Download annexure ii - Rajiv Gandhi University of Health Sciences

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
Dr. MALADEVI M
Name of the Candidate
And
Permanent Address :
(BLOCK LETTERS)
97/102, KAMARAJAR STREET,
THENI DISTRICT,
TAMILNADU,
PIN-625531
DEPARTMENT
OF
PEDODONTICS
AND
PREVENTIVE
DENTISTRY,
1.
Local Address :
(BLOCK LETTERS)
M.S.RAMAIAH DENTAL COLLEGE & HOSPITAL,
M S RAMAIAH EDUCATIONAL CAMPUS,
M.S.R.NAGAR , M.S.R.I.T. POST ,
BANGALORE – 560054
Dr. MALADEVI M
M.D.S STUDENT,
DEPARTMENT
Address for correspondence
OF
PEDODONTICS
AND
PREVENTIVE
DENTISTRY,
M.S.RAMAIAH DENTAL COLLEGE & HOSPITAL,
BANGALORE-54
M.S.RAMAIAH
2. Name of the Institution
DENTAL
COLLEGE
AND
HOSPITAL,
BANGALORE.
MASTER OF DENTAL SURGERY(M.D.S.)
3. Course of Study and Subject
4.
PEDODONTICS AND PREVENTIVE DENTISTRY.
Date of Admission to the rd
3 June, 2013
Course
Title of the Topic:-
5.
INFANT FEEDING PRACTICES AS A RISK FACTOR FOR ECC IN 18-48 MONTH OLD
CHILDREN –A CASE CONTROL STUDY
6.
BRIEF RESUME OF THE INTENDED WORK
6.1 Need for the study
Early childhood caries (ECC) affects the teeth of infants and toddlers as soon as they
erupt1. A wider spectrum of information about feeding habits and sugar intake would
probably elucidate the factors promoting ECC2.
During early childhood, specific feeding patterns in young children were associated
with dental caries3. Since 2002 World Health Organisation and other associations have been
recommending exclusive breast feeding for 6 months followed by complementary feeding as
optimal infant feeding practice. However the 2008 commentary of the European Society for
Pediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition (ESPGHAN),
recommended that complementary foods should be introduced to infants between 17 and 26
weeks. The earlier introduction of complementary foods is further encouraged by labels of
most commercial product ‘suitable’ from 4 months4.
Hence, the current study is aimed to evaluate the complementary food introduction time
and pattern among children suffering from early childhood caries (ECC).
6.2 Review of literature
A cross sectional study was conducted on 1250 children of 3-5 years of age with early
childhood caries. Age of the child, number of siblings in the family, mother’s education and
dietary factors like sucrose exposure in between meals, sucrose exposure at meals, total
frequency of sucrose exposure and total sweet score were found to be significantly associated
with ECC. However non-significant association was observed with socio economic status1.
A cross sectional study was carried out among 504 children on four day period
regarding child’s dietary habits. The burden of milk bottle-feeding at night was a clear
determinant of ECC. Whereas prolonged breast feeding and day time sugar intake appears to
have no such negative dental consequences2.
A
prospective study was done to investigate the association between infant feeding
practices and development of Early Childhood caries among 315 children. Prolonged breast
feeding, bottle use for sweetened liquids other than milk and introduction of solid foods at six
months old or later were found to be associated with ECC5.
A randomised controlled trial was conducted to find the efficacy of healthy feeding
advices during the first year of life and occurrence of ECC and SECC at 4 years of age. The
study results showed that home nutritional advice during first year of life decreases the caries
incidence and severity in low income community6.
A cross sectional study comprising 1250 children aged 3 to 5 years was done to
investigate whether feeding and oral hygiene practices of preschool children were associated
with the risk and prevalence of ECC. Prolonged breast feeding, absence of burping the child,
delay in starting oral hygiene practices and lack of parental assistance with the same were
shown to be significant determinants of ECC7.
6.3 AIM & OBJECTIVES OF THE STUDY
Aim:

To determine whether the time of complementary food introduction and pattern are
associated as risk factors for ECC.
Objectives:
1. To examine and divide the children into two groups, one group with ECC and other
without ECC
2. To study the time of complementary food introduction and pattern between children.
3. To find the association between complementary feeding time and patterns between
these two groups.
7. MATERIALS AND METHODS
Study setting:
The school based study will be conducted among 18-48 months old children of play
schools, day care and Anganwadis of Bangalore North after obtaining an informed consent
from the parent/caregivers and permission from concerned school authorities. A
questionnaire will be given to the parents to study the feeding habit of the child.
Study Design:
The study design will be case control study
7.1METHOD OF COLLECTION OF DATA
Sample size and technique:
Tanaka et al has observed that the proportion of caries among children who were
introduced early complementary food was 19% and who were introduced complementary
food 6 months and after was 29%.
In the present study expecting similar results and to get a precision of 75% power, 5%
of significance and 95% confidence level, the sample size is been determined as 197 subjects
in each group.
Statistical Methods:
Descriptive statistics of proportion of caries will be analysed and present in terms of
percentage. Chi square test would be used to find the association between infant feeding
practices and ECC. Logistic regression would be used to find out independent risk factors for
ECC.
Inclusion criteria:

School Children of 18-48 months of age.

CASES- Children with deft score ≥1.

CONTROLS- Children with deft score ≤1.
Exclusion criteria:

Children with any syndromes or any other systemic diseases.

