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CTRI Number  CTRI/2021/06/033956 [Registered on: 02/06/2021] Trial Registered Prospectively
Last Modified On: 12/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Dentistry
Process of Care Changes
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Oral Health Education through mobile based application and personalised based story on 12 Year Old Children in Chennai city 
Scientific Title of Study   Effectiveness Of Mobile Application Based And Personalised Oral Health Education On Oral Hygiene Of 12 Year Old Children In Chennai 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  Canty Sandra S 
Designation  1st year post graduate 
Affiliation  Ragas Dental College and Hospital, Chennai . 
Address  Department OF Public Health Dentistry Ragas Dental College and Hospital 2 / 202 East Coast Road Uthandi Chennai - 600119 Tamilnadu

Chennai
TAMIL NADU
600119
India 
Phone  9629744131  
Fax    
Email  cantysandra95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr PD Madan kumar 
Designation  Professor and Head 
Affiliation  Ragas Dental College and Hospital, Chennai . 
Address  Department OF Public Health Dentistry Ragas Dental College and Hospital 2 / 202 East Coast Road Uthandi Chennai - 600119 Tamilnadu

Chennai
TAMIL NADU
600119
India 
Phone  9790291104  
Fax    
Email  christynimmys@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Canty Sandra S 
Designation  1st year post graduate 
Affiliation  Ragas Dental College and Hospital, Chennai . 
Address  Department OF Public Health Dentistry Ragas Dental College and Hospital 2 / 202 East Coast Road Uthandi Chennai - 600119 Tamilnadu

Chennai
TAMIL NADU
600119
India 
Phone  9629744131  
Fax    
Email  cantysandra95@gmail.com  
 
Source of Monetary or Material Support  
Self Ragas Dental College and Hospital 2 / 202 East Coast Road Uthandi Chennai - 600119 Tamilnadu  
 
Primary Sponsor  
Name  self 
Address  Ragas Dental College and Hospital 2 / 202 East Coast Road Uthandi Chennai - 600119 Tamilnadu  
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 
CANTY SANDRA S  ST Joseph Higher Secondary School  Kovalam , Thiruporur , Kancheepuram - 603112
Kancheepuram
TAMIL NADU 
9629744131

cantysandra95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
THE INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ORAL HYGIENE 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mobile Application based Oral Health Education  Mobile application based oral health education (Toothbrush Guide App - Brush monster- kitten planet). For 3 months given daily. 
Comparator Agent  Not applicable  Not applicable 
Intervention  Personalised Oral Health Education  Personalised oral health education (custom made - story).For 3 months given daily. 
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Subjects who are 12 years old.
2. Subjects owning smart mobile phones
3. Subjects whose parents give consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Subjects whose parents did not give consent to participate in the study
2. Subjects with physical and cognitive disabilities who will not be suitable for viewing and hearing this video are excluded in this study.
3. Subjects who have any acute dental problems at the time of examination which requires immediate attention.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Oral Hygiene  3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   14/06/2021 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Oral health describes the well-being of the oral cavity, including the dentition and its supporting structures and tissues. The most commonly prevalent oral disease in children is the dental caries and gingivitis. Globally it is estimated that more than 530 million children suffer from caries of primary teeth. A continued high intake of free sugars, inadequate exposure to fluoride and a lack of removal of plaque by toothbrushing can result in poor oral health. Oral hygiene maintenance is crucial for prevention of various oral diseases. The different strategies of oral health education constitute an essential tool in promotion and prevention, because they encourage and motivate individuals to take responsibility for their own health. Behavioral interventions or education to the individual about how to maintain the pleasant condition of a person’s mouth are required to reduce the oral health problems and to promote oral health . Learning about oral health traditionally has been depended on traditional techniques. The traditional methods used at present are demonstration of correct brushing technique through models , pamplets , videos and by verbal based oral health education. Oral health education through traditional lecturing has been found successful in improving oral health knowledge. As an innovative idea to attract children we can convey oral health education to the children in the form of stories ( personalised ) to make them learn the proper brushing technique as well as for habit formation . As technology advances at an ever-rapid speed, there are revolutionary ways to learn proper tooth brushing and habit formation. A number of technologies, techniques and methodologies are available in this context. Mobile application based oral health education is the current trend which can be scientifically referred as augmented reality. These applications use real-time  information in the form of text, graphics, audio, and other virtual enhancements integrated with real-world objects. Their main advantages include  interactive nature and its ability to differentiate between digital and real world of 3D modelling of anatomical structures and it enhances visual sense. In dentistry its used for education in oral and maxillofacial , implant and orthognathic surgeries . Nowadays everything is based upon smart phone applications . Current research suggests mobile technologies, such as smartphone applications are a cost-effective approach to provide health information to large populations.  The propagation of applications that leverage smartphone technology has increased along with the ubiquity of smartphone adoption. Learning and cultivation of appropriate healthy habits are usually encouraged in younger age group. The use of interactive teaching methods will help them to enhance the learning and performance. The importance of 12 year old age group are that it is the index group for assessment of school children as indicated by the World Health Organization. There is hardly any evidence on comparison of two interactive methods of oral health education for children. With this background, this study is formulated to assess the effectiveness of mobile application based and personalised oral health education on oral hygiene of 12 year old children .

 
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