| CTRI Number |
CTRI/2023/08/056204 [Registered on: 07/08/2023] Trial Registered Prospectively |
| Last Modified On: |
06/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Dentistry |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
School Dental program and dental review after 6 months. |
|
Scientific Title of Study
|
Effectiveness of school dental screening programme and
different referral mechanisms on caries experience among 6 to 11 years old children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr BANKURU HIMABINDU |
| Designation |
PG STUDENT- MDS PEDODONTICS AND PREVENTIVE DENTISTRY |
| Affiliation |
VISHNU DENTAL COLLEGE |
| Address |
DEPARTMENT OF PEDODONTICS AND PREVENTIVE
DENTISTRY, VISHNU DENTAL COLLEGE, VISHNUPUR,
BHIMAVARAM.
West Godavari
ANDHRA PRADESH
534202
India
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7989846647 |
| Fax |
|
| Email |
himabindubankuru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ULOOPI KS |
| Designation |
Professor |
| Affiliation |
VISHNU DENTAL COLLEGE |
| Address |
Room number 5,
Department of pedodontics and Preventive dentistry,
block 3,
Vishnu Dental College, Vishnupur,
Bhimavaram-534202
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
08816251288 |
| Fax |
|
| Email |
uloopiks@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BANKURU HIMABINDU |
| Designation |
PG STUDENT- MDS PEDODONTICS AND PREVENTIVE DENTISTRY |
| Affiliation |
VISHNU DENTAL COLLEGE |
| Address |
DEPARTMENT OF PEDODONTICS AND PREVENTIVE
DENTISTRY, VISHNU DENTAL COLLEGE, VISHNUPUR,
BHIMAVARAM.
West Godavari
ANDHRA PRADESH
534202
India
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7989846647 |
| Fax |
|
| Email |
himabindubankuru@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 5,
Department of pedodontics and Preventive dentistry,
block 3,
Vishnu Dental College, Vishnupur,
Bhimavaram-534202 |
|
|
Primary Sponsor
|
| Name |
Vishnu Dental College |
| Address |
Vishnu Dental College, Bhimavaram |
| Type of Sponsor |
Other [[private dental 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 |
| DrHimabindu Bankuru |
Vishnu dental college |
NUMBER-5,
DEPARTMENT OF
PEDODONTICS AND
PREVENTIVE
DENTISTRY,
West Godavari
ANDHRA PRADESH
West Godavari
ANDHRA PRADESH |
7989846647
himabindubankuru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE VISHNU DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K023||Arrested dental caries, (2) ICD-10 Condition: K025||Dental caries on pit and fissure surface, (3) ICD-10 Condition: K026||Dental caries on smooth surface, (4) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Oral screening will be done in schools.DMFT/deft scores will be recorded and oral health
education will be given.Evaluation of dmft scores will be done after 6 months. |
| Intervention |
Test group |
Screening will be done,Dmft scores will be recorded.Children will be
brought to Department of Pedodontics, Vishnu Dental College for
sensitization about dental operatory and also offered one of the
preventive procedure like oral prophylaxis/sealant application/
Topical fluoride application, and Children will be instructed to get
their parents for further treatments.After 6 months, followup is done for
DMFT/deft scores. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of age 6 to11 years.
2. Children willing to participate in the study with signed
consent from parents.
3. Children with atleast one decayed tooth. |
|
| ExclusionCriteria |
| Details |
1. Participation in another trial.
2. Children with any special health care needs.
3. Children requiring emergency dental treatments |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• To assess the change in caries experience among
children following school dental screening with referral
to any dental facility. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the change in caries experience among
children, following school dental screening with single
visit to specific dental facility for preventive treatment |
6 months |
|
|
Target Sample Size
|
Total Sample Size="620"
Sample Size from India="620"
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)
|
16/08/2023 |
| 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="0"
Months="9"
Days="0" |
|
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
|
Dental caries is one of the most common diseases affecting
children despite the availability of dental services. School
based dental screening could be a potential intervention that
impacts uptake of dental services and subsequently, dental
caries levels. The effectiveness of school dental screening to
improve child dental attendance and oral health remains
unknown. Hence the present study is planned to asses the impact of School based dental screening on dental caries. Permission will be obtained from the school authorities for
screening of 6 to 11 years old children, Following screening
children will be included as per inclusion criteria. Details of the
study will be explained to parents and informed consent will be
obtained. Schools will be randomly assigned into two groups,
through cluster randomization into test group(n=310) and control
group(n=310). Number of decayed teeth will be recorded and oral health
education is given in both groups. In test group, Children will be
brought to Department of Pedodontics, Vishnu Dental College for
sensitization about dental operatory and also offered one of the
preventive procedure like oral prophylaxis/sealant application/
Topical fluoride application, and Children will be instructed to get
their parents for further treatments. Whereas in control group
children will be referred to Vishnu Dental college (or) some other
dental facility for treatments. After 6 months, followup number of decayed teeth and the obtained data will be subjected to
statistical analysis
|