TO ESTIMATE AND CORRELATE LEVELS OF GHRELIN AND LEPTIN IN GINGIVAL CREVICULAR FLUID OF HEALTH, CHRONIC GENERALIZED PERIODONTITIS OF PATIENTS WITH AND WITHOUT OBESITY – A CLINICO-BIOCHEMICAL STUDYâ€.
- Conditions
- Body mass index [BMI],
- Registration Number
- CTRI/2024/01/061099
- Lead Sponsor
- DR. G.NAGATULSI
- Brief Summary
Periodontitis is a chronic inflammatory condition caused by dental biofilms. Clinically this disease is characterized by periodontal pockets and loss of attachment ultimately leading to tooth loss1.
Ghrelin is a peptide hormone, predominantly secreted in the stomach and is also known as hunger hormone. Ghrelin demonstrates immunomodulatory properties of which the anti-inflammatory activity depends on the levels of acylation. This process occurs due to suppression of IL-8 production by TNF-α or lipopolysaccharide stimulated oral epithelial cells .1
Ghrelin also demonstrates inflammatory properties with low grade inflammation with higher acylated ghrelin levels being observed in chronic periodontitis patients.
Ghrelin interacts through endogenous ligand for the growth hormone secretagogue receptor (GHS-R) to specifically inhibit the expression of proinflammatory anorectic cytokines such as IL-1β, IL-6 and TNF-α.2
Leptin, a product of the obese gene, is a 16-kDa non-glycosylated peptide hormone. It is synthesized mainly in adipocytes, which regulate weight control and modulate other physiological functions, such as regulation of neuroendocrine and reproductive systems.
Leptin also stimulates the immune system by enhancing pro-inflammatory cytokine production and phagocytosis by macrophages3.
Ghrelin has shown dose dependent inhibition of leptin induced cytokine expression, while leptin upregulated GHS-R expression on human T-lymphocytes.
To our knowledge, no studies have correlated ghrelin, leptin and periodontal disease. Thus, our study aims to explore the relationship between ghrelin and leptin in periodontal health and disease in gingival crevicular fluid (GCF), whilst evaluating Body mass index (BMI) in obese patients.4
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 36
- ∙ Subjects of either sex, between the ages of 20 years and 60 years.
- ∙ Presence of at least 20 natural teeth.
- Subjects with normal lipid profile having BMI values as given by Asian Specific Perspective Obesity-WHO 2000.
- 1.BMI in range of 18.5-22.9 kg/m2 in non-obese Waist circumference (WC) men : WC≤ 90cm women : WC≤80cm 2.
- BMI in range of 25-29.9 kg/m2 in obese men : WC ≥90cm women : WC ≥80cm ∙ Patients with diagnosis of generalized stage III grade B periodontitis.
- (Periodontal health, gingivitis and periodontitis definition will be based on the classification of periodontal and peri-implant diseases and conditions as proposed in 2017 World Workshop).
- ∙ Individuals who have received periodontal therapy in the last 6 months.
- ∙ Individuals with systemic diseases other than type 2 diabetes mellitus (HbA1c < 7.0) ∙ Individuals who have history of antimicrobial and anti-inflammatory therapy in the past 6 months ∙ Pregnant/lactating and postmenopausal women.
- ∙ Smokers.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ∙ To estimate the levels of Ghrelin and leptin in GCF of subjects in health and chronic periodontitis with or without obesity at baseline. ∙ To estimate the levels of Ghrelin and leptin in GCF of subjects in health and chronic periodontitis with or without obesity AT THE BASELINE | ∙ To correlate the levels of Ghrelin and leptin in GCF of subjects in health and chronic periodontitis with or without obesity AT BASE LINE | ∙ To explore the possibility of using Ghrelin and leptin as a marker for inflammation in generalized stage III grade B periodontitis and relate them with clinical parameters AT BASE LINE. ∙ To correlate the levels of Ghrelin and leptin in GCF of subjects in health and chronic periodontitis with or without obesity at baseline. ∙ To estimate the levels of Ghrelin and leptin in GCF of subjects in health and chronic periodontitis with or without obesity AT THE BASELINE | ∙ To correlate the levels of Ghrelin and leptin in GCF of subjects in health and chronic periodontitis with or without obesity AT BASE LINE | ∙ To explore the possibility of using Ghrelin and leptin as a marker for inflammation in generalized stage III grade B periodontitis and relate them with clinical parameters AT BASE LINE. ∙ To explore the possibility of using Ghrelin and leptin as a marker for inflammation in generalized stage III grade B periodontitis and relate them with clinical parameters at baseline. ∙ To estimate the levels of Ghrelin and leptin in GCF of subjects in health and chronic periodontitis with or without obesity AT THE BASELINE | ∙ To correlate the levels of Ghrelin and leptin in GCF of subjects in health and chronic periodontitis with or without obesity AT BASE LINE | ∙ To explore the possibility of using Ghrelin and leptin as a marker for inflammation in generalized stage III grade B periodontitis and relate them with clinical parameters AT BASE LINE.
- Secondary Outcome Measures
Name Time Method Ghrelin and leptin Before treatment
Trial Locations
- Locations (1)
THE OXFORD DENATL COLLEGE
🇮🇳Bangalore, KARNATAKA, India
THE OXFORD DENATL COLLEGE🇮🇳Bangalore, KARNATAKA, IndiaDRGNAGATULSIPrincipal investigator9742420669tulsinaidu974242@gmail.com