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CTRI Number  CTRI/2017/11/010611 [Registered on: 23/11/2017] Trial Registered Prospectively
Last Modified On: 22/11/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Prevalence and effectiveness of a oral health program on caries risk among children 
Scientific Title of Study   Prevalence of dental caries risk and effect of a multi component oral health program on caries risk among anganwadi children from Thiruvananthapuram  
Trial Acronym  EMCOHPCR 
Secondary IDs if Any  
Secondary ID  Identifier 
SBMR 27717/2016/MCT  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NAMITHA P 
Designation  Rsearch Scholar 
Affiliation  Medical College, Thiruvananthapuram 
Address  Govt Medical College Thiruvananthapuram Kerala

Thiruvananthapuram
KERALA
695011
India 
Phone  7025696977  
Fax    
Email  namitha.syam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Premaletha T 
Designation  Associate Professor 
Affiliation  Govt College of Nursing 
Address  P G Block Govt College of Nursing Medical College Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9446122388  
Fax    
Email  premalethaaradhana@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrPremalethaT 
Designation  Associate Professor 
Affiliation  Govt College of Nursing 
Address  Govt College of Nursing Medical College Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9446122388  
Fax    
Email  premalethaaradhana@gmail.com  
 
Source of Monetary or Material Support  
Investigator initiated trial Namitha P Thripthi Varinjam Aduthala P O Kollam Kerala Pin 691579  
 
Primary Sponsor  
Name  Namitha P 
Address  THRIPTHY VARINJAM ADUTHALA KOLLAM KERALA 
Type of Sponsor  Other [investigator initiated trial] 
 
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 
Namitha P  Govt.Medical College  Medical College P O Thiruvananthapuram
Thiruvananthapuram
KERALA 
7025696977
9446122388
namitha.syam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee Medical College Thiruvanathapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  caries risk children  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  caries risk children  caries risk children who are not restricted from regular dental hygienic practices 
Intervention  Multi component oral health program   Multi component oral health program includes an application of fluoride varnish to the caries risk children and an education program for the mothers of caries risk children 
 
Inclusion Criteria  
Age From  3.00 Day(s)
Age To  5.00 Day(s)
Gender  Both 
Details  1st phase

1 Children between 3-5 yrs from Anganwadies of Thiruvananthapuram district.
2 Children, whose parents give permission to participate their children in the study.
3 Children who are present during the data collection.

2nd phase

1 Children with caries risk, between 3 and 5yrs from Anganwadies of Thiruvananthapuram district.
2 Mothers of caries risk children who are willing to participate in the study.
 
 
ExclusionCriteria 
Details  1st phase

- Children less than 3 and above 5yrs enrolled in the Anganwadies of Thiruvananthapuram district.
- Children, whose parents are not willing to participate their children in the study
- Children who are absent during the data collection.
- Children who are not cooperative during data collection.

2nd phase

- Children who are having systemic or developmental disorders.
- Children who are undergoing any orthodontic treatment
- Children whose mothers are absent during data collection.
- Mothers and teachers of caries risk children who are not willing to participate in the study.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in the caries risk in terms of reduction in the dmft and ICDAS score while comparing experimental group with the control group.   1year 
 
Secondary Outcome  
Outcome  TimePoints 
The knowledge of mothers on oral health and prevention of dental caries will improve after the Oral health program  1 month 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   15/12/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Dental caries is the most common infectious disease affecting human. This dental disease is preventable and yet continues to be a major public health problem predominantly affecting children. According to the National Oral Health Survey recently conducted throughout India, dental caries was seen in 51.9% of 5yrs old children. The survey recommended a preventive dental health program such as use of fluoride tooth paste; water fluoridation should be initiated to address the problem of dental caries.9

Children have 20 primary teeth, which often erupt about 6months of age and usually when child is 2.5-3yrs old, all primary teeth are found in the mouth. By 6yrs of age, many children are getting their first adult molars. Primary teeth have function other than biting and chewing. They help to provide nutrition, aid in the normal development of the jaw bones and facial muscles, give face its normal appearances, make speech possible, reserve space for the permanent teeth and help to guide them into position.10

