| 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
|
|
|
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
|
|
|
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 . |