PeriodontitisNCT04260880
Periodontal Assessment in Depression Patients
An observational study of Periodontitis and Depression, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
To assess the periodontal status in the patients with depression. Evaluation of periodontal status in patients with mild depression. Evaluation of periodontal status in patients with moderate depression. Evaluation of periodontal parameters in patients without depression. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Periodontitis, Depression
- What is being tested?
- periodontal status in mild depression patients, periodontal status in moderate depression patients and periodontal status in systemically healthy patients
- How many people
- 135 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2020to 30 Nov 2021
- Phase
- Observational
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: the study patients having mild and moderate depression as well as systemically healthy will be included .
Who may be able to join
- Patients with age 18-50 years
- Newly diagnosed patients of clinical depression (international classification of diseases, classification of Mental and Behavioural Disorders, 10th Revision, Diagnostic criteria for Research35 )
- Having ≥20 natural teeth
Who cannot join
- Systemic disease or condition that is reported to be associated with periodontal disease, including diabetes mellitus, osteoporosis, rheumatoid arthritis, chronic renal failure, cardiovascular disease, and pregnancy
- Treatment with the following drugs in the previous 3 months: antibiotics, anti-inflammatories, steroids, immune-suppressants, lipid-lowering drugs, anticoagulants, bisphosphonates, and host modulatory drugs
- Psychiatric disorder other than depression or any other comorbid psychiatric disorder (organic mental disorder, disorders as a result of psychoactive substance use, schizophrenia and schizoaffective disorder, delirium, delusion, dementia, eating disorders, type 1 or 2 bipolar disorder, neurotic disorder, and psychotic depression)
- Treatment with any antidepressant drug
- Non-surgical or surgical periodontal treatment within the past 6 months before inclusion into the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Periodontal Status in Patients With Depression : A Cross Sectional Study.
To assess the periodontal status in the patients with depression. Evaluation of periodontal status in patients with mild depression. Evaluation of periodontal status in patients with moderate depression. Evaluation of periodontal parameters in patients without depression.
Read the detailed description
Periodontitis, a periodontal disease, results from interaction between the immune system and oral bacteria that may promote oxidative stress and initiate an inflammatory cascade inducing the destruction of the oral structure.
The immune-microbial pathogenesis of periodontitis involves chronic inflammation, which alters the balance among multiple systems, including the neural, immune, and endocrine systems. Multiple systemic conditions, such as diabetes, cardiovascular diseases, and respiratory diseases, have been shown to have an inflammatory association with periodontitis, and pro-inflammatory cytokines such as tumor necrosis factor (TNF)-a, interleukin (IL)-1, and IL-6 are involved. In addition, distress experienced by the patients with periodontitis showed correlation with the progression of periodontitis. Studies have demonstrated that chronic stress and depression fall into a spectrum and could induce dysregulation of the immune system, impairing the course of periodontitis.
Depression, a disabling psychiatric disorder, manifests with depressed mood, vegetative symptoms, and cognitive impairment, and could impair the personal life quality and physical function. In 2015, this mental disorder was classified as the third main cause of global disability . It is a well established and important risk factor for many systemic conditions, including obesity, sleep disturbance, and chronic diseases . In addition to the general health conditions, oral diseases have also been associated with depression . Although some biomarkers were reported to be associated with depression, such as inflammatory cytokines, the serum level of neurotropic factors, and the hypothalamic-pituitary-adrenal (HPA) axis hormone, the clinical use are still unclear.
In the last years, most studies have drawn attention to a contribution of depression to poor oral health status . Conversely, there are researchers investigating a possible influence of oral health conditions on depression suggesting a bi-directional relationship between oral health and mental disorders. Therefore, it can be hypothesized that treatment of periodontitis may lead to improvement in the depression score in patients.
Only few cross-sectional studies have been conducted evaluating association of depression and periodontitis that too in high income countries (Finland, USA and Korea) and the results are inconclusive. So the present study will be conducted in our country to evaluate association of periodontitis and depression to provide high level of evidence.
