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CTRI Number  CTRI/2023/03/050519 [Registered on: 09/03/2023] Trial Registered Prospectively
Last Modified On: 13/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of parent oriented educational mobile messages in pre-schoolers with tooth decay. 
Scientific Title of Study   Cariogram-based comparison of caries risk profile in pre-schoolers before and after giving parent oriented educational mobile messages in Belagavi city - An interventional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anu Sara Varghese 
Designation  Postgraduate student 
Affiliation  KAHER’s KLE Vishwanath Katti Institute of Dental Sciences 
Address  Department number 2, Public Health Dentistry, ground Floor, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9901193736  
Fax    
Email  anusv1995@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anu Sara Varghese 
Designation  Postgraduate student 
Affiliation  KAHER’s KLE Vishwanath Katti Institute of Dental Sciences 
Address  Department number 2, Public Health Dentistry, ground Floor, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar


KARNATAKA
590010
India 
Phone  9901193736  
Fax    
Email  anusv1995@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Roopali Sankeshwari 
Designation  Professor 
Affiliation  KAHER’s KLE Vishwanath Katti Institute of Dental Sciences 
Address  Department number 2, Public Health Dentistry, ground Floor, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9844837197  
Fax    
Email  docrups@gmail.com  
 
Source of Monetary or Material Support  
KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, 590010, Karnataka, India 
 
Primary Sponsor  
Name  Anu Sara Varghese 
Address  Department number 2,Public Health Dentistry, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, 590010, Karnataka, India 
Type of Sponsor  Other [self funded] 
 
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 
Sr M Jisha OS  St. Bridgets kindergarten school  Nursery classroom, Ground floor, St. Bridgets kindergarten school, Vaibhav Nagar, Bauxite Road, Nehru Nagar P.O Belgaum 590010 KARNATAKA
Belgaum
KARNATAKA 
8792014576

bridgetbelgaum@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee KLE VKIDS  Approved 
St. Bridgets kindergarten schoo  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional Oral Health education  conventional oral health education will be given to the mothers at Baseline. Reassessment will be done after 4 months using Cariogram. 
Intervention  Parent oriented educational messages   Parent oriented educational messages will be sent fortnightly for 4 months after which reassessment will be done using cariogram. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1.Children aged 3-6 years attending preschools
2.Parents who accept to participate in all stages of research by signing a written informed
consent form.
3.Parents who already have WhatsApp Messenger application installed on their smartphones,
or those who agree to install it for participating in the study.
4.Parents who can read and understand English language 
 
ExclusionCriteria 
Details  1.Children who are severely ill, or with any systemic disease
2.Children having zero caries experience.
3.Children having severe caries experience (DMFT>7)
4.Parents who do not use smart phone 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To assess and compare the ‘chance of avoiding new cavities’ using Cariogram software for conventional and interventional groups.
2.To assess the contribution of the various risk factors in Cariogram software for conventional and interventional groups  
baseline, 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/03/2023 
Date of Study Completion (India) 26/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   NEED FOR THE STUDY 
Dental caries is a universally prevalent chronic disease and around 520 million children suffer from caries of the primary teeth globally. Parents play an important role in filtering the interaction between children and their environment through the feeding habits, oral hygiene care and other preventive practices and services. Thus it is imperative that parents be given appropriate dental health education. In oral health education, there is always a need to reinforce concepts beyond the clinical encounter. The evidence suggests that the use of application and text messages is ideal for repetition and reinforcement. The impact of educational mobile phone text messaging must be assessed by a valid and reliable tool. Since there are multiple caries risk factors which may vary from person to person, Cariogram seems to be the best tool. It is a computerized program that considers the interaction of different caries risk factors, chiefly biological factors such as past caries experience, related diseases, diet contents & frequency, plaque amount, Mutans streptococci count, fluoride program, saliva secretion & buffer capacity. Cariogram also assesses the risk for new carious lesion development and graphically presents the caries risk profile of an individual.
Existing deficiencies of current literature
Text-message-based mobile health (mHealth) interventions have the potential to significantly improve the self-management of noncommunicable diseases such as diabetes, hypertension, and obesity. These strategies are at an infancy stage of research regarding oral health. Moreover, there is a lack of clinical trials testing specific interventions to the management of caries and its risk factors in children. Therefore, the present study aims to assess and compare the effectiveness of parent oriented educational mobile messages and conventional oral health education in the caries risk profile among pre-schoolers using Cariogram. 

OBJECTIVES
1.To assess and compare the ‘chance of avoiding new cavities’ at baseline and post intervention using Cariogram software. 
2.Assessment of the contribution of the various risk factors in Cariogram software for both the groups at baseline and post intervention.

RESEARCH HYPOTHESIS: 
There is a difference in the impact of conventional oral health education and parent oriented educational mobile messaging in the caries risk profile of pre-school children.

METHODOLOGY:
 
Study Design : Single blind, parallel arm, Randomized controlled field trial 
Study population: Children of age group 3-6 years and their parents will be randomly selected from  preschools of Belagavi city. 
Sample size estimation: Sample size estimation was done based on erstwhile data procured from a former study by M.Nishi et al., 95% confidence interval; 80% power  n= 43.45 per group Considering 10% drop-out rate n= 47.8 rounding up to 50 per group Estimated total sample size is 100 
Sampling technique:
Two stage random sampling technique will be used. 
A list of all  preschools of Belagavi city will be obtained from the Women and Child development officer.
 In the first phase,4 schools will be randomly selected. 
 In the second phase, all children in the age group of 3-6 years from the selected schools will be screened for inclusion and exclusion criteria, and 100 children will be randomly selected. 

Study interventions:
All children from the selected preschools will be screened for inclusion and exclusion criteria.
One hundred children will be selected randomly.
Baseline assessment
    Clinical examination followed by saliva collection will be done
         Distribution of proforma to the parents
         All the data will be entered into the Cariogram software.
         Oral health education will be given in conventional method to all the parents.
         Randomization will be done using computer generated table of random numbers
     Parent oriented educational messages will be sent fortnightly for 4 months to the intervention group
     Post intervention assessment after 4 months.
         Details will be entered into Cariogram software
         A caries risk summary sheet will be given to both groups

STATISTICAL ANALYSIS

Descriptive statistics will be calculated for the frequency distribution, mean and standard deviation.

Paired T tests/ Wilcoxon signed rank test will be applied to test significance before and after intervention. Consecutively unpaired T test/ Mann Whitney U test will be used for intergroup comparison.

Pearson/Spearman correlation tests will be applied to test correlation between factors in the Cariogram and the chance of avoiding cavities.

EXPECTED OUTCOMES:
Improvement in oral hygiene of children which will be evident clinically with reduced oral hygiene index scores. Improvement in the oral health knowledge of parents after 4 months.
 Reduction in the caries risk of children which will be evident from ‘chance to avoid new cavities’ in the cariogram software.
 Reduction in sugar consumption of children.
 Improved salivary flow in children with  reduction in level of Streptococcans mutans and Lactobacillus colony count.
 
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