| CTRI Number |
CTRI/2025/01/079583 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Uses of New Braille Tooth Story on Dental fear in blind Children |
|
Scientific Title of Study
|
Impact of Innovative Braille Tooth Tales on Dental Anxiety in Visually Impaired Children – A Randomised Control Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kashyap B |
| Designation |
Student |
| Affiliation |
AME Dental College, Raichur |
| Address |
Balkattu, moodubage, Ampar post, Kundapur taluk, udupi district- 576211
Udupi
KARNATAKA
576211
India |
| Phone |
9481682945 |
| Fax |
|
| Email |
kashyapkannanth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kashyap B |
| Designation |
Student |
| Affiliation |
AME Dental college , Raichur |
| Address |
Balkattu, moodubage, Ampar post, Kundapur taluk, udupi district- 576211
Udupi
KARNATAKA
576211
India |
| Phone |
9481682945 |
| Fax |
|
| Email |
kashyapkannanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Raghavendra Havale |
| Designation |
Professor And Head of The Department |
| Affiliation |
AME Dental College, Raichur |
| Address |
AME Dental College, Bijangera road, Raichur
Raichur
KARNATAKA
584103
India |
| Phone |
9448407300 |
| Fax |
|
| Email |
raghavendrahavale@gmail.com |
|
|
Source of Monetary or Material Support
|
| AME Dental college, Bijangera road, Raichur, Karnataka state, India- 584103 |
|
|
Primary Sponsor
|
| Name |
DR KASHYAP B |
| Address |
AME Dental College Raichur
Bijangera road
Raichur 584103 |
| 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 |
| DR KASHYAP B |
AME DENTAL COLLEGE RAICHUR |
Room number 4
AME DENTAL COLLEGE RAICHUR
Bijangera road
Raichur 584103
Raichur
KARNATAKA |
9113985663
kashyapbalkattu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for AME denatl college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Basic behavior modifications techniques are used for 1 week, later the anxiety scores are recorded and compared to braille e tooth tales |
| Intervention |
Innovative Braille tooth tales |
Braille story book is provided for 1 week, later the behavior modifications and anxiety are recorded and compared with tell feel do |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All visually impaired children between ages 6 and 12 years, with dental caries and calculus |
|
| ExclusionCriteria |
| Details |
Kids having other medical health related issues. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the impact on Braille tooth tales on blind children |
preoperative and
postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the impact on Braille tooth tales on dental anxiety in blind children |
preoperative and
postoperative |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/01/2025 |
| Date of Study Completion (India) |
02/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
02/04/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Aim To evaluate the impact of innovative braille tooth tales on visually impaired children.
Methodology Patients that come under inclusion criteria are allotted to the groups. Then
samples are subjected to Coin toss randomization based on the order
of the study. The study sample, examiner and analyzer are blinded.First visit of the study consists of oral examination of visually impaired children and base data recording while second visit consists of treatment which include restoration and oral prophylaxis and then the postoperative data is recorded. |