| CTRI Number |
CTRI/2024/03/063651 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A look into the efficacy of different types of visual mediums that can be used for the improvement of knowledge and awareness among the institutionalized hearing and speech impaired children in Bhubaneswar City, a randomized controlled trial. |
|
Scientific Title of Study
|
A Prod into the Efficacy of Visual Medium in Enhancing Oral Health Behaviour among Aural & Verbally Challenged Children via a RCT, in Bhubaneswar city, Odisha |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
N Sweta Abhaya Laxmi |
| Designation |
Intern |
| Affiliation |
Kalinga Institute of Dental Sciences |
| Address |
Room No 8 Department of Public Health Dentistry, Kalinga Institute of Dental Sciences, Patia, KIIT-DU, Bhubaneswar, Odisha
Khordha
ORISSA
751024
India |
| Phone |
6371792214 |
| Fax |
|
| Email |
nabhayalaxmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
N Sweta Abhaya Laxmi |
| Designation |
Intern |
| Affiliation |
Kalinga Institute of Dental Sciences |
| Address |
Room No 8 Department of Public Health Dentistry, Kalinga Institute of Dental Sciences, Patia, KIIT-DU, Bhubaneswar, Odisha
Khordha
ORISSA
751024
India |
| Phone |
6371792214 |
| Fax |
|
| Email |
nabhayalaxmi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
N Sweta Abhaya Laxmi |
| Designation |
Intern |
| Affiliation |
Kalinga Institute of Dental Sciences |
| Address |
Kalinga Institute of Dental Sciences, Patia, KIIT-DU, Bhubaneswar, Odisha
Khordha
ORISSA
751024
India |
| Phone |
8455936399 |
| Fax |
|
| Email |
nabhayalaxmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute Of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
N Sweta Abhaya Laxmi |
| Address |
Kanan Vihar Phase II, Patia, Bhubaneswar |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 |
| N Sweta Abhaya Laxmi |
BBC Government Vocational Higher Secondary School for Hearing Impaired |
Unit 3,Bhubaneswar
Khordha
ORISSA |
6371792214
nabhayalaxmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| BBC GOVT VOCATIONAL TRAINING SCHOOL, BHUBANESWAR |
Approved |
| IEC, Kalinga Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
70 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Picture Book |
Picture book will include simple pictures and facts about teeth and their functions, the foods which are good and bad for oral health, balanced diet, Fone’s brushing technique, oral hygiene routine, some exercises and a self maintaining planner of their frequency of brushing.
The duration of the study will be 3 months. |
| Comparator Agent |
Video |
In the customized video, the contents which are present in the book will be explained with the help of sign language by a trained individual who is trained in sign language. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
hearing and speech impaired children
Patient acceptance/cooperation for oral examination
Parental compliance. |
|
| ExclusionCriteria |
| Details |
Concomitant medical conditions
Patient cooperation not attained
Parental consent not obtained |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To encompass proper knowledge regarding oral health maintenance among the hearing and speech impaired children.
2.To educate the children regarding proper brushing technique using different visual aids (picture book , video)
3.To compare the oral hygiene among hearing and speech impaired children of 6-12 years old in two groups . |
Baseline data will be taken which will include self designed format that will include personal details such as name, age, gender which will be provided to the students to fill out , assessing their daily oral hygiene practice. Followed by the intervention for the two groups.
Periodic reinforcement of oral health education will be given at 1 week,4 week and 8 week interval. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To help every school child appreciate the importance of a healthy mouth and relationship of dental health to general health and appearance.
To encourage the observance of dental health practices, including personal care, professional care, proper diet, and oral habits.
To enlist the aid of all groups and agencies interested in the promotion of school health.
To correlate dental health activities with the total school health program.
To stimulate the development of resources to make dental care available to al children and youth. |
Baseline data will be taken which will include self designed format that will include personal details such as name, age, gender which will be provided to the students to fill out , assessing their daily oral hygiene practice. Followed by the intervention for the two groups.
