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CTRI Number  CTRI/2022/07/044266 [Registered on: 22/07/2022] Trial Registered Prospectively
Last Modified On: 16/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparison of salivary visfatin and serum lipid levels in obese chronic periodontitis patients before and after non surgical periodontal therapy 
Scientific Title of Study   Effect of non-surgical periodontal therapy on salivary visfatin and serum lipid levels in obese patients with chronic periodontitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aishwarya Polumatla  
Designation  Postgraduate student 
Affiliation  Sibar Institute of Dental Sciences 
Address  Room no -8, Department of periodontology, Sibar institute of dental sciences, Takellapadu, Guntur.

Guntur
ANDHRA PRADESH
522509
India 
Phone  9959232998  
Fax    
Email  aishwarya.polumatla@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DRLAXMI TEJASWINP 
Designation  Reader 
Affiliation  Sibar Institute of Dental Sciences 
Address  Room no -8, Department of periodontology, Sibar institute of dental sciences, Takellapadu, Guntur.

Guntur
ANDHRA PRADESH
522509
India 
Phone  9849854819  
Fax    
Email  tejaswinpolepalle@gmail.com  
 
Details of Contact Person
Public Query  
Name  DRLAXMI TEJASWINP 
Designation  Reader 
Affiliation  Sibar Institute of Dental Sciences 
Address  Room no -8, Department of periodontology, Sibar institute of dental sciences, Takellapadu, Guntur.

Guntur
ANDHRA PRADESH
522509
India 
Phone  9849854819  
Fax    
Email  tejaswinpolepalle@gmail.com  
 
Source of Monetary or Material Support  
Elabscience,14780 Memorial Drive, Suite 216, Houston, Texas 77079.  
 
Primary Sponsor  
Name  Aishwarya polumatla 
Address  room no 8, Dept of periodontology, Sibar institute of dental sciences, takellapadu, Guntur. 
Type of Sponsor  Other [self] 
 
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 
Aishwarya Polumatla  Sibar Institute of Dental Sciences  Room no -8, Department of periodontology,
Guntur
ANDHRA PRADESH 		 9959232998

aishwarya.polumatla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, Sibar institute of dental sciences.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z683||Body mass index (BMI) 30-39, adult, (2) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Non surgical Periodontal therapy  Non surgical periodontal therapy will be done in both arms as intervention to treat chronic periodontitis. 
Comparator Agent  salivary visfatin and serum lipid levels  salivary visfatin and serum lipid levels will be compared at baseline and 6 weeks post operatively 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details 
Patients with Chronic periodontitis. Patients with minimum of 20 teeth. 
 
ExclusionCriteria 
Details  Patients with history of cigarette smoking, alcohol intake and chewing tobacco habits.
Previous history of any periodontal treatment before 6 months.
Pregnancy and lactating women
Under any medication that affect the periodontal status and lipid profile.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease in salivary visfatin and serum lipid levels after non surgical periodontal therapy in chronic periodontitis.  At baseline and after 6 weeks of non surgical periodontal therapy. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/08/2022 
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="6"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aishwarya.polumatla@gmail.com].

  6. For how long will this data be available start date provided 01-03-2022 and end date provided 01-10-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A total of 40 patients will be selected according to the inclusion and exclusion criteria. A return informed consent will be obtained from all the patients. BMI scores will be recorded and based on the results the subjects are divided into obese  and non-obese groups . Both the groups are chronic periodontitis patients. Study aims in measuring the salivary visfatin and serum lipid levels before and after non surgical periodontal therapy in both the groups. At base line clinical parameters include GI,PPD & CAL, serum lipid levels will be measured and salivary visfatin levels will be taken after non surgical periodontal therapy after 6 weeks follow up all the clinical parameters will be re assessed to observe the changes in the salivary visfatin and serum lipid levels in both the subjects. 
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