| CTRI Number |
CTRI/2024/12/077918 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Improving Oral Health of Elderly Residents in Lucknow Old Age Homes Through Caregiver Training: A Study |
|
Scientific Title of Study
|
Optimizing oral health in elderly residents: A cluster randomized controlled study evaluating the impact of caregiver education in old age homes of Lucknow |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sreeja Gummalla |
| Designation |
MDS student |
| Affiliation |
King Georges Medical College |
| Address |
Department of Public Health Dentistry, 2nd floor, Old Dental Building, Faculty of Dental Sciences, KGMU,Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow UTTAR PRADESH 226018 India |
| Phone |
7661935324 |
| Fax |
|
| Email |
gumallasreejareddy@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Gaurav Mishra |
| Designation |
Additional Proffesor |
| Affiliation |
King Georges Medical College |
| Address |
Department of Public Health Dentistry, 2nd floor, Old Dental Building, Faculty of Dental Sciences, KGMU,Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9651771144 |
| Fax |
|
| Email |
gauravmishra@kgmcindia.edu |
|
Details of Contact Person Public Query
|
| Name |
Sreeja Gummalla |
| Designation |
MDS student |
| Affiliation |
King Georges Medical College |
| Address |
Department of Public Health Dentistry, 2nd floor, Old Dental Building, Faculty of Dental Sciences, KGMU,Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow UTTAR PRADESH 226018 India |
| Phone |
7661935324 |
| Fax |
|
| Email |
gumallasreejareddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistry, 2nd floor, Old Dental Building, Faculty of Dental Sciences, KGMU,Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003, India.
|
|
|
Primary Sponsor
|
| Name |
Sreeja Gummalla |
| Address |
King Georges Medical University,Shah Mina Rd, Chowk, Lucknow - 226003 |
| Type of Sponsor |
Other [self funding] |
|
|
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 Sreeja Gummalla |
king georges medical university, |
Department of Public Health Dentistry, old dental building, 2nd floor, Shah Mina Rd, Chowk, Lucknow - 226003. Lucknow UTTAR PRADESH |
07661935324
gumallasreejareddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe, KGMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
elderly participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional oral health education |
participants will follow their regular oral health practices for 6 months |
| Intervention |
video based elderly oral health awareness to caregivers |
video-based oral health education about elderly population will be provided to caregiver at baseline and 3 months |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants will be required to reside at the institution throughout the entire six-month period.
2. Individuals must provide written informed consent, duly undersigned by either the resident or the resident’s legal representative.
3. Participants should have 10 or more natural teeth or dentures.
4. Participants who are dependent on caregivers for their care.
5. Participants must possess the cognitive and physical conditions necessary for undergoing a comprehensive oral examination
|
|
| ExclusionCriteria |
| Details |
1. In this study, edentulous elderly residents without dentures will be excluded.
2. Individuals who do not sign informed consent will also be excluded from participation.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| oral hygiene status by Simplified Oral Hygiene Index (OHI-S) and the Turesky-Gilmore-Glickman modification of the Quigley Hein Plaque Index |
at Baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| oral health knowledge among caregivers using a 15-item proforma |
baseline and 6th month |
|
|
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)
|
10/01/2025 |
| 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="8" 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
|
After
obtaining permission from institution managers, oral prophylaxis will be done
to all participants one month before the study commencement then institutions
will be randomly allocated to either the study or control group. Baseline data
collection will involve assessing oral health knowledge among caregivers using
a 15-item proforma, documenting the dental conditions of residents with tools
like the Simplified Oral Hygiene Index (OHI-S) and the Turesky-Gilmore-Glickman
modification of the Quigley Hein Plaque Index, and evaluating oral
health-related quality of life using the GOHAI index, along with the Barthel
Index to assess participant dependency. The study group will receive oral
health education for caregivers through a video presentation at baseline,
reinforced after three months, while the control group will continue with
routine care for six months, receiving oral health education afterward.
Follow-up data collection at six months will reassess oral health knowledge and
conditions using the same indices and a follow-up questionnaire. Oral health
education for caregivers in the study group will be reinforced, and the control
group will receive this education at the end of six months. Final data
collection will document oral health outcomes for both groups, followed by
statistical analysis to compare results. |