| CTRI Number |
CTRI/2018/04/013389 [Registered on: 20/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
17/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the benificial effect of chlorhexidine-fluoride gel and fluoride varnish on dental caries |
|
Scientific Title of Study
|
Effect of Chlorhexidine-Fluoride gel and fluoride varnish on active caries among 9-12 year old children in Bangalore city: A comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sourabha K G |
| Designation |
Senior Lecture |
| Affiliation |
Dayananda Sagar College of Dental Sciences |
| Address |
Department of Public Health Dentistry
Dayananda sagar college of dental sciences
shavige malleshwara hills
kumarswamy layout
Victoria Hospital
Near City Market Kalasipalayam
Bengaluru
Karnataka
560002
Bangalore
KARNATAKA
560078
India |
| Phone |
9945137853 |
| Fax |
|
| Email |
dr11sourabha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ManjunathPPuranik |
| Designation |
Professor and HOD |
| Affiliation |
Government Dental College and Research Institute |
| Address |
Department of Public Health Dentistry
Victoria Hospital
Near City Market
Kalasipalayam
Bangalore
KARNATAKA
560002
India |
| Phone |
9449353812 |
| Fax |
|
| Email |
m_p_puranik@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sourabha K G |
| Designation |
Senior Lecture |
| Affiliation |
Dayananda Sagar College of Dental Sciences |
| Address |
Department of Public Health Dentistry
Dayananda sagar college of dental sciences
shavige malleshwara hills
kumarswamy layout
Victoria Hospital
Near City Market Kalasipalayam
Bengaluru
Karnataka
560002
Bangalore
KARNATAKA
560078
India |
| Phone |
9945137853 |
| Fax |
|
| Email |
dr11sourabha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sourabha K G
Department of Public Health Dentistry
Government Dental College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Sourabha K G |
| Address |
No 434
Pratham building
5th stage
6th block
Banashankari
Near RV college of architecture
Chikkegowdanapalya |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sourabha K G |
Government Dental College and Research Institute |
Department of Public Health Dentistry
Near City Market
Kalasipalayam
Bangalore
KARNATAKA |
9945137853
dr11sourabha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TheGovernment Dental College, Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with good oral health and who gave informed consent to participate in the study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CERVITEC GEL |
CERVIEC GEL CONTAINS
0.2% Chlorhexidine and
900 ppm Fluoride |
| Comparator Agent |
Control Group |
No treatment done |
| Intervention |
PROFLUORIDE VARNISH |
Profluoride varnish is a colophony-based varnish containing 5% sodium fluoride |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children of age 9-12 years
Children free of any systemic diseases
Children whose parents give consent for the procedures
School children with active intact caries according to nyvad criteria |
|
| ExclusionCriteria |
| Details |
Children with multiple lesions on the same tooth
Children with any systemic diseases and who were taking medication for any illness |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Progression of active caries lesions |
6th month, 12th month and 15th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="163"
Sample Size from India="163"
Final Enrollment numbers achieved (Total)= "163"
Final Enrollment numbers achieved (India)="163" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/03/2010 |
| Date of Study Completion (India) |
18/06/2012 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Randomized controlled trial was done to assess
the effect of Chlorhexidine-Fluoride gel and Fluoride varnish on active caries
among 9-12 year old school children from 8 schools of Bangalore city. Children
were randomly allocated to 3groups i.e Chlorhexidine-fluoride gel group,
profluoride varnish group and control group. Children who fulfilled the
eligibility criteria were chosen. At the baseline, the children underwent oral
prophylaxis and cavitated lesions were restored with Type II GIC as needed. Active
enamel caries were recorded using Nyvad’s Colleagues criteria (1999).
Supervised tooth brushing was performed weekly thrice for
Chlorhexidine-Fluoride gel group. Profluoride Varnish application was done at
Baseline, 6th month and 12th month and No intervention
was done for control group. The effect of chlorhexidine-fluoirde varnish was
evaluated at 6, 12 and 15 months. |