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CTRI Number  CTRI/2021/10/037522 [Registered on: 25/10/2021] Trial Registered Prospectively
Last Modified On: 21/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Evaluating and Comparing the levels of MBL in normal and periodontitis affected patients. 
Scientific Title of Study   Evaluation and comparison of Mannose-binding lectin (MBL) in serum of Periodontally Healthy and Diseased subjects and its response to nonsurgical periodontal treatment: A clinico- biochemical study”. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dipika Mitra 
Designation  Professor and Head of the department of Periodontology 
Affiliation  Terna Dental College 
Address  Department of periodontology, department no.101,Plot no-12,Terna Campus RD,opposite to Nerul West Railway Station,Nerul West Sector-22,Nerul,NaviMumbai

Mumbai
MAHARASHTRA
400706
India 
Phone  9820180406  
Fax    
Email  drdipikamitra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrDipika Mitra 
Designation  Professor and Head of the department of Periodontology 
Affiliation  Terna Dental College 
Address  Department of periodonology ,department no.101,Plot no-12,Terna Campus RD,opposite to Nerul West Railway Station,Nerul West Sector-22,Nerul,NaviMumbai

Mumbai
MAHARASHTRA
400706
India 
Phone  9820180406  
Fax    
Email  drdipikamitra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivani Deviprasad Jaiswal 
Designation  Postgraduate student 
Affiliation  Terna Dental College 
Address  Department of periodontology, department no.101,Plot no-12,Terna Campus RD,opposite to Nerul West Railway Station,Nerul West Sector-22,Nerul,NaviMumbai

Mumbai
MAHARASHTRA
400706
India 
Phone  7020156042  
Fax    
Email  drjaiswalshivani@gmail.com  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  TPCTs Terna Dental College 
Address  Terna Dental College and Hospital, plot no.12,sector 22,opposite Nerul west railway station, Navi Mumbai, Maharashtra.  
Type of Sponsor  Other [private dental college] 
 
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 
DrShivani Jaiswal  TPCTs Terna dental college and hospital  Department of periodontics ,room no. 103 .Terna dental college and hospital ,plot no.12 , sector 22 , opposite nerul west railway station ,navimumbai , maharashtra
Mumbai
MAHARASHTRA 		 7020156042

drjaiswalshivani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Terna Dental College Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systemically healthy patients with healthy periodontium and patients with chronic periodontitis  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Scaling and root planing Oral hygiene instructions  All patients with chronic periodontitist will be treated with scaling and root planing in a single sitting followed by oral hygiene instructions. Patient will be recalled after 4 weeks to evaluate the serum MBL levels 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects between the age group of 18 – 60 years.
2. Subjects who have not received periodontal therapy, in the previous
six months.
3.Subjects who readily give informed consent for the study.
4. Systemically healthy patients.
 
 
ExclusionCriteria 
Details  1.Consumption of tobacco in any form and alcoholics.
2.Pregnant and lactating females.
3. Subjects who have received anti-inflammatory, antibiotic and
steroid drugs in previous three months.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To determine the levels of MBL in serum of periodontally healthy patients.
2.To determine the levels of MBL in serum of chronic periodontitis patients.
3. To compare levels of MBL in serum of periodontally healthy and chronic
periodontitis patients.
4.To correlate the effect of scaling and root planing on the levels of MBL in serum
of chronic periodontitis patients.
 		 Baseline
4 weeks after scaling and root planing 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate improvement in plaque index
,gingival index,pocket probing depth and clinical
attachment level in patients with chronic
periodontitis 4 weeks after scaling and root
planing. 		 plaque index ,gingival index,pocket probing
depth and clinical attachment level in patients
with chronic periodontitis will be taken at
baseline and then 4 weeks after scaling and root
planing. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/11/2021 
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="1"
Months="2"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a clinico-biochemical interventional study to compare the levels of MBL in periodontally healthy, patients with chronic periodontitis and its response to scaling and root planing. 
Study design:Group I (Periodontally Healthy) consisting of 25 subjects with clinically healthy periodontium and no evidence of disease (GI = 0; PPD ≤3 mm, CAL =0). • Group II (Chronic periodontitis) consisting of 25 subjects with chronic periodontitis (GI ≥1; PPD >3 mm, CAL >1mm). The subjects of group II will undergo scaling and root planing and will be re-evaluated after 4 weeks to re-determine the level of MBL.
Blood Collection: A 10 ml of blood will be obtained from the peripheral vein of 50 individuals. • At baseline: 10 ml of Blood samples to be collected from peripheral vein of individuals from group 1 and group 2 by trained personnel. Group 2 individuals will be subjected to non-surgical periodontal treatment and blood sample will be taken again after 1 month. The blood will be stored at 4°C, until analysis. The Mannose binding levels in serum samples will be measured by ELISA, using commercial kits according to the manufacturers’ guidelines. 
The data obtained will be entered into Microsoft excel spread sheet and will be further analyzed with the help of SPSS software (version 17.0, IBM, USA).


 
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