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Effect of parent oriented educational mobile messages in pre-schoolers with tooth decay.

Completed
Conditions
Dental caries on pit and fissure surface,
Registration Number
CTRI/2023/03/050519
Lead Sponsor
Anu Sara Varghese
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 streptococc*i 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
100
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.To assess and compare the ‘chance of avoiding new cavities’ using Cariogram software for conventional and interventional groups.baseline, 4 months
2.To assess the contribution of the various risk factors in Cariogram software for conventional and interventional groupsbaseline, 4 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

St. Bridgets kindergarten school

🇮🇳

Belgaum, KARNATAKA, India

St. Bridgets kindergarten school
🇮🇳Belgaum, KARNATAKA, India
Sr M Jisha OS
Principal investigator
8792014576
bridgetbelgaum@gmail.com

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