| CTRI Number |
CTRI/2020/10/028670 [Registered on: 27/10/2020] Trial Registered Prospectively |
| Last Modified On: |
10/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The advantage of lycopene capsule over cleaning and polishing in smokers having gum problems |
|
Scientific Title of Study
|
Effect of systemic Lycopene therapy as an adjunct to scaling and root planing in smokers with chronic periodontitisâ€: a randomized controlled clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJustina David Joy |
| Designation |
Post graduate student |
| Affiliation |
Yenepoya Dental College |
| Address |
Dept.of Periodontology, Yenepoya dental college , deralakatte, Mangalore, 575018
Dept.of Periodontology, Yenepoya dental college , deralakatte, Mangalore, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8113820865 |
| Fax |
|
| Email |
justinadavidjoy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinita Boloor |
| Designation |
Reader |
| Affiliation |
Yenepoya Dental College |
| Address |
Dept.of Periodontology, Yenepoya dental college,
Deralakatte,Mangalore
575018.
Dept.of Periodontology, Yenepoya dental college,
Deralakatte,Mangalore
575018.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845114652 |
| Fax |
|
| Email |
drvinitaboloor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinita Boloor |
| Designation |
Reader |
| Affiliation |
Yenepoya Dental College |
| Address |
Dept.of Periodontology, Yenepoya dental college,
Deralakatte,Mangalore
575018.
Dept.of Periodontology, Yenepoya dental college,
Deralakatte,Mangalore
575018.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845114652 |
| Fax |
|
| Email |
drvinitaboloor@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Justina David Joy |
| Address |
Dept of Periodontology
Yenepoya Denatl College
Deralakatte
Mangalore
575018 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Justina David Joy |
Yenepoya Dental College |
Room No :7 Dept of periodontology college,
deralakatte
managlore
575018
Dakshina Kannada
KARNATAKA |
8113820865
justinadavidjoy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YENEPOYA ETHICS COMMITTEE 2 |
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 |
Health vit lycopene with scaling and root planing |
Lycopene are the carotenoid compounds which are responsible for the yellow, red and
orange pigments and are synthesized in plants. They are abundantly found in tomatoes
and have been linked to oxidation preventing mechanisms. The developing degenerative diseases such as asthma, cancer ,cardiovascular diseases,, stroke, arthritis, hepatitis and
also periodontitis caused by free radicals has shown a reduction with the consumption of
lycopene.Lycopene has also been used in the treatment of other oral disease such as
oral cancer, oral leukoplakia, oral submucous fibrosis etc.
It is considered as the most effective antioxidant agent because of its uncommon feature
of binding to chemical species that react to oxygen and when compared to the other
carotenoids lycopene has relatively higher antioxidant capacity. |
| Comparator Agent |
Scaling an root planning |
Is the process by which residual embedded calculus and portions of cementum are removed from the roots to produce a smooth, hard and clean surface and is the conventional periodontal therapy. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
-The subjects should be systemically healthy.
-Age group : 25 to 64 years
-Probing depth ≥ 4mm
-Minimum of 14 teeth should be present.
-Gender : males and females
-Current smokers will be selected (CDC guidelines)
-Subjects who give an informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
-Allergic to lycopene or to any of its food sources, especially tomatoes.
-Pregnant and lactating women.
-Patients undergone periodontal therapy in past 6 months.
-Patients under antibiotic/anti-inflammatory drugs.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess salivary total antioxidant capacity induced by lycopene on periodontal parameters (Plaque index ,Gingival index ,Probing pocket depth ,Clinical attachment level). |
baseline, 15th day, 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the salivary total antioxidant capacity in smokers with periodontits undergoing scaling and root planing alone and undergoing scaling and root planing with systemic administration of lycopene. |
baseline, 15th day, 30th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/11/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable study not started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is being conducted to assess the salivary total antioxidant capacity in smokers with periodontitis before and after treatment with systemic administration of lycopene. In normal physiology there is a dynamic equilibrium between the reactive oxygen species (ROS) and antioxidants which is shifted if there is a decrease in the antioxidant release or increase in ROS leading to oxidative stress. ROS if produced in high amounts is capable enough to cause periodontal tissue destruction by acting directly or indirectly on tissue and cause damage which is neutralized by the antioxidants. Thus antioxidants play a major role in the protection of normal health of periodontium. Smoking plays an important role in the pathogenesis of periodontal diseases by increasing the oxidative stress, causing imbalance between oxidative stress and antioxidant capacity and dysregulation of innate and adaptive immune system. Lycopene are the carotenoid which are responsible for the yellow , red and orange pigments and are synthesized in plants and have been linked to oxidation preventing mechanisms. The developing degenerative diseases such as asthma, cancer, cardiovascular diseases, stroke, arthritis, hepatitis and also periodontitis caused by free radicals has shown a reduction with the consumption of lycopene. It is considered as the most effective antioxidant agent because of its uncommon feature of binding to chemical species that react to oxygen. Studies have also shown that lycopene is a promising treatment modality as an adjunct to scaling and root planing in chronic periodontitis patients. |