| CTRI Number |
CTRI/2024/10/075595 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Dentistry |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect of health education and availability of dental care in nearby vicinity on utilization of dental services |
|
Scientific Title of Study
|
Assessment of impact of dental health education and spatial accessibility of oral health care facilities using geo-mapping on oral health care services utilization in residents of Andhra Pradesh state, India- A cluster randomized 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 Vundavalli Sudhakar |
| Designation |
Phd Scholar |
| Affiliation |
Saveetha dental College and Hospitals |
| Address |
Dept of Public Health dentistry,
Saveetha dental college,
Saveetha Nagar, Thandalam, Kanchipuram - Chennai Rd, Chennai, Tamil Nadu
Chennai
TAMIL NADU
602105
India |
| Phone |
8330988055 |
| Fax |
|
| Email |
vsudhakar2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vundavalli Sudhakar |
| Designation |
Phd Scholar |
| Affiliation |
Saveetha dental College and Hospitals |
| Address |
Dept of Public Health dentistry,
Saveetha dental college,
Saveetha Nagar, Thandalam, Kanchipuram - Chennai Rd, Chennai, Tamil Nadu
Chennai
TAMIL NADU
602105
India |
| Phone |
8330988055 |
| Fax |
|
| Email |
vsudhakar2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MI Armugham |
| Designation |
Professor and Head |
| Affiliation |
Saveetha dental College |
| Address |
Dept of Public Health dentistry,
Saveetha dental college,
Saveetha Nagar, Thandalam, Kanchipuram - Chennai Rd, Chennai, Tamil Nadu
Chennai
TAMIL NADU
602105
India |
| Phone |
8939496363 |
| Fax |
|
| Email |
drmei.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Sudha Smile Dental Clinic,
DNo.163/1, Opp. Madhavi Nursing Home, Tilak Road, Rajamahendravaram,
Andhrapradesh, India-533101
|
|
|
Primary Sponsor
|
| Name |
Dr Vundavalli Sudhakar |
| Address |
Dept Of Public Health Dentistry,
Saveetha Dental College and Hospital, Ponamalle highway, Chennai |
| Type of Sponsor |
Other [self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vundavalli Sudhakar |
Krishna district- Rural households |
2. a)ward numbers 11 & 14, Kesarapalli village, krishna district, Andhrapradesh-
521102
Krishna
ANDHRA PRADESH |
8330988055
vsudhakar2000@gmail.com |
| Dr Vundavalli Sudhakar |
Krishna district- Urban households |
ward number 3, Ramavarappadu, Vijayawada urban, krishna district, Andhrapradesh 521108
Krishna
ANDHRA PRADESH |
8330988055
vsudhakar2000@gmail.com |
| Dr Vundavalli Sudhakar |
West Godavari district -Rural households |
1. a) Ward numbers 1&2, Mounjipadu Village, Pentapadu Mandal, West Godavari Dist, Andhrapradesh- 534165
West Godavari
ANDHRA PRADESH |
8330988055
vsudhakar2000@gmail.com |
| Dr Vundavalli Sudhakar |
West Godavari district-Urban |
Ward number 6, Tadepalligudem town, West Godavari Dist, Andhrapradesh, India-534101
West Godavari
ANDHRA PRADESH |
8330988055
vsudhakar2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
| Saveetha Dental College-Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health education- one time |
Health education will be provided once baseline data collection is complete.
Duration: 1 year.
Comparison of dental visits before and after 1 year of health education |
| Comparator Agent |
No health education |
Dental visits at baseline and after 1 year to asses the annual dental visit rate |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
74.00 Year(s) |
| Gender |
Both |
| Details |
Individuals who gave voluntary consent for participation.
Individuals who are physically and emotionally fit, able to understand health education |
|
| ExclusionCriteria |
| Details |
Individuals who lack cognitive abilities to understand dental health education. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Travelling distance to oral health care facility (less than 5km, 5 to 10 km and more than 10 km), travelling period (less than 15 min, 15 to 30 min and more than 30 min) and mean dental service utilization rates.
B) Difference in mean annual dental service utilization rates.
|
Base line and after 12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dental visits |
one year |
|
|
Target Sample Size
|
Total Sample Size="1560"
Sample Size from India="1560"
Final Enrollment numbers achieved (Total)= "1560"
Final Enrollment numbers achieved (India)="1560" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/10/2024 |
| Date of Study Completion (India) |
30/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
TITLE: Assessment of impact of dental health education and spatial accessibility of oral health care facilities using geo-mapping on oral health care services utilization in residents of Andhra Pradesh state, India- A cluster randomized trial. Back ground:The use of dental health services is influenced by their spatial accessibility, which ultimately has an impact on the oral health status. Objective: The aim of this study was to assess the relation between oral health status and spatial accessibility of oral health care facilities using geo-mapping among residents of Andhra Pradesh state. Methods: Neighbourhoods and participants will be selected through Stratified cluster sampling technique (WHO basic oral health survey methods). Geo –mapping software (Q-GIS Pro) will be used to map all oral health care facilities in the selected geographical location. Oral health status will be compared with Proximity to facilities and overlay analysis. Areas will be categorised based on travelling distance to oral health facility (<5km, 5-10 km and >10 km) and travelling period (<15 min, 15-30 min and > 30 min). Oral health assessment will be done by using WHO oral health assessment from 2013. Statistical analysis will be done using statistical package for social sciences (SPSS version 24, IBM corp. USA) |