A clinical trial to compare the levels of sclerostin and ICTP in periodontitis patients
- Conditions
- Chronic periodontitis, ,
- Registration Number
- CTRI/2020/12/029657
- Lead Sponsor
- Rajarajeswari Dental College and Hospital
- Brief Summary
Periodontal disease is a complex biological process related to the interaction between groups of microorganisms and the host immune/inflammatory response. The periodontal tissue destruction is driven by oral microbial flora that colonize the subgingival area and causes local and systemic diseases. Immune responses gets activated on stimulation by bacteria or their products present in the dental bioï¬lm and eventually play a major role in the alveolar bone breakdown observed in periodontitis.Sclerostin (SOST) is a secreted glycoprotein and an important regulator of WNT (Wingless-related integration site) signaling in bone metabolism.The regulation of bone metabolism is a complex process of different signal transduction pathways depending on several local and systemic factors including cytokines, chemokines, hormones, and biochemical stimulation.SOST is primarily expressed by osteocytes and binds to lipoprotein receptorâ€related protein (LRP) 5/6 on the osteoblasts. Its expression is regulated by cytokines, mechanosensors and endocrine factors.Sclerostin deficiency leads to sclerosteosis and Van Buchem disease, characterized by progressive bone thickening due to increased bone formation.Inflammatory osteoclastogenesis mediated by pro-inflammatory mediators characterizes the central pathologic process of periodontitis.ICTP, a 12–20kDa fragment of type I collagen of bone, is released after bone resorption or collagen matrix degradation.Following procollagen synthesis and its release into the maturing extracellular matrix, collagen fibrils undergo post-translational modification resulting in cross-links between the telopeptide regions of type I collagen chains by lysyl oxidase.These cross-links are essential for providing mechanical stability to the maturing matrix and are specific to bone and cartilage and are not found in soft tissues such as skin where the cross-link is initiated by histidine residues.Elevated ICTP during bone resorptive events has also been found to coincide with the resorption rate as measured by histomorphometry and calcium kinetics.ICTP has recently been shown to highly correlate with high/low bone turnover diseases (myxedema, thyrotoxicosis, and primary hyperparathyroidism) as well as post-menopausal osteoporosis.ICTP correlated strongly with radiographic bone level and pocket depth and was significantly higher at periodontitis sites compared to non periodontitis sites.Hence the aim of the present study is to evaluate the levels of Sclerostin and C- telopeptide pyridinoline cross links (ICTP) in GCF and serum of gingivitis and stage II to stage III periodontitis patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 45
- Adult males and females who were diagnosed with healthy,gingivitis and stage II to stage III periodontitis patients.
- Group 1 : Healthy controls 1.
- No sites with probing depth ≥4mm or clinical attachment loss ≥1mm.
- 2 .Patient who do not show any gingival disease with a gingival index score <1.
- Group 2 : Gingivitis 1.
- No sites with probing depth ≥3mm.
- Clinical attachment loss <3mm.
- Patient who exhibited > 20 sites with BOP.
- Patient who show gingival disease with a gingival index score >1.
- Group 3 : Stage II to Stage III Periodontitis.
- Clinical attachment loss ≥ 5mm.
- Radiographic evidence of alveolar bone loss extending to middle third of root and beyond.
- Tooth loss ≤ 4 teeth.
- Probing depths≥ 6mm.
- Patients with history of systemic diseases.
- Smokers and alcoholic patients.
- Patients on any medication taken within 6 months which may alter the clinical parameters of the study.
- Pregnant and lactating women.
- Patients who have undergone periodontal treatment within a period of last 1 year.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Gingival index (GI) (Loe H and Silness - 1963). At baseline •Probing pocket depth (PPD) measured using graduated Williams periodontal probe from the crest of gingival margin to base of the pocket. At baseline •Periodontal index (PI) (Russell -1956). At baseline
- Secondary Outcome Measures
Name Time Method •Gingival index (GI) (Loe H and Silness - 1963). •Probing pocket depth (PPD) measured using graduated Williams periodontal probe from the crest of gingival margin to base of the pocket.
Trial Locations
- Locations (1)
Rajarajeswari Dental Collge and Hospital
🇮🇳Bangalore, KARNATAKA, India
Rajarajeswari Dental Collge and Hospital🇮🇳Bangalore, KARNATAKA, IndiaAsha VPrincipal investigator9108572447ashavijayanand3011@gmail.com