Serum Cortisol Levels in Patients With Anxiety and Depression With Symptomatic Oral Lichen Planus

Assessment of Anxiety and Depression in Symptomatic Oral Lichen Planus

Oral lichen planus (OLP) is a T-cell mediated chronic immunological disease directed to a still unknown antigen. It is a mucocutaneous and a psychosomatic disorder, with unknown prevalence rate; however studies suggest an incidence of 0.02 to 0.22% among the Indian population. 75% of patients with cutaneous lichen planus also experience oral lesions and may be precipitated or exacerbated by psychosocial stressors.

In conditions like pain, anxiety and stress, many metabolic and endocrine changes occur in the body, the most common effect of which is increased cortisol level in blood. This hormone is a 21-carbon corticosteroid secreted by adrenal cortex and regulates the metabolism of carbohydrates, fats, proteins and water. Also known as stress hormone, cortisol is a decisive index in stressful situations.

This study is intended to correlate the serum cortisol levels with anxiety and depression in patients with symptomatic oral lichen planus. This study attempts to evaluate psychological anxiety and depression in oral lichen planus subjects using Hospital Anxiety and Depression Scale ( HADS) and correlating with their serum cortisol levels.

To understand and explore the etiopathogenesis for better management of oral lichen planus.

Study Overview

• Status: Completed
• Conditions: Oral Lichen Planus Related Stress
• Intervention / Treatment: Procedure: venepuncture

Detailed Description

Oral lichen planus (OLP) is a T-cell mediated chronic immunological disease directed to a still unknown antigen. It is a mucocutaneous and a psychosomatic disorder, with unknown prevalence rate; however studies suggest an incidence of 0.02 to 0.22% among the Indian population. 75% of patients with cutaneous lichen planus also experience oral lesions and may be precipitated or exacerbated by psychosocial stressors.

In conditions like pain, anxiety and stress, many metabolic and endocrine changes occur in the body, the most common effect of which is increased cortisol level in blood. This hormone is a 21-carbon corticosteroid secreted by adrenal cortex and regulates the metabolism of carbohydrates, fats, proteins and water. Also known as stress hormone, cortisol is a decisive index in stressful situations.

This study is intended to correlate the serum cortisol levels with anxiety and depression in patients with symptomatic oral lichen planus.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500060
      • Panineeya Institute of Dental Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• Clinical features with burning sensation on eating spicy food.
• Patients with symptomatic Oral lichen planus evaluated clinically and histologically.

Exclusion criteria:

• Patients not willing to be part of the study.
• Patients who are on corticosteroid therapy.
• Patients with endocrinal disorders which can alter adrenal gland function.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: GROUP A; 5 ml of venous blood will be obtained from this group who do not have oral lichen planus and suffering from anxiety and/or depression. They will be administered a HADS standard questionnaire and their stress related issues calculated accordingly. This group has 30 patients totally	Procedure: venepuncture; for both the groups, HADS questionnaire will be administered to assess the levels of anxiety and depression. The placebo group ( group A) will not be having subjects suffering from oral lichen planus
Other: GROUP B; The group has 30 oral symptomatic lichen planus diagnosed patients also suffering with anxiety and/or depression. 5 ml of venous blood will be obtained from them for serum cortisol level analysis. HADS questionnaire will be administered for this group for evaluation of levels of anxiety and depression	Procedure: venepuncture; for both the groups, HADS questionnaire will be administered to assess the levels of anxiety and depression. The placebo group ( group A) will not be having subjects suffering from oral lichen planus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum- cortisol levels from venous blood.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Hospital Anxiety and Depression scale	1 year

Collaborators and Investigators

• Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Investigators: Principal Investigator: NALLAN chaitanya, MDS, Reader

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: January 4, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus
• Other Study ID Numbers: PMVIDS&RC/IEC/OMR/DN/0004-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No