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CompletedNCT04260880Updated Mar 2, 2022

Periodontal Assessment in Depression Patients

An observational study in Periodontitis and Depression, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Completed at 1 site in India. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
135
Ages
18 Years to 50 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Periodontitis
  • Depression
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 135 is above the median of 90 across 428 observational studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak is the lead sponsor of 209 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

the study patients having mild and moderate depression as well as systemically healthy will be included .

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria

  • 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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
135 participants (actual)
Patient registry
No

Groups and cohorts

  • Test group 1

    individuals with mild depression

    Other: periodontal status in mild depression patients

  • Test group 2

    individuals with moderate depression

    Other: periodontal status in moderate depression patients

  • control group

    systemically healthy individuals

    Other: periodontal status in systemically healthy patients

Interventions

  • Otherperiodontal status in mild depression patients

    Assessment of periodontal status in mild depression patients

  • Otherperiodontal status in moderate depression patients

    Assessment of periodontal status in moderate depression patients

  • Otherperiodontal status in systemically healthy patients

    Assessment of periodontal status in systemically healthy patients

06

What researchers measure

Primary outcomes

  1. clinical attachment loss

    It will be measured from cemento-enamel junction to base of the pocket.

    Time frame: 1 year

Secondary outcomes

  1. pocket depth

    it will be measured from gingival margin to the base of the pocket

    Time frame: 1 year

07

Study locations

1 site
  • Post Graduate Institute of Dental Sciences
    Rohtak, Haryana 124001, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04260880
Lead sponsor
Postgraduate Institute of Dental Sciences Rohtak
Responsible party
Sponsor
First posted
Feb 7, 2020
Start date
Jan 1, 2020
Primary completion
Nov 30, 2021
Completion
Nov 30, 2021
Last update
Mar 2, 2022

Study contacts

APARNA KAUSHIK
principal investigator · POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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