Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04260880 |
| Other study ID # |
APARNA PGIDS/IEC/2019/31 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
November 30, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Postgraduate Institute of Dental Sciences Rohtak |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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