STUDY DESIGN AND SETTINGS The present cross sectional study will be conducted in the department of Periodontology , PGIDS, Rohtak in collaboration with the department of Psychiatry, PGIMS, Rohtak. This will be an observational cross sectional study.
STUDY PERIOD February 2020 to April 2021
METHOD OF RECRUITMENT Patients in test groups will be recruited from the Outpatient Department of Psychiatry, Post Graduate Institute of Medical Sciences, Rohtak. Patients in control group will be recruited from Department of Oral Medicine and Radiology, Post Graduate Institute of Dental Sciences, Rohtak.
BLINDING/MASKING Single blinding will be adopted where the operator assessing the periodontal parameters will be unaware regarding which group the patient belongs.
PERIODONTAL PARAMETERS :- Indices will be taken at baseline. These will be:- Plaque index Gingival index Probing pocket depth Clinical attachment loss Bleeding on probing
- Conditions
- Periodontitis, Depression
- Being tested
- periodontal status in mild depression patients, periodontal status in moderate depression patients, periodontal status in systemically healthy patients
- Medical subject headings
- Periodontitis, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal status in mild depression patientsOther
Assessment of periodontal status in mild depression patients
periodontal status in moderate depression patientsOther
Assessment of periodontal status in moderate depression patients
periodontal status in systemically healthy patientsOther
Assessment of periodontal status in systemically healthy patients
| Study group | Role | What they receive |
|---|---|---|
| Test group 1 | individuals with mild depression Receives: Other: periodontal status in mild depression patients | |
| Test group 2 | individuals with moderate depression Receives: Other: periodontal status in moderate depression patients | |
| control group | systemically healthy individuals Receives: Other: periodontal status in systemically healthy patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical attachment loss
It will be measured from cemento-enamel junction to base of the pocket.
Measured: 1 year
Secondary outcomes (1)
pocket depth
it will be measured from gingival margin to the base of the pocket
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 Jan 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
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 Postgraduate Institute of Dental Sciences RohtakThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- APARNA KAUSHIK, Principal investigator, POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260880
- Sponsor's protocol ID
- APARNA PGIDS/IEC/2019/31
- Status last verified
- Feb 2022
- First submitted
- 5 Feb 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Periodontal Status in Patients With Depression : A Cross Sectional Study.
- ClinicalTrials.gov ID
- NCT04260880
- Acronym / sponsor ID
- APARNA PGIDS/IEC/2019/31
- Conditions
- Periodontitis, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 7 Feb 2020 (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.
To assess the periodontal status in the patients with depression. Evaluation of periodontal status in patients with mild depression. Evaluation of periodontal status in patients with moderate depression. Evaluation of periodontal parameters in patients without depression.
Detailed description
Periodontitis, a periodontal disease, results from interaction between the immune system and oral bacteria that may promote oxidative stress and initiate an inflammatory cascade inducing the destruction of the oral structure.
The immune-microbial pathogenesis of periodontitis involves chronic inflammation, which alters the balance among multiple systems, including the neural, immune, and endocrine systems. Multiple systemic conditions, such as diabetes, cardiovascular diseases, and respiratory diseases, have been shown to have an inflammatory association with periodontitis, and pro-inflammatory cytokines such as tumor necrosis factor (TNF)-a, interleukin (IL)-1, and IL-6 are involved. In addition, distress experienced by the patients with periodontitis showed correlation with the progression of periodontitis. Studies have demonstrated that chronic stress and depression fall into a spectrum and could induce dysregulation of the immune system, impairing the course of periodontitis.