One of the most important functions of primary teeth is reserving space for the permanent teeth and help to guide them into position. So it is very important to maintain the health of the primary teeth. Neglected cavities can lead to problems which affect developing permanent teeth. Primary teeth also affect the development of speech and add to an attractive appearance. While the front four teeth last until 6-7 yrs of age, the back teeth (cuspids and molars) are not replaced until age 10-13. 11 As a permanent tooth is ready to erupt, the root of the primary tooth begins to dissolve. The permanent tooth pushes the primary tooth that has been resorbing for it. If a primary tooth is lost too soon, the permanent tooth has no guide to follow. Also the teeth next to a missing tooth may drift into the space left by the missing tooth. In this situation dentist may provide the child with a space maintainer. But it is preferable to take early preventive measures to prevent early tooth loss. So child can keep all primary teeth until they are ready to be shed.

One of the latest research done in Malappuram, Kerala revealed that the prevalence of dental caries was seen more in children studying in government schools than in private schools which was statistically significant (P=0.018). There was no significant difference seen in the prevalence of calculus between government and private school children. High prevalence of dental caries was found in these school children who suggested a poor performance of oral hygiene practices in them.12

A study done on early childhood caries lesions in preschool children in Kerala, India emphasized that the groups at high risk from dental caries lesions are, those who consume snacks and are given sweets as rewards and those belonging to a lower socio economic class. This study also showed that the majority of caregivers (79%) knew about the causes of dental caries lesions and 85% of them knew ways to prevent caries lesions but 59% were not sure whether primary teeth needed to be restored. There was no necessity for a dental check up for children before the age of 1 yr according to 19% of the care givers, and 76% indicated that they would visit the dentist only if a dental problem arose.13

Dental caries, also known as tooth decay, cavities or caries is a breakdown of teeth due to activities of bacteria14. The cavities may be in different colors from yellow to black. Symptoms may include pain and difficulty with eating. Complications may include inflammation of the tissue around the tooth, tooth loss and infection or abscess formation15,16.

Dental caries in the primary dentition has received renewed attention in recent years because caries in the primary dentition is predictive of later caries experience. A study done by Warren et all on dental caries in the primary dentition and assessing prevalence of cavitated and noncavitated lesions revealed that the decay experience was most common on the primary second molars. About 56% of untreated decay was located in the pits and fissures, while 58 percent of decay was located on smooth surfaces.17

Many countries have developed different strategies to reduce or even eradicate dental caries from preschool children following dental caries surveys. Most of them have already obtained excellent results using water and salt fluoridation, dental health education, school oral health program and so forth. The results of a recent research done in Palestine shown that 76% of the studied children have already experienced dental caries at the age of 4-5 yrs (1046 children). There is a real need to make improvements at the level of parent’s dental health education, application of preventive measures and dietary habits among preschool children.18

A cross- sectional study to determine prevalence of early childhood caries among preschool children in Trivandrum depicted that relatively high dental caries prevalence rate of 54%. The study done on 1329 preschool children of less than 60 months of age randomly selected from rural and urban areas of Trivandrum. This study   also showed a positive association between early childhood caries and age of child, location of residence, dietary habits and oral hygiene habits.19

Early childhood caries (ECC) is considered as a serious public health problem as it is a complex disease of primary dentition which relay serious socio-behavioral issues that afflict mainly the infants and toddlers. Early Childhood Caries, if untreated the deleterious effect are pain, compromised chewing ability, malocclusion, phonetic problem, suboptimal health, lower self esteem. ECC is social, political, behavioral, medical, psychological, economical and dental problems that affect the quality of life. 20

Caries is also associated with poverty, poor cleaning of the mouth. Word wide approximately 2.43 billion people (36% of the population) have dental caries in their permanent teeth. The WHO estimates that nearly all adults have dental caries at some point in time. In baby teeth it affects about 620million people or 9% of the population. They have become more common in both children and adults in recent years.21

A person experiencing caries may not be aware of the disease. The earliest sign of a carious lesion is the appearance of a chalky white spot on the surface of the tooth, indicating an area of demineralization of enamel. This is referred to a white spot lesion or a microcavity.22 As the lesion continues to de mineralize, it can turn brown but will eventually turn into cavitation (cavity). Before the cavity forms, the lost tooth structure can be regenerated. Dental caries can also cause bad breath and foul tastes. In highly progressed cases, infection can spread from the tooth to the surrounding soft tissues. Complications such as cavernous sinus thrombosis and Ludwig angina can be life threatening.23

