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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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