| CTRI Number |
CTRI/2023/07/054946 [Registered on: 07/07/2023] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of type of diet on periodontal health |
|
Scientific Title of Study
|
Comparative evaluation of effect of type of diet on periodontal health - A cross sectional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PothiReddy Rohith Kumar Reddy |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Dental Sciences Manipal Karnataka |
| Address |
Room No.3, Department of Periodontology, MCODS, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8686003985 |
| Fax |
|
| Email |
rohithkumarreddydhruva@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Lakshmi P |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences Manipal Karnataka |
| Address |
Room No 3, Department of Periodontology, MCODS, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9895318015 |
| Fax |
|
| Email |
lakshmi.puzhankara@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Lakshmi P |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences Manipal Karnataka |
| Address |
Room No 3, Department of Periodontology, MCODS, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9895318015 |
| Fax |
|
| Email |
lakshmi.puzhankara@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room No.3, Department of Periodontology, Manipal College Of Dental Sciences, Manipal,
Manipal Academy Of Higher Education, Udupi 576104 Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr PothiReddy Rohith Kumar Reddy |
| Address |
Room No 3, Department of Periodontology, Manipal College Of Dental Sciences, Manipal
576104 |
| 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 |
| Dr Rohith Kumar Reddy PothiReddy |
Manipal college of dental sciences , Manipal |
Room no.3, Dept of periodontology, Manipal college of dental sciences, Manipal 576104 Udupi KARNATAKA |
8686003985
rohithkumarreddydhruva@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College And Kasturba Hospital Institutional Ethics Committee -2 ( Student Research ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with age group from 18 to 70 years who visit the Department of periodontology ,MCODS,Manipal |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with atleast 20 teeth.
2. Subjects consuming a particular diet type for a period of minimum of 1 year.
3. Age > 18 years to 70 years |
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. Subjects with medical disorders undergoing antibiotic or other anti-microbial therapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Periodontal screening & recording
2. Oral hygiene index
3. DMFT
4. Bleeding Index |
Baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="240" Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "240"
Final Enrollment numbers achieved (India)="240" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/07/2023 |
| Date of Study Completion (India) |
19/12/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Periodontal inflammation is multifactorial in origin and is
considered to be one of the most important global oral health burdens. The
bacterial biofilm is the primary etiologic agent for periodontal disease. The
biofilm that accumulates on tooth surfaces can penetrate deep in to the
connective tissue and initiates host responses. The immune response to
microbial insult depend on various factors such as the patient’s immunity,
microbial colonization and presence of systemic diseases. The diet plays a
significant role in immune response both directly and indirectly which can
affect the periodontium. The micro and macro nutrients affect the inflammatory
process and anti-oxidant and oxidant balance. Vegetarians consume a higher
amount of antioxidants in form of fruits and vegetables. Antioxidants like
vitamin C has a central role in defending from free radicals, improve
chemotaxis and phagocytosis of polymorphonuclear leukocytes and improve
lymphocyte responsiveness.
Different types of diet
have been defined and the primary diet types include omnivorous, carnivorous,
pollotarian, pescetarian, vegetarian, and vegan. The definitions of the
different eaters are as follows: Omnivores is a person who eats all types of
food; A carnivore is a person who predominantly eats red meat, which includes:
pork, beef, veal and lamb; A pollotarian is a person who primarily eats poultry
instead of red meat; A pescetarian is a person who primarily eats fish and
seafood, as well as vegetables and other non-animal meat foods; A vegetarian is
a person who does not eat any type of meat and eats a plant-based diet instead;
A vegan is a person who does not eat any animal products or by-products and
strictly adheres to a plant-based diet.
Very few studies had
conducted in comparing periodontal health
and association with diet. Americans who ate a diet rich in meat and fried
foods had increased risk for periodontitis in a secondary analysis of NHANES
III data, which may have been attributed to the greater lipid deposition and
higher levels of systemic circulatory inflammatory molecules. Low meat and
fat diets may be associated with decreased production of reactive oxygen
species, reduced oxidative damage of mitochondrial DNA, lower cytokine
production ,and improved metabolic parameters such as blood glucose and insulin
sensitivity, which maybe protective against periodontitis. In many cases
vegetarian diets are helpful in the prevention and treatment of certain
diseases like hypertension, diabetes, dementia, cardiovascular diseases and
even gall stone and rheumatoid arthritis.
In 2021, Pew Research Center released the results of a survey
throughout India which included questions on dietary preferences. According to
this study, around 39% of the overall Indian population identifies as vegetarian.Since the majority of the population are consumers of diet that cannot be
described as vegetarian, it is imperative that the effect of the different
types of diet as well as dietary components on periodontium is identified and
appropriate diet counselling may be performed. |