Poor oral health can have a detrimental effect on children’s performance in school and their success in later life. Children who suffer from poor oral health are 12 times more likely to have more restricted activity days including missing school than those who do not. More than 50 million hours annually are lost from school due to oral diseases. It has been hypothesized that oral health can be improved through health education, schools provide an ideal setting for promoting oral health, it offers an efficient and effective way to reach over 1 billion children worldwide, and through them, families and community members.24 A recent study done in Chennai revealed that oral health education is effective in improving oral health status of school children; data shows that oral hygiene is improved by decrease in plaque and gingival bleeding and also there was a significant decrease in dental caries.25

A study to evaluate the effect of a school-based oral health education in preventing untreated dental caries and increasing knowledge, attitude practice among adolescent, done in Bangladesh projected out, there was a significant improvement in school aged adolescents’ self reported  knowledge, attitude and practices scores. The prevalence of untreated dental caries of the study population after the Oral Health Education program was significantly reduced to 42.5% from 76.6%.  26

Oral health education is most widely used in prevention of dental diseases. A systematic review done to evaluate the effectiveness of oral health education among school children in Chennai revealed that it is highly effective in improving oral health in school children. Six studies were included in the review. Four studies provided data for comparison of plaque and gingival index scores and two studies provided data comparison of DMFT index scores. Results showed interventions were effective in reducing the dental plaque, improving gingival status and decreasing DMFT scores of the children.27

              A subsequent randomized trial which provided an intensive preventive regimen involving interactive counseling, intensive oral hygienic intervention, fluoride lozenges, xylitol lozenges, fluoride varnish, chlorhexidine varnish and distribution of tooth paste containing 1,500 ppm fluoride and 10% xylotol to high risk Finnish children aged 11-12 yrs, found a 44% reduction in caries in the intervention group compared to the control group.29

Early childhood caries is one of the most prevalent chronic diseases of children that affect their life and their family in different aspects. Using different types of fluoride is one of the most effective ways for preventing the disease. Fluoride varnish is a topical fluoride product which could use in the community even by non-professional. A study aimed to assess the effect of fluoride varnish on dental caries in a group of children aged 3-6 years old in Kerman kindergarten during 6 month’s period. This community interventional study recruited a sample of volunteer children from 12 kindergartens through a cluster sampling. Kindergarten randomly allocated to test and control group after matching. Dental examination was performed in three phases of the study by a trained dentist using criteria of Intentional Caries Detection and Assessment System. Fluoride varnish was applied for test group in the first phase after dental examination and also 3 and 6 months after this phase. Control group has received varnish product just after 3 and 6 months after the first dental exam. The results revealed that the mean dmft of the participants in the first stage of the study was 5.08 and decreased to 4.77 in the third stage. Results of this study also prove those the preventive effect of fluoride varnish on dental caries. Even though this study was a short-term one, a reduction in caries is evident; therefore we are hopeful that the continued use of varnish in kindergarten will help to promote oral health of children.30

The investigator during her school and community visits has come across that the preschool children lack proper oral care and are more prone to develop dental caries. The investigator also noticed that there is no specific preventive program for dental caries in our country. Many studies proved that the dental caries can be prevented by the proper utilization of oral health programs. These factors motivated the investigator to determine the effect of a multi-component oral health program on caries risk among children from Anganwadies, Thiruvananthapuram district.

Aims and objectives

The aim of the study is to determine the prevalence and effect of multi component oral health program on   Caries risk among children from Anganwadies Thiruvananthapuram   district.

         Phase-I

         Primary Objectives

-    Find out the prevalence of caries risk among Anganwadi children from Thiruvananthapuram   district by American Academy of Pediatric Dentistry (AAPD) Caries risk tool and Salivary mutants strip test.

         Secondary Objectives

-    Find the association between caries risks and selected demographic variables of the Anganwadi children from Thiruvananthapuram.

 

 Phase-II

        Primary Objectives

-    Determine the effect of a multi component oral health program on caries risk among children from Anganwadies, Thiruvananthapuram interms of dmft index and ICDAS (International Caries Detection and Assessment System).

Secondary objectives

-    Identify the effect of a planned teaching program on knowledge of mothers regarding Oral health and Prevention of Dental caries. 

 
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