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
|
|
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
|
|
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. |