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CTRI Number  CTRI/2018/02/011759 [Registered on: 07/02/2018] Trial Registered Retrospectively
Last Modified On: 09/02/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Checking the effect of "lycopene supplement" when consumed orally after non-surgical gum therapy. 
Scientific Title of Study   Evaluation of systemic Lycopene supplement as an adjunct to non-surgical periodontal therapy - a case-control, 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 Ravi Prabhu 
Designation  Post graduate student 
Affiliation  MGV KBH DENAL COLLEGE 
Address  room number 202, department of periodontology and implantology, MGVs KBH dental college and Hospital, panchavati, Nashik
43, PRABHU NIVAS SANSARI LANE
Nashik
MAHARASHTRA
422003
India 
Phone  9923012840  
Fax    
Email  ravimprabhu90@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amit Agrawal 
Designation  Professor 
Affiliation  MGV KBH DENAL COLLEGE 
Address  room number 202, department of periodontology and implantology, MGVs KBH dental college and Hospital, panchavati, Nashik
Panchavati, Nashik
Nashik
MAHARASHTRA
422003
India 
Phone    
Fax    
Email  agrodent@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amit Agrawal 
Designation  Professor 
Affiliation  MGV KBH DENAL COLLEGE 
Address  room number 202, department of periodontology and implantology, MGVs KBH dental college and Hospital, panchavati, Nashik
Panchavati, Nashik
Nanded
MAHARASHTRA
422003
India 
Phone    
Fax    
Email  agrodent@rediffmail.com  
 
Source of Monetary or Material Support  
room number 202, department of periodontology and implantology, MGVs KBH dental college and Hospital, panchavati, Nashik 
 
Primary Sponsor  
Name  none 
Address  none 
Type of Sponsor  Other [] 
 
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 
Dr Ravi Prabhu  Department of Periodontology and Implantology  MGVs KBH Dental College and Hospital, Panchavati, Nashik.
Nashik
MAHARASHTRA 
9923012840
9923012840
ravimprabhu90@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee Mahatma Gandhi Vidyamandirs KBH Dental College and Hospital, Nashik  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients advised non-surgical periodontal therapy.,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Lycopene Supplement  After sacling and root planing lycopene supplement in the form of capsule of 8 mg will be given orally for 14 days. After that clinical parameters will be checked. 
Comparator Agent  Scaling and root planing alone  After scaling and root planing only clinical parameters will be checked. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  . Systemically healthy patients.
2. Presence of at least 20 teeth in the mouth.
 
 
ExclusionCriteria 
Details  1. History of previous periodontal therapy.
2. Tobacco consumption in any form.
3. Use of antibiotics/ antioxidants in last 3 months.
4. Allergy to any content of the test drug.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
When lycopene given as supplement after scaling and root planing, it will show better healing.  Clinical parameters will be checked at baseline, 1 month and 3 months after research. 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/06/2016 
Date of Study Completion (India) 31/12/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The role of dietary antioxidant in disease prevention has received much attention in recent years. Diet rich in antioxidant are found to be anti –inflammatory. As suggested previously, the boosting of antioxidant micronutrient status of chronic periodontitis patient may have adjunctive therapeutic benefits.

Several studies have demonstrated that patients with periodontitis have significantly lower serum antioxidant levels compared to healthy controls.

Nonsurgical periodontal therapy by itself can reverse this trend and partly restore antioxidant levels but the therapy by alone may not have the desired benefits. It has been suggested that phyto-nutritional intervention in the form of antioxidant supplementation may have a beneficial effects through direct scavenging of reactive oxygen species (ROS)

The reactive oxygen species is mainly measured indirectly as the free radicals are so reactive and short lived that direct measurement is usually not possible.

Thus ROS is measured from the oxidative by-products of lipids proteins and nucleic acids. Uric acid as an end product of purine metabolism, is the most important endogenous antioxidant and acts as a potent free radical scavenger. Lycopene also acts as same. 

 
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