| CTRI Number |
CTRI/2020/09/028023 [Registered on: 24/09/2020] Trial Registered Prospectively |
| Last Modified On: |
23/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Conventional and Game-based Teaching on Oral
Health Status of Children |
|
Scientific Title of Study
|
Comparison of Conventional Versus Game-based Oral Health Education Methods in Oral Health-related knowledge and Oral Hygiene Status: A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinay S |
| Designation |
Professor |
| Affiliation |
Kalinga Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry,
Kalinga Institute of Dental Sciences,
KIIT University, Campus – 5,
Patia, Bhubaneswar – 751024,
Odisha.
Khordha
ORISSA
751024
India |
| Phone |
8763799695 |
| Fax |
|
| Email |
reachvnys@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay S |
| Designation |
Professor |
| Affiliation |
Kalinga Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry,
Kalinga Institute of Dental Sciences,
KIIT University, Campus – 5,
Patia, Bhubaneswar – 751024,
Odisha.
Khordha
ORISSA
751024
India |
| Phone |
8763799695 |
| Fax |
|
| Email |
reachvnys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinay S |
| Designation |
Professor |
| Affiliation |
Kalinga Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry,
Kalinga Institute of Dental Sciences,
KIIT University, Campus – 5,
Patia, Bhubaneswar – 751024,
Odisha.
Khordha
ORISSA
751024
India |
| Phone |
8763799695 |
| Fax |
|
| Email |
reachvnys@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Dental Sciences, Department of Public Health Dentistry, KIIT Deemed to be University, Campus-5, Patia, Bhubaneswar-751024, Odisha. |
|
|
Primary Sponsor
|
| Name |
Dr Vinay S |
| Address |
Department of Public Health Dentistry,
Kalinga Institute of Dental Sciences,
KIIT Deemed to be University,
Patia, Bhubaneswar, odisha |
| 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 |
| Sukhadev Samal |
Patani Samanta Primary School |
Chandaka Industrial Estate, Prasanti Vihar, Patia, Odisha, Bhubaneswar, Bhubaneshwar - 751024
School Code: 21171300184
Block: Bhubaneswar Municipality - Ward No 01
Rural/Urban: Urban
School Category: Primary with U.Primary
School Management: Private Unaided
School Type: Co-educational
Khordha
ORISSA |
9438568207
sukadevsamal81794@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Health Education Method |
Frequency: Weekly
Total Duration: 3 Months
Oral health instruction sessions done every week through conventional methods of oral health talks and posters only. |
| Intervention |
Game-Based Oral Health Education Method |
Frequency: Weekly
Total Duration: 3 Months
Oral health instruction sessions done every week through game based teaching method (snake and ladder, puzzles and dot-joining games) combined with flash cards educating the importance of maintaining good oral hygiene. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children between the age group of 7-10 years.
Children with parental consent for participation.
|
|
| ExclusionCriteria |
| Details |
Children with orthodontic or Prosthodontic appliances.
Children under antibiotic coverage for any reason in the past 3 weeks. |
|
|
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. Oral Hygiene Index (Simplified). |
At baseline,1 week, 1 month and 3 month intervals. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of their knowledge regarding oral health knowledge |
At Baseline and the end of 3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
25/09/2020 |
| 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="5"
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)?
|
|
Brief Summary
|
Need for the Study: Health education of school
children is an important part of prevention of oral health problems. School age
is the formative period physically as well as mentally, transforming the
school-child into a promising adult. Health habits formed at this stage will be
carried to adult age, old age, and even to next generation. The process of learning for
children should be through integration of education and entertainment, which
can be done by using various cost-effective media and materials. Game based
teaching is an educational strategy that facilitates and reinforcing child’s
learning in a thought-provoking and self-motivating format. Materials & Methods: The study will be conducted in the Patani Samanta Primary
School located in Prashanti Vihar, Patia, Bhubaneswar. The school has a total
of 256 children amongst which 134 students comprise the 7-10 years old age
group. A total of 100 students (7-10 yrs) will be randomly divided for the
study into two groups using computer generated random-allocation software. A trained interviewer will assess the childrens’ baseline
level of knowledge regarding oral hygiene. The questions will be read out and
also explained in the local language to eliminate bias. The questionnaire
consisted of demographic data and 11 questions regarding oral health, brushing
and diet. Randomization pattern will be obtained through computer
generated software based on which the students will be divided into two groups: Group A-Oral health instruction through presentation or
chalk and board only. Group B- Oral health instruction through presentation, game
based teaching method (snake and ladder, puzzles and dot-joining games)
combined with flash cards. The intervention will be started after a pre-test evaluation
of their knowledge regarding oral health knowledge using the questionnaire and baseline
debris & calculus assessment will be carried out using the Oral Hygiene
Index (Simplified). The two groups received oral health education using their
respective method. Oral health education will be reinforced one every week at
the school.
Post-intervention
assessment will be carried out at 1 week, 1 month and 3 month intervals.
|