quality of Life questionnaire (WHOQOL) | Range: o to100. A higher score means better quality of life. | Baseline |
| The World Health Organization Quality of Life questionnaire (WHOQOL) | Range: o to100. A higher score means better quality of life. | 3 months |
| The World Health Organization Quality of Life questionnaire (WHOQOL) | Range: o to100. A higher score means better quality of life. | 6 months |
| Beck Depression Inventory (BDI) | Range: 0 to 63. A higher score means more severe-depressive symptomatology | Baseline |
| Beck Depression Inventory (BDI) | Range: 0 to 63. A higher score means more severe-depressive symptomatology | 3 months |
| Beck Depression Inventory (BDI) | Range: 0 to 63. A higher score means more severe-depressive symptomatology | 6 months |
| Centre for Epidemiologic Studies Depression scale [CES-D] | Range: 0 to 60. Higher scores indicate the presence of more severe symptomatology | Baseline |
| Centre for Epidemiologic Studies Depression scale [CES-D] | Range: 0 to 60. Higher scores indicate the presence of more severe symptomatology | 3 months |
| Centre for Epidemiologic Studies Depression scale [CES-D] | Range: 0 to 60. Higher scores indicate the presence of more severe symptomatology | 6 months |
| Global Assessment of Functioning (GAF) Scale | Range: 1 to 100. A higher scoremeans better functioning. A score of 0 means Inadequate information. | Baseline |
| Global Assessment of Functioning (GAF) Scale | Range: 1 to 100. A higher scoremeans better functioning. A score of 0 means Inadequate information. | 3 months |
| Global Assessment of Functioning (GAF) Scale | Range: 1 to 100. A higher scoremeans better functioning. A score of 0 means Inadequate information. | 6 months |
| Plaque index |
presence/absence |
| 6 months |
| Bleeding on probing | Assessed dichotomously within 15 seconds after probing | Baseline |
| Bleeding on probing | Assessed dichotomously within 15 seconds after probing | 3 months |
| Bleeding on probing | Assessed dichotomously within 15 seconds after probing | 6 months |
| Suppuration on probing | Assessed dichotomously post-probing | Baseline |
| Suppuration on probing | Assessed dichotomously post-probing | 3 months |
| Suppuration on probing | Assessed dichotomously post-probing | 6 months |
| Probing depth | Defined as the distance in mm between the bottom of the pocket and the gingival margin | Baseline |
| Probing depth | Defined as the distance in mm between the bottom of the pocket and the gingival margin | 3 months |
| Probing depth | Defined as the distance in mm between the bottom of the pocket and the gingival margin | 6 months |
| Recession | defined as the distance in mm between the amelocemental boundary and the gingival margin. | Baseline |
| Recession | defined as the distance in mm between the amelocemental boundary and the gingival margin. | 3 months |
| Recession | defined as the distance in mm between the amelocemental boundary and the gingival margin. | 6 months |
| Number of teeth lost | Baseline |
| Number of teeth lost | 3 months |
| Number of teeth lost | 6 months |
| Microbiological outcomes | Subgingival biofilm samples will be taken from samples of gingival crevicular fluid. DNA samples will be frozen at -20°C and preserved until further analysis by quantitative polymerase chain reaction (q-PCR) and 16S rRNA sequencing, using the Illumina MiSeq platform | Baseline |
| Microbiological outcomes | Subgingival biofilm samples will be taken from samples of gingival crevicular fluid. DNA samples will be frozen at -20°C and preserved until further analysis by quantitative polymerase chain reaction (q-PCR) (Marín et al., 2019) and 16S rRNA sequencing, using the Illumina MiSeq platform | 3 months |
| Microbiological outcomes | Subgingival biofilm samples will be taken from samples of gingival crevicular fluid. DNA samples will be frozen at -20°C and preserved until further analysis by quantitative polymerase chain reaction (q-PCR) (Marín et al., 2019) and 16S rRNA sequencing, using the Illumina MiSeq platform | 6 months |
| Plasma levels of inflammatory mediators | Interleukin-1β, Tumor Necrosis Factor-α, prostaglandin-E2, C reactive protein, D-Lactate and intestinal-type fatty acid binding protein 2 [FABP2]), lipopolysaccharide (LPS). matrix metalloproteinase (MMP)-9 levels, S-100B protein levels, quinolinic acid levels, and the ratio between kynurenic and quinolinic acid | Baseline |
| Plasma levels of inflammatory mediators | Interleukin-1β, Tumor Necrosis Factor-α, prostaglandin-E2, C reactive protein, D-Lactate and intestinal-type fatty acid binding protein 2 [FABP2]), lipopolysaccharide (LPS). matrix metalloproteinase (MMP)-9 levels, S-100B protein levels, quinolinic acid levels, and the ratio between kynurenic and quinolinic acid | 3 months |
| Plasma levels of inflammatory mediators | Interleukin-1β, Tumor Necrosis Factor-α, prostaglandin-E2, C reactive protein, D-Lactate and intestinal-type fatty acid binding protein 2 [FABP2]), lipopolysaccharide (LPS). matrix metalloproteinase (MMP)-9 levels, S-100B protein levels, quinolinic acid levels, and the ratio between kynurenic and quinolinic acid | 6 months |
| Saliva samples | Oral microbial DNA will be used for library preparation and metagenomic shotgun sequencing using the Illumina HiSeq 2500 System. Shotgun metagenomic sequencing can identify bacteria, fungi, and viruses, with a resolution that allows species-level identification. Sequences will be compared to phylogenetic and functional databases to obtain taxonomic and functional profiles. | Baseline |
| Saliva samples | Oral microbial DNA will be used for library preparation and metagenomic shotgun sequencing using the Illumina HiSeq 2500 System. Shotgun metagenomic sequencing can identify bacteria, fungi, and viruses, with a resolution that allows species-level identification. Sequences will be compared to phylogenetic and functional databases to obtain taxonomic and functional profiles. | 3 months |
| Saliva samples | Oral microbial DNA will be used for library preparation and metagenomic shotgun sequencing using the Illumina HiSeq 2500 System. Shotgun metagenomic sequencing can identify bacteria, fungi, and viruses, with a resolution that allows species-level identification. Sequences will be compared to phylogenetic and functional databases to obtain taxonomic and functional profiles. | 6 months |
| Stool samples | Gut microbial DNA will be used for library preparation and metagenomic shotgun sequencing using the Illumina HiSeq 2500 System. Shotgun metagenomic sequencing can identify bacteria, fungi, and viruses, with a resolution that allows species-level identification. Sequences will be compared to phylogenetic and functional databases to obtain taxonomic and functional profiles. | Baseline |
| Stool samples | Gut microbial DNA will be used for library preparation and metagenomic shotgun sequencing using the Illumina HiSeq 2500 System. Shotgun metagenomic sequencing can identify bacteria, fungi, and viruses, with a resolution that allows species-level identification. Sequences will be compared to phylogenetic and functional databases to obtain taxonomic and functional profiles. | 3 months |
| Stool samples | Gut microbial DNA will be used for library preparation and metagenomic shotgun sequencing using the Illumina HiSeq 2500 System. Shotgun metagenomic sequencing can identify bacteria, fungi, and viruses, with a resolution that allows species-level identification. Sequences will be compared to phylogenetic and functional databases to obtain taxonomic and functional profiles. | 6 months |
| Instituto de Psiquiatría y Salud Mental, Hospital Clínico San Carlos | Recruiting | Madrid | 28040 | Spain |
|
| D001519 |
| Behavior |