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CTRI Number  CTRI/2020/12/029657 [Registered on: 09/12/2020] Trial Registered Prospectively
Last Modified On: 27/11/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized Factorial Trial 
Public Title of Study   A clinical trial to compare the levels of sclerostin and ICTP in periodontitis patients 
Scientific Title of Study   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: A COMPARATIVE ANALYTICAL STUDY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ASHA V 
Designation  Post Graduate 
Affiliation  Rajarajeswari DentalCollege and hospital 
Address  No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074 Rajarajeswari Dental College and hospital

Bangalore
KARNATAKA
563126
India 
Phone  9108572447  
Fax    
Email  ashavijayanand3011@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Savita 
Designation  Head of the Department of Periodontology 
Affiliation  Rajarajeswari Dental College and hospital 
Address  Rajarajeswari Dental College and hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka 560074
Rajarajeswari Dental College and hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka 560074
Bangalore
KARNATAKA
560074
India 
Phone  9845446437  
Fax    
Email  dr.s.savita@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ASHA V 
Designation  Post Graduate 
Affiliation  Rajarajeswari DentalCollege and hospital 
Address  No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074 Rajarajeswari Dental College and hospital

Bangalore
KARNATAKA
563126
India 
Phone  9108572447  
Fax    
Email  ashavijayanand3011@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari Dental College and hospital 
 
Primary Sponsor  
Name  Rajarajeswari Dental College and Hospital 
Address  No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka 560074 Rajarajeswari Dental College and hospital 
Type of Sponsor  Other [Private Dental college and Hospital] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Asha V  Rajarajeswari Dental Collge and Hospital  No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074 Rajarajeswari Dental Collge and Hospital
Bangalore
KARNATAKA 
9108572447

ashavijayanand3011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical committee of Rajarajeswari Dental College & Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis, ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Evaluating serum and GCF levels of sclerostin and C-TELOPEPTIDE PYRIDINOLINE CROSS LINKS molecules  Collection of GCF and serum in healthy, gingivitis and periodontitis patients to evaluate the levels of sclerostin and C telopeptide pyridinoline crosslinks using ELISA kit. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  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.
2. Clinical attachment loss <3mm.
3. Patient who exhibited > 20 sites with BOP.
4. Patient who show gingival disease with a gingival index score >1.

Group 3 : Stage II to Stage III Periodontitis.
1. Clinical attachment loss ≥ 5mm.
2. Radiographic evidence of alveolar bone loss extending to middle third of root and beyond.
3. Tooth loss ≤ 4 teeth.
4. Probing depths≥ 6mm.
 
 
ExclusionCriteria 
Details  1. Patients with history of systemic diseases.
2. Smokers and alcoholic patients.
3. Patients on any medication taken within 6 months which may alter the clinical parameters of the study.
4. Pregnant and lactating women.
5. Patients who have undergone periodontal treatment within a period of last 1 year.

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
•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.
•Periodontal index (PI) (Russell -1956).
 
At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
•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.
•Periodontal index (PI) (Russell -1956).
 
At baseline 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/12/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet done 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 biofilm 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 receptor‐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.

 
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