FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
Close