Periodic reinforcement of oral health education will be given at 1 week,4 week and 8 week interval. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
14/03/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A Prod into the Efficacy of Visual Medium in Enhancing Oral Health Behaviour among Aural & Verbally Challenged Children via a RCT, in Bhubaneswar city, Odisha Need for the Study :Dental care is the most unmet health care need of the disabled children. It is observed that these children relatively have poorer oral hygiene and increased prevalence of gingival diseases and dental caries due to lack of proper brushing techniques and habits.
Aim/s of the Study: A Prod into the efficacy of visual mediums in Enhancing Oral Health Behaviour in Aural and Verbally Challenged Institutionalised Children of 6-12 years old in Bhubaneswar City, Odisha. | Objective/s of the Study: 1. To encompass proper knowledge regarding oral health maintenance among the hearing and speech impaired children. 2. To educate the children regarding proper brushing technique using different visual aids (picture book , video & sign language) 3. To compare the oral hygiene among hearing and speech impaired children of 6-12 years old in two groups .
|
Materials & Methods A double blinded, randomized clinical trial will be carried out on 70 hearing and speech impaired school children of 6–12 years in Bhubaneswar City, Odisha. Permission will be obtained from the institution for hearing and speech impaired children. The study procedure will consist of a baseline data, interventions, one reinforcement for allocated groups, and follow up examinations after 3 months. Children will be selected by the probability simple random sampling method and will be divided into three groups. Study design and its purpose will be explained to the school authorities, and former consent will be procured by the parents/guardians of the children from the school for deaf and mute. An interactive session will be conducted at the beginning of the study, in order to create a good rapport and understanding with the children. Documentation will be done using a self designed format that will include personal details such as name, age, gender and questionnaire which will be given to the institutionalized students to fill out. Before the start of the study, baseline data of Plaque index and Oral Hygiene Index-Simplified will be recorded for Groups I and II . Two individuals who will be trained and calibrated before beginning the study to eliminate inter examiner and intra examiner bias, will perform the interview and clinical oral examination. Individually, each participant will be explained about maintenance of good oral hygiene, curbing sweets intake to not more than three times/day, the role of fluoride in prevention of dental caries, Fone’s brushing technique, and to brush their teeth twice daily through booklet, sign language video and manualism. Caretakers will be advised and instructed to make a check on all the participants of their daily brushing frequency. The brushing technique and proper maintenance of oral hygiene will be explained to the teachers so that they could include a session in their daily classes (until the time of the intervention). Group I (Picture book) will be given a book on oral health which will include the simple pictures and facts about teeth and their functions, the foods which are good and bad for oral health,balanced diet,Fone’s brushing technique,oral hygiene routine,some exercises and a self maintaining planner of their frequency of brushing. The book will be printed in Odia language for the convenience of the students. For Group II( video group), the contents which are present in the book will be explained with the help of sign language by a trained individual who is trained in sign language. Oral hygiene will be assessed using Plaque index and Oral Hygiene Index-Simplified. | Sample size determination: Determination of sample size is done by G Power Software. 11.1 Sample Size: 70 | 11.2 Source of Data : BBC GOVT VOCATIONAL HSS FOR THE HEARING IMPAIRED. Unit -3, BBSR -22 | 11.3 Inclusion & Exclusion Criteria: Inclusion- hearing and speech impaired children Patient acceptance/cooperation for oral examination Parental compliance. Exclusion- Concomitant medical conditions Patient cooperation not attained Parental consent not obtained | 6.4 Method of Collection of Data (Including sampling Procedure, if any): Baseline data will be taken which will include self designed format that will include personal details such as name, age, gender which will be provided to the students to fill out , assessing their daily oral hygiene practice. Followed by the intervention for the two groups. After 15 days follow up will be done and then after 2months final analysis of the data will be done. |
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