| CTRI Number |
CTRI/2024/01/061710 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Social story on toothbrushing skills among special children |
|
Scientific Title of Study
|
Impact of social story intervention in training toothbrushing skills among specially abled children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aseema Samal |
| Designation |
Post Graduatee trainee, Dept of Public Health Dentistry |
| Affiliation |
Kalinga Institute of Dental Sciences |
| Address |
Room no-8 Dept of Public Health Dentistry, Kalinga Institute of Dental Sciences, KIIT University, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
8249944974 |
| Fax |
|
| Email |
draseemasamal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ipseeta Menon |
| Designation |
Professor and Head, Dept of Public Health Dentistry |
| Affiliation |
Kalinga Institute of Dental Sciences |
| Address |
Room-8, Dept of Public Health Dentistry, Kalinga Institute of Dental Sciences, KIIT University, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9811194629 |
| Fax |
|
| Email |
ipseetam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aseema Samal |
| Designation |
Post Graduatee trainee, Dept of Public Health Dentistry |
| Affiliation |
Kalinga Institute of Dental Sciences |
| Address |
Kalinga Institute of Dental Sciences, KIIT University, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
8249944974 |
| Fax |
|
| Email |
draseemasamal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kalinga Institute of Dental Sciences |
| Address |
Kalinga Institute of Dental Sciences, KIIT University |
| Type of Sponsor |
Other [Dental College] |
|
|
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 |
| Dr Aseema Samal |
Kalinga Institute of Dental Sciences |
Room No-8, Department of Public Health Dentistry
Khordha
ORISSA |
8249944974
draseemasamal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KALINGA INSTITUTE OF MEDICAL SCIENCES(KIMS), KIIT DEEMED TO BE UNIVERSITY, BHUBANESWAR, 751024 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, (2) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Social story intervention regarding toothbrushing skills |
The study will be conducted to access the tooth brushing performance and oral hygiene status among children with and without autism before and after using the social story intervention. The study population includes children having developmental disabilities between the age group 6-14 years. All the autistic and other developmental disorder children will be recruited from the institutionalized centres in Bhubaneswar and Cuttack. At first childrens’s oral hygiene status, gingival health status and the tooth brushing performance was recorded at the baseline. After which a social story intervention was provided to all participants. The whole tooth brushing procedure will be divided into 13 distinct steps and a validated social story will be employed to demonstrate these stories.
Follow up was done after 3 months and 6 months along with a reinforcement if needed.
At 6 month the final oral health status was assessed and compared with the baseline data. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children whose parents are willing to give consent to participate in the study.
Children who are mentally challenged including those having Autism spectrum Disorder, Attention Deficit Hyperactive Disorder, Cerebral palsy, Down syndrome etc |
|
| ExclusionCriteria |
| Details |
1. Children below 6 years age.
2. Children who are physically challenged. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the tooth brushing performance and oral hygiene status among children with and without autism before and after using the social story intervention.
|
Baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Specially abled children might become independent in doing their daily toothbrushing activity. |
0, 3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="178"
Sample Size from India="178"
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)
|
31/01/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be conducted to access the tooth brushing performance and oral hygiene status among children with and without autism before and after using the social story intervention. The study population includes children having developmental disabilities between the age group 6-14 years. All the autistic and other developmental disorder children will be recruited from the institutionalized centres in Bhubaneswar and Cuttack. At first childrens’s oral hygiene status, gingival health status and the tooth brushing performance was recorded at the baseline. After which a social story intervention was provided to all participants. The whole tooth brushing procedure will be divided into 13 distinct steps and a validated social story will be employed to demonstrate these stories. Follow up was done after 3 months and 6 months along with a reinforcement if needed. |