Uncooperative child who do not allow oral examination.
DEFINITION OF ECC:
The American Academy of Paediatric Dentistry defines early childhood caries as the
presence of one or more decayed (non-cavitated or cavitated),missing(as a result of caries ) or
filled tooth surfaces in any primary tooth in a child 71 months of age or younger.
Methodology:
The study will be undertaken in various steps as below.
Step 1: Sampling Frame determined
Children will be selected according to the inclusion criteria after obtaining informed
consent from the parent or caregiver and permission from concerned school authorities.
Step 2: Data collection

Oral examination will be done to determine deft score (WHO 1997 Oral Health
Survey criteria).

Questionnaire will be given to the parents to study the time of complementary food
introduction and pattern.
7.2 Does the study require any investigations or interventions to be conducted on
patients or other humans or animals? If so, specify briefly
Yes. The study requires the examination of oral cavity for presence of dental caries. A
questionnaire will be given to the parents to know the time when the complementary food
was introduced and other patterns of feeding. But no intervention will be carried out for
the same.
7.3 Has the ethical clearance been obtained from your institution in case of the above?
Yes, the ethical clearance has been obtained.
8.LIST OF REFERENCES
1. Sankeshwari RM, Ankola AV, Tangade PS, Hebbal I. Association of socioeconomic
status and dietary habits with early childhood caries among 3 to 5 year old children of
Belgaum city. Eur Arch Paediatr Dent 2013; 14:147-153.
2. Mohebbi SZ, Virtanen JI, Golpayegani Vahid M, Vehkalahti MM. Feeding habits as
determinants of early childhood caries in a population where prolonged breastfeeding
is the norm. Community Dent Oral Epidemiol 2008; 36:363-369.
3. Danaher Carol, Fredericks Doris, Bryson Susan, Agras Stewart, Ritchie Lorrene.
Early Childhood Feeding Practices Improved after Short-Term Pilot Intervention with
Pediatricians and Parents. Childhood Obesity. 2011; 7(6):480-487.
4. Cattaneo Adriano, Williams Carol, Carmen Rosa Pallas-Alonso, Maria Teresa
Hernandez
Aguilar,
Juan
Jose
Lasarte-Velillas
et
al.
ESPGHAN’S2008
recommendation for early introduction of complementary foods: how good is the
evidence?
Maternal & Child nutrition 2011; 7:335-343.
5. Tanaka Keiko, Miyake Yoshihiro, Sasaki Satoshi, Hirota Yoshio. Infant feeding
practices and risk of dental caries in Japan: The Osaka Maternal and child health
study. J Paediatric Dentistry 2013; 35(3): 267-271.
6. Feldens CA, Giugliani ERJ, Duncan BB, Vitolo MR. Long term effectiveness of a
nutritional program in reducing early childhood caries: a randomized trial. Community
Dent Oral Epidemiol 2010; 38:324-332.
7. SankeshwariRM, Ankola.AV, Tangade PS, Hebbal I. Feeding habits and oral hygiene
practices as determinants of early childhood caries in 3-5 year old children of
Belgaum city, India. Oral Health Prev Dent 2012; 10:283-290.
INFORMED CONSENT FORM (FOR PARENT/GUARDIAN)
TITLE: INFANT FEEDING PRACTICES AS A RISK FACTOR FOR ECC IN 18-48
MONTH OLD CHILDREN – A CASE CONTROL STUDY.
Information to the subjects:
We are conducting a school based study in the Department of Pedodontics and Preventive
Dentistry at M. S. Ramaiah Dental College. Early Childhood Caries is more common chronic
dental disease in children that is multifactorial in nature. We are conducting a study to find
the possible risk factors for the Early Childhood Caries. We request you to kindly consent to
participate in our study. If you consent, we will be, conducting oral examination of your
children to assess his/her caries status using a sterile wooden ice cream stick after air drying
using chip syringe. And a questionnaire will be given to you to study the feeding pattern of
your child. Please be informed that you have all the right not to consent and to withdraw your
consent during any part of the study. Your refusal or withdrawal from the study will not
adversely affect you in any way. With your co-operation in the study, you will be helping us
contribute to scientific knowledge.
Undertaking by the investigator:
Your consent to allow your child to participate in the above study is sought. You have the
right to refuse consent or withdraw the same during any part of the study without stating any
reason. We undertake to maintain complete confidentiality regarding the identity of the
subjects and the information obtained from the subjects during the course of the study. We
assure you that all the standard infection control precautions will be strictly adhered to
throughout the study. If you have any doubts regarding the study, please feel free to clarify
the same. Even during the study, you are free to contact any of the investigators for
clarification if you desire. The list of investigators and their contact numbers are below.
Dr.Maladevi M – 9901206302
Dr LathaAnandakrishna - 9845379751
PG Student
Professor and head of the department
Department of Pedodontics
Department of Pedodontics
and Preventive dentistry
and Preventive dentistry
INFORMED CONSENT FORM
“INFANT FEEDING PRACTICES AS A RISK FACTOR FOR ECC IN 18-48
MONTH OLD CHILDREN- A CASE CONTROL STUDY’
Chief Investigator: Dr. Maladevi M
Guide: Dr. Latha Anandakrishna
Name of the child:
Address:
Age:
Sex:
Name of Parent / Guardian:
Telephone no:
I _______________________ Parent / Guardian of _____________________aged ________
have been explained in understandable language by Dr. Maladevi M, about the nature of the
study to be conducted for my child that involves oral examination with sterile ice cream stick
followed by air drying with chip syringe, followed which a questionnaire will be given to the
parents to know about the feeding practices done during infancy. I understand that the
information gained will be kept confidential and will be used for academic purposes only. I
willingly consent to allow my child to be a part of the above mentioned study and I am aware
that I can withdraw at any point of time from the study with no retribution of any kind. I
hereby voluntarily give my consent and have no objection collection of information for the
study.
Signature of Doctor
Signature of Parent/ Guardian