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
|
|
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
|
|
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 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. |