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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  
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 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  
Status 
Not Applicable 
 
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  
Outcome  TimePoints 
NA  NA 
 
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.

 
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