| CTRI Number |
CTRI/2026/01/101195 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening Dentistry |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect of introducing an oral health curriculum in improving oral hygiene habits and reducing tooth decay among school children in Angara, Ranchi district — A randomized controlled trial. |
|
Scientific Title of Study
|
Effectiveness of Oral health curriculum in improving oral hygiene behavior,reducing caries increment in school going children of Angara ,Ranchi district- A Randomised control 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 Subhash Chandra |
| Designation |
Additional Professor |
| Affiliation |
Dental Institute, Rajendra institute of Medical Sciences |
| Address |
Department of Orthodontics & Dentofacial Orthopedics, Dental Institute, Rajendra Institute of Medical Sciences, Ranchi Department of Orthodontics & Dentofacial Orthopedics, Dental Institute, Rajendra Institute of Medical Sciences,Bariatu, Ranchi JHARKHAND 834008 India |
| Phone |
9955393983 |
| Fax |
|
| Email |
drscportho@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Subhash Chandra |
| Designation |
Additional Professor |
| Affiliation |
Dental Institute, Rajendra institute of Medical Sciences |
| Address |
Department of Orthodontics & Dentofacial Orthopedics, Dental Institute, Rajendra Institute of Medical Sciences, Ranchi. Department of Orthodontics & Dentofacial Orthopedics, Dental Institute, Rajendra Institute of Medical Sciences, Bariatu. Ranchi JHARKHAND 834008 India |
| Phone |
9955393983 |
| Fax |
|
| Email |
drscportho@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Subhash Chandra |
| Designation |
Additional Professor |
| Affiliation |
Dental Institute, Rajendra Institute of Medical Sciences |
| Address |
Department of Orthodontics & Dentofacial Orthopedics, Dental Institute, Rajendra Institute of Medical Sciences, Ranchi
Ranchi JHARKHAND 834008 India |
| Phone |
9955393983 |
| Fax |
|
| Email |
drscportho@gmail.com |
|
|
Source of Monetary or Material Support
|
| Model Rural Health Research Unit, Angara,ICMR -NIMR,Community Health Centre, Ranchi Purulia Road, Ranchi, Jharkhand,, PIN 835103, India |
|
|
Primary Sponsor
|
| Name |
Model rural health research unit Angara |
| Address |
Angara Community health center,Ranchi, Jharkhand,PIN 835103. |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Dr Subhash Chandra |
Schools of Angara Block |
Angara Block, Ranchi PIN 835103 Ranchi JHARKHAND |
9955393983
drscportho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee.RIMS, Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ORAL DISEASES |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
One year |
| Intervention |
Oral health education |
one year. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
High school students aged 12-15 years (from 7th to 9 th grade will be selected)
Students who are willing to participate in the study and whose parents have given consent.
Students who are mentally and physically fit to participate in study.
|
|
| ExclusionCriteria |
| Details |
Failure to obtain written informed consent from parents.
Students undergoing fixed orthodontic treatment.
Students who are non-cognitive and who have communication problems.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in caries incidence and positive change in OHI –S index score. |
Baseline,six months and one year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of oral health knowledge, attitude & behaviour. |
Baseline, six months & one year. |
|
|
Target Sample Size
|
Total Sample Size="2060" Sample Size from India="2060"
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)
|
01/02/2026 |
| 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="0" 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
|
Pain and tooth loss resulting from oral diseases
adversely affect appearance, nutrition, quality of life, growth and development
of students. The cost of treating dental caries alone is huge on country and
family. Advance stages of dental treatment for caries is not only
painful but it affects their academic performance and put financial burden too.
Oral health education in school children can improve oral hygiene and instil
good eating practice in them The approach suitable
is focus on prevention of Dental caries and gum disease. Aim of this
proposed study is to assess the effectiveness of an oral health curriculum
intervention in reducing dental caries incidence and improving oral hygiene
behaviour among high school children in grades 7–9 of the Angara, Ranchi
district. The present study will be carried out in school premises. Participating Children would be examined by Dentist
in well-lit class rooms under sufficient natural light by using mouth mirror and
probe following strict aseptic protocol. Dental caries, dental health status
and oral hygiene status will be measured by Dentist at beginning, after 6
months and finally after 1 year. As a benefit of participating in the study,
children will be given a referral card from the dental hospital for any further
check-ups or dental treatment. |