| CTRI Number |
CTRI/2024/06/069254 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
17/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparision of oral health education intervention on oral health knowledge, attitude, practices and oral hygiene status among literate and illiterate adult population in Bheemunipatnam Mandal - A non-randomized controlled trail. |
|
Scientific Title of Study
|
Effectiveness of oral health education intervention on oral health knowledge, attitude, practices and oral hygiene status among literate and illiterate adult population in Bheemunipatnam Mandal - A non-randomized controlled trail. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sodadasi Deevena Hadassah |
| Designation |
Post graduate student |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Room no 5, Department of Public Health Dentistry, Anil Neerukonda Institute Of Dental Sciences, Sangivalasa, Visakhapatnam.
ANDHRA PRADESH
531162
India
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
7036979432 |
| Fax |
|
| Email |
sdhadassah19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Vamsi Krishna Reddy |
| Designation |
Professor and Head of Department |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Room no 5, Department of Public Health Dentistry, Anil Neerukonda Institute Of Dental Sciences, Sangivalasa, Visakhapatnam.
ANDHRA PRADESH
531162
India
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9908200033 |
| Fax |
|
| Email |
drvamsired@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sodadasi Deevena Hadassah |
| Designation |
Post graduate student |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Room no 5, Department of Public Health Dentistry, Anil Neerukonda Institute Of Dental Sciences, Sangivalasa, Visakhapatnam.
ANDHRA PRADESH
531162
India
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
7036979432 |
| Fax |
|
| Email |
sdhadassah19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anil Neerukonda Institute of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
Sodadasi Deevena Hadassah |
| Address |
Room no 5, Department of Public Health Dentistry, Anil Neerukonda Institute of Dental Sciences, Sangivalsa, Visakhapatnam
Andhra Pradesh
531162
India |
| Type of Sponsor |
Private 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 |
| Sodadasi Deevena Hadassah |
Anil Neerukonda Institute of Dental Sciences |
Room no 5, Department of Public Health Dentistry, Anil Neerukonda Institute of Dental Sciences, Sangivalasa- 531162 Visakhapatnam
Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH |
7036979432
sdhadassah19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee-Anil Neerukonda Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening Interventions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
oral health education |
the oral health education on the importance of oral health, tooth brushing techniques, flossing techniques and its impact on gingival and periodontal health.
oral health education is given twice for about 30 minutes each time. |
|
|
Inclusion Criteria
|
| Age From |
31.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Participants who had given consent.
Participants who have minimum knowledge to read local language or English will be taken as literates.
Participants who don’t know to read and write will be taken as illiterates.
|
|
| ExclusionCriteria |
| Details |
Subjects who will migrate to another place within the study period.
Subjects who are undergoing any dental treatment at present or previously visited dentist in the previous year.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| oral hygiene knowledge attitude and practices using a kap questionnaire |
baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| oral hygiene status using plaque and gingival indices |
baseline and 6 months |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/12/2024 |
| 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="1"
Months="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Aim of the study is to determine the effectiveness of oral health education on the oral health knowledge, attitude, practices and oral hygiene status of literate and illiterate adult population in Bheemunipatnam Mandal. For literate adult population group, school teachers will be selected from schools list obtained from mandal educational officer and for illiterate adult population group, supporting staff working in the same schools will be selected. Baseline scores of oral hygiene status will be recorded. Both the literate and illiterate groups will be given the oral health education on the importance of oral health, tooth brushing techniques, flossing techniques and its impact on gingival and periodontal health. The intra group assessment of knowledge, attitude and practices will be done before and after the intervention with the help of a questionnaire which will be available in English and also translated into the local language. For the illiterates, questionnaire will be filled by a second investigator. Reinforcement of oral health education will be given for both literates and illiterates during the 3rd month. The oral hygiene status after the reinforcement will be evaluated and compared by the principal investigator after 6 months interval. |