PeriodontitisLeakBrainRCTNCT06036472
Impact of Periodontal Therapy on Mental Health Parameters
A study testing Standard periodontal therapy (steps 1 & 2) and supragingival debridement with anesthesia (step 1) in people with Periodontitis and Depression, run by Universidad Complutense de Madrid at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Depression
- What is being tested?
- Standard periodontal therapy (steps 1 & 2) and supragingival debridement with anesthesia (step 1)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSpain
- Study dates
- 14 Mar 2024to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Faculty of Dentistry, University Complutense of Madrid (UCM)
Madrid, 28034
Elena Figuero Ruiz, 646831548, efigueruiz@gmail.com
Juan Carlos Leza Cerro, 0034913941478, jcleza@ucm.es
- Recruiting
Instituto de Psiquiatría y Salud Mental, Hospital Clínico San Carlos
Madrid, 28040
David Fraguas, davidfraguas@gmail.com
About this study
Official title: Impact of Periodontal Therapy on Mental Health Parameters in Patients With Major Depression and Periodontitis: a Pilot Randomized Controlled Clinical Trial.
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:
Read more
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.
- Conditions
- Periodontitis, Depression
- Being tested
- Standard periodontal therapy (steps 1 & 2), supragingival debridement with anesthesia (step 1)
- Medical subject headings
- Periodontitis, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard periodontal therapy (steps 1 & 2)Procedure or surgery
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)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Standard periodontal therapy (steps 1 & 2) |
| 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. Receives: Procedure: supragingival debridement with anesthesia (step 1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton scale (HAM-D17)
Range: 0 to 52. The higher the score, the more severethe depressive symptoms
Measured: Baseline
Hamilton scale (HAM-D17)
Range: 0 to 52. The higher the score, the more severethe depressive symptoms
Measured: 3 months
Hamilton scale (HAM-D17)
Range: 0 to 52. The higher the score, the more severethe depressive symptoms
Measured: 6 months
Secondary outcomes (18)
Childhood Trauma Questionnaire short form (CTQ-SF)
Range: 25 to 125. A higherscore means more (and worst) traumatic experience
Measured: Baseline
Childhood Trauma Questionnaire short form (CTQ-SF)
Range: 25 to 125. A higherscore means more (and worst) traumatic experience
Measured: 3 months
Childhood Trauma Questionnaire short form (CTQ-SF)
Range: 25 to 125. A higherscore means more (and worst) traumatic experience
Measured: 6 months
UCLA Loneliness Scale (Spanish version)
Range: 20 to 80. Higher scores indicatehigher levels of loneliness
Measured: Baseline
UCLA Loneliness Scale (Spanish version)
Range: 20 to 80. Higher scores indicatehigher levels of loneliness
Measured: 3 months
UCLA Loneliness Scale (Spanish version)
Range: 20 to 80. Higher scores indicatehigher levels of loneliness
Measured: 6 months
The World Health Organization Quality of Life questionnaire (WHOQOL)
Range: o to100. A higher score means better quality of life.
Measured: Baseline
The World Health Organization Quality of Life questionnaire (WHOQOL)
Range: o to100. A higher score means better quality of life.
Measured: 3 months
The World Health Organization Quality of Life questionnaire (WHOQOL)
Range: o to100. A higher score means better quality of life.
Measured: 6 months
Beck Depression Inventory (BDI)
Range: 0 to 63. A higher score means more severe-depressive symptomatology
Measured: Baseline
Beck Depression Inventory (BDI)
Range: 0 to 63. A higher score means more severe-depressive symptomatology
Measured: 3 months
Beck Depression Inventory (BDI)
Range: 0 to 63. A higher score means more severe-depressive symptomatology
Measured: 6 months
Centre for Epidemiologic Studies Depression scale [CES-D]
Range: 0 to 60. Higher scores indicate the presence of more severe symptomatology
Measured: Baseline
Centre for Epidemiologic Studies Depression scale [CES-D]
Range: 0 to 60. Higher scores indicate the presence of more severe symptomatology
Measured: 3 months
Centre for Epidemiologic Studies Depression scale [CES-D]
Range: 0 to 60. Higher scores indicate the presence of more severe symptomatology
Measured: 6 months
Global Assessment of Functioning (GAF) Scale
Range: 1 to 100. A higher scoremeans better functioning. A score of 0 means Inadequate information.
Measured: Baseline
Global Assessment of Functioning (GAF) Scale
Range: 1 to 100. A higher scoremeans better functioning. A score of 0 means Inadequate information.
Measured: 3 months
Global Assessment of Functioning (GAF) Scale
Range: 1 to 100. A higher scoremeans better functioning. A score of 0 means Inadequate information.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start14 Mar 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036472
- Sponsor's protocol ID
- URI 107-260623
- Acronym
- LeakBrainRCT
- Status last verified
- May 2024
- First submitted
- 26 Jul 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Periodontal Therapy on Mental Health Parameters in Patients With Major Depression and Periodontitis: a Pilot Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06036472
- Acronym / sponsor ID
- LeakBrainRCT / URI 107-260623
- Conditions
- Periodontitis, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subgingival therapy | Experimental | Procedure: 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 | Other | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Subgingival therapy |
| 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. | Procedure or surgery | Supragingival therapy |
Primary outcome
Hamilton scale (HAM-D17)
Time frame: Baseline
Range: 0 to 52. The higher the score, the more severethe depressive symptoms
Hamilton scale (HAM-D17)
Time frame: 3 months
Range: 0 to 52. The higher the score, the more severethe depressive symptoms
Hamilton scale (HAM-D17)
Time frame: 6 months
Range: 0 to 52. The higher the score, the more severethe depressive symptoms
18 secondary outcomes
Childhood Trauma Questionnaire short form (CTQ-SF)
Time frame: Baseline
Childhood Trauma Questionnaire short form (CTQ-SF)
Time frame: 3 months
Childhood Trauma Questionnaire short form (CTQ-SF)
Time frame: 6 months
UCLA Loneliness Scale (Spanish version)
Time frame: Baseline
UCLA Loneliness Scale (Spanish version)
Time frame: 3 months
UCLA Loneliness Scale (Spanish version)
Time frame: 6 months
The World Health Organization Quality of Life questionnaire (WHOQOL)
Time frame: Baseline
The World Health Organization Quality of Life questionnaire (WHOQOL)
Time frame: 3 months
The World Health Organization Quality of Life questionnaire (WHOQOL)
Time frame: 6 months
Beck Depression Inventory (BDI)
Time frame: Baseline
Beck Depression Inventory (BDI)
Time frame: 3 months
Beck Depression Inventory (BDI)
Time frame: 6 months
Centre for Epidemiologic Studies Depression scale [CES-D]
Time frame: Baseline
Centre for Epidemiologic Studies Depression scale [CES-D]
Time frame: 3 months
Centre for Epidemiologic Studies Depression scale [CES-D]
Time frame: 6 months
Global Assessment of Functioning (GAF) Scale
Time frame: Baseline
Global Assessment of Functioning (GAF) Scale
Time frame: 3 months
Global Assessment of Functioning (GAF) Scale
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard periodontal therapy (steps 1 & 2) and supragingival debridement with anesthesia (step 1) in people with Periodontitis and Depression, run by Universidad Complutense de Madrid at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Figuero, Prof. (0034913942186, elfiguer@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton scale (HAM-D17) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.