| CTRI Number |
CTRI/2024/08/072689 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare salivary fluoride concentrations from conventional and iontophoresis-infused topical fluoride gel usage among 8-12 year old children to prevent tooth decay. |
|
Scientific Title of Study
|
Comparative Evaluation of Salivary
Fluoride Concentration from Conventional
Topical Fluoride Gel Application and
Topical Fluoride Gel Infused via
Iontophoresis among 8–12 Year Old
Children: A Randomised Clinical Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janvi Manish Dave |
| Designation |
Post graduate student |
| Affiliation |
KM shah Dental College |
| Address |
Room no 3 Department of Pediatric and Preventive Dentistry KM shah Dental college Sumandeep Vidyapeeth Piparia Vadodara
Vadodara GUJARAT 391760 India |
| Phone |
9082173008 |
| Fax |
|
| Email |
davejanvi401@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bhavna Dave |
| Designation |
Professor and Head of the Department |
| Affiliation |
KM shah Dental College |
| Address |
Room no 3 Department of Pediatric and Preventive Dentistry KM shah Dental college Sumandeep Vidyapeeth Piparia Vadodara
Vadodara GUJARAT 391760 India |
| Phone |
9998034036 |
| Fax |
|
| Email |
bhavnadave1964@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Janvi Manish Dave |
| Designation |
Post graduate student |
| Affiliation |
KM shah Dental College |
| Address |
Room no 3 Department of Pediatric and Preventive Dentistry KM shah Dental college Sumandeep Vidyapeeth Piparia Vadodara
Vadodara GUJARAT 391760 India |
| Phone |
9082173008 |
| Fax |
|
| Email |
davejanvi401@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrJanvi Dave |
| Address |
Room no 3 Department of Pediatric and Preventive dentistry KM Shah dental college and hospital sumandeep vidyapeeth Piparia Vadodara, Gujarat 391760, India |
| 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 |
| Dr Janvi Dave |
KM Shah dental college and hospital |
Room no 3 Department of Pediatric and Preventive Dentistry Vadodara GUJARAT |
9082173008
davejanvi401@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children at risk of developing dental caries or children with intial signs of dental caries(ICDAS score 0 to 2) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional 1.23%APF gel application |
1.23% is Topical fluoridated product and is able to create reservoirs, providing bioavailability of the
product for the dental surface which is effective in reducing demineralization and
increasing remineralization. To check the efficacy of Intervention group the fluoride application via conventional technique will be used |
| Intervention |
Iontophoreosis infused APF gel application |
Iontophoresis is a non-invasive technique, based on the application of a constant low-intensity
electric current to facilitate the release of a variety of drugs, through the biological
membranes. Iontophoresis enhances the delivery of both charged and uncharged drugs by the
application of an electric current across a membrane. Iontophoresis has a wide range of application in dentistry, to produce a non-invasive
technique of anaesthesia, iontophoresis of fluoride to decrease dentinal hypersensitivity,
iontophoresis of peroxide for teeth whitening and that of nano-particles for re-mineralization
of decalcified enamel and dentin are among the others. Thus, in this study APF gel will be infused via iontophorosis for 4 minutes and fluoride uptake will be assessed by Salivary Fluoride levels will be assessed at 60 minutes, 24 hours and 1 week after fluoride application. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children reporting to the Out-Patient- department accompanied by their