| CTRI Number |
CTRI/2024/10/076017 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effectiveness of an Oral Health Program on Improving Oral Hygiene Practices Among Visually Impaired Individuals in Lucknow |
|
Scientific Title of Study
|
Effect of customized oral health awareness program on knowledge and practice of oral hygiene maintenance among institutionalized visually impaired people of Lucknow city A prospective interventional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohit Kumar Kanoujia |
| Designation |
MDS second year |
| Affiliation |
King Georges Medical University |
| Address |
Old dental building, KGMU, second floor, department of public health dentistry
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7905815978 |
| Fax |
|
| Email |
kanoujiamohit1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Kumar |
| Designation |
Professor Junior Grade |
| Affiliation |
KGMU |
| Address |
Old dental building, KGMU, second floor, department of public health dentistry
UTTAR PRADESH
226003
India |
| Phone |
9411660202 |
| Fax |
|
| Email |
sumitpalsmile@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohit Kumar Kanoujia |
| Designation |
MDS Second year |
| Affiliation |
KGMU |
| Address |
Old dental building, KGMU, second floor, department of public health dentistry
UTTAR PRADESH
226003
India |
| Phone |
7905815978 |
| Fax |
|
| Email |
kanoujiamohit1@gmail.com |
|
|
Source of Monetary or Material Support
|
| King Georges Medical University, Shamina Road, chowk, Lucknow ,UP, 226003, India |
|
|
Primary Sponsor
|
| Name |
King Georges Medical University |
| Address |
OLD DENTAL BUILDING, KGMU, SECOND FLOOR, DEPARTMENT OF PUBLIC HEALTH DENTISTRY, SHAMINA ROAD,CHOWK,LUCKNOW,UP,226003, INDIA |
| Type of Sponsor |
Government medical 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 Mohit Kanoujia |
King Georges Medical University |
Old dental building, KGMU, second floor, department of public health dentistry
Lucknow
UTTAR PRADESH |
7905815978
kanoujiamohit1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University UP Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
VISUALLY IMPAIRED |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
oral health education |
audio only (baseline, 30 days, 90 days, 180 days)
frequency is 4 times and total duration is 180 days |
| Comparator Agent |
oral health education |
audio only (baseline, 30 days, 90 days, 180 days) frequency is 4 times and total duration is 180 days |
| Comparator Agent |
oral health education |
audio with braille (baseline, 30 days, 90 days, 180 days) frequency is 4 times and total duration is 180 days
|
| Intervention |
oral health education |
audio with braille (baseline, 30 days, 90 days, 180 days) frequency is 4 times and total duration is 180 days |
| Intervention |
oral health education |
audio with models (baseline, 30 days, 90 days, 180 days) frequency is 4 times and total duration is 180 days |
| Comparator Agent |
oral health education |
audio with models (baseline, 30 days, 90 days, 180 days) frequency is 4 times and total duration is 180 days |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
bilateral (total/partial) visual impairment,
compliance and cooperation of oral examination by patients,
parental/self acceptance |
|
| ExclusionCriteria |
| Details |
serious medical conditions requiring priority treatment,
patient/parents who do not cooperate.
patient/parent who do not provide informed consent. |
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visually impaired people encounter some challenges for their oral health. Using this study, we may be able to compare the effectiveness of oral health education using audio alone, audio with Braille and audio with art package (models) On oral health status of visually impaired people. |
baseline, 30 days, 90 days, 180 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes of the study include assessing long-term retention of oral health knowledge and improvements in oral hygiene practices among visually impaired individuals at intervals of 30, 90, and 180 days. The study will also evaluate changes in oral hygiene status using the OHI-S index, comparing the effectiveness of different teaching methods—Audio alone, Audio with Braille, and Audio with Model. Additionally, participant and institutional satisfaction with the programs will be assessed, along with the effectiveness of weekly reinforcement in enhancing knowledge retention and practices. Finally, intergroup comparisons will be made to determine the most effective learning approach. |
baseline, 30 days, 90 days, 180 days |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
18/11/2024 |
| 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="25"
Months="5"
Days="30" |
|
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
|
This study aims to assess and compare the impact of a customized oral health awareness program on the knowledge and practices of visually impaired individuals in Lucknow. The program involves three methods: audio alone, audio with Braille, and audio with model techniques. Participants’ oral health knowledge and practices will be evaluated at four intervals: baseline, 30 days, 90 days, and 180 days. The goal is to identify which method is most effective in improving oral hygiene among this population. A cluster randomized design will be used, with a minimum sample size of 180 participants. Statistical analyses, including T-tests and chi-square tests, will be applied to compare results, and effect sizes will be calculated to measure the magnitude of the differences. Confounding variables will be controlled, and subgroup analyses will be conducted to explore variations in intervention effects. The study aims to determine the best approach for promoting oral hygiene in visually impaired individuals, improving their overall well-being. |