CTRI Number |
CTRI/2018/05/013985 [Registered on: 21/05/2018] Trial Registered Retrospectively |
Last Modified On: |
22/06/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Screening Dentistry Behavioral Other (Specify) [oral health education] |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Effect of Oral health education among 12-15 year old school children in Dharan |
Scientific Title of Study
|
Effectiveness of oral health education intervention strategies among 12-15-year-old school children in Dharan, Nepal: A randomized controlled trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
IRC/1086/017 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Krishna Subedi |
Designation |
Junior resident |
Affiliation |
B.P. Koirala Institute of Health Sciences (BPKIHS)-Dharan, Nepal |
Address |
College of Dental Surgery, Department of Public Health Dentistry, BPKIHS-DHARAN,NEPAL
56700 Other |
Phone |
977-9842172496 |
Fax |
|
Email |
idebusanhsirk.ks@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ashish Shrestha |
Designation |
Additional Professor |
Affiliation |
B.P.KOIRALA INSTITUTE OF HEALTH SCIENCES (BPKIHS)-DHARAN, NEPAL |
Address |
College of Dental Surgery, Department of Public Health Dentistry, BPKIHS-DHARAN,NEPAL
56700 Other |
Phone |
977-9842155112 |
Fax |
|
Email |
shrestha.ashish@bpkihs.edu |
|
Details of Contact Person Public Query
|
Name |
Dr Krishna Subedi |
Designation |
Junior resident |
Affiliation |
B.P. Koirala Institute of Health Sciences (BPKIHS)-Dharan, Nepal |
Address |
College of Dental Surgery, Department of Public Health Dentistry, BPKIHS-DHARAN,NEPAL
56700 Other |
Phone |
977-9842172496 |
Fax |
|
Email |
idebusanhsirk.ks@gmail.com |
|
Source of Monetary or Material Support
|
B.P.Koirala Institute of Health Sciences (BPKIHS)Department of public health dentistry, college of dental surgery, Dharan,Nepal |
|
Primary Sponsor
|
Name |
Department of public health dentistry college of dental surgery BPKIHSDharanNepal |
Address |
Department of public health dentistry, college of dental surgery, BPKIHS-Dharan,Nepal |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
Nepal |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Krishna Subedi |
B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan |
Public Health Dentistry, Room no 6
|
977-9842172496
idebusanhsirk.ks@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Review Committee (IRC),BPKIHS,Dharan,Nepal |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Oral health |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Oral health education |
Oral health education is given by using active and passive method |
Comparator Agent |
oral health examination |
oral health is assessed without giving health education |
|
Inclusion Criteria
|
Age From |
12.00 Year(s) |
Age To |
15.00 Year(s) |
Gender |
Both |
Details |
Secondary schools providing co-education and
Cooperative 12-15 years old school Children whose parents give their consent
|
|
ExclusionCriteria |
Details |
Children with any systemic disease,Children requiring any emergency dental treatment,Children with orthodontic appliances ,and Children involved in similar other studies |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Effectiveness of oral health education will be assessed by calculating mean score of oral hygiene knowledge, attitude and practices, plaque control and gingival health among 12-15-year-old school children in Dharan. |
3 months and 6 months after baseline data collection |
|
Secondary Outcome
|
Outcome |
TimePoints |
i)Effectiveness of active and passive methods of oral health education
ii) Effectiveness of oral hygiene knowledge, attitude and practices of 12-15-year-old school children studying in public and private schools of Dharan
iii) Impact of an oral health education in terms of plaque control, gingival health and dentition status in 12-15-year-old school children studying in public and private schools of Dharan
|
3 and 6 months after baseline data collection |
|
Target Sample Size
|
Total Sample Size="240" Sample Size from India="240"
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)
|
Date Missing |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
17/01/2018 |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Not Applicable |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized, single blind,parallel group measuring the effectiveness of oral health education among 12-15-year-old school children in 240 students studying in 12 government and private school for a period of of 6 months in Dharan,Nepal. Oral health education will be reinforced at third and and six months to the the intervention group. The outcome will be assessed at third and sixth months in both the groups. The primary outcome measure will be mean score of oral hygiene knowledge, attitude and practices, plaque control measured by Turesky-Gilmore-Glickman modification of the Quigley-Hein plaque index (1970) and gingival condition by using Gingival index (Loe H and Silness J 1963) in intervention and comparison group. The secondary outcome will be the score of oral hygiene knowledge, attitude and practices, plaque control measured by Turesky-Gilmore-Glickman modification of the Quigley-Hein plaque index (1970) and gingival condition by using Gingival index (Loe H and Silness J 1963) comparing in government and private school,active and passive method of education in the intervention group. |