Depression, a disabling psychiatric disorder, manifests with depressed mood, vegetative symptoms, and cognitive impairment, and could impair the personal life quality and physical function. In 2015, this mental disorder was classified as the third main cause of global disability . It is a well established and important risk factor for many systemic conditions, including obesity, sleep disturbance, and chronic diseases . In addition to the general health conditions, oral diseases have also been associated with depression . Although some biomarkers were reported to be associated with depression, such as inflammatory cytokines, the serum level of neurotropic factors, and the hypothalamic-pituitary-adrenal (HPA) axis hormone, the clinical use are still unclear.
In the last years, most studies have drawn attention to a contribution of depression to poor oral health status . Conversely, there are researchers investigating a possible influence of oral health conditions on depression suggesting a bi-directional relationship between oral health and mental disorders. Therefore, it can be hypothesized that treatment of periodontitis may lead to improvement in the depression score in patients.
Only few cross-sectional studies have been conducted evaluating association of depression and periodontitis that too in high income countries (Finland, USA and Korea) and the results are inconclusive. So the present study will be conducted in our country to evaluate association of periodontitis and depression to provide high level of evidence.
STUDY DESIGN AND SETTINGS The present cross sectional study will be conducted in the department of Periodontology , PGIDS, Rohtak in collaboration with the department of Psychiatry, PGIMS, Rohtak. This will be an observational cross sectional study.
STUDY PERIOD February 2020 to April 2021
METHOD OF RECRUITMENT Patients in test groups will be recruited from the Outpatient Department of Psychiatry, Post Graduate Institute of Medical Sciences, Rohtak. Patients in control group will be recruited from Department of Oral Medicine and Radiology, Post Graduate Institute of Dental Sciences, Rohtak.
BLINDING/MASKING Single blinding will be adopted where the operator assessing the periodontal parameters will be unaware regarding which group the patient belongs.
PERIODONTAL PARAMETERS :- Indices will be taken at baseline. These will be:- Plaque index Gingival index Probing pocket depth Clinical attachment loss Bleeding on probing
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test group 1 | – | Other: periodontal status in mild depression patientsindividuals with mild depression |
| Test group 2 | – | Other: periodontal status in moderate depression patientsindividuals with moderate depression |
| control group | – | Other: periodontal status in systemically healthy patientssystemically healthy individuals |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- the study patients having mild and moderate depression as well as systemically healthy will be included .
Key inclusion criteria (3 listed)
- Patients with age 18-50 years
- Newly diagnosed patients of clinical depression (international classification of diseases, classification of Mental and Behavioural Disorders, 10th Revision, Diagnostic criteria for Research35 )
- Having ≥20 natural teeth
Key exclusion criteria (5 listed)
- Systemic disease or condition that is reported to be associated with periodontal disease, including diabetes mellitus, osteoporosis, rheumatoid arthritis, chronic renal failure, cardiovascular disease, and pregnancy
- Treatment with the following drugs in the previous 3 months: antibiotics, anti-inflammatories, steroids, immune-suppressants, lipid-lowering drugs, anticoagulants, bisphosphonates, and host modulatory drugs
- Psychiatric disorder other than depression or any other comorbid psychiatric disorder (organic mental disorder, disorders as a result of psychoactive substance use, schizophrenia and schizoaffective disorder, delirium, delusion, dementia, eating disorders, type 1 or 2 bipolar disorder, neurotic disorder, and psychotic depression)
- Treatment with any antidepressant drug
- Non-surgical or surgical periodontal treatment within the past 6 months before inclusion into the study
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 |
|---|---|---|
| periodontal status in mild depression patientsAssessment of periodontal status in mild depression patients | Other | Test group 1 |
| periodontal status in moderate depression patientsAssessment of periodontal status in moderate depression patients | Other | Test group 2 |
| periodontal status in systemically healthy patientsAssessment of periodontal status in systemically healthy patients | Other | control group |
Primary outcome
clinical attachment loss
Time frame: 1 year
It will be measured from cemento-enamel junction to base of the pocket.
1 secondary outcome
pocket depth
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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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.
APARNA KAUSHIK principal investigator
POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Depression, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical attachment loss (time frame: 1 year). 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 2 Mar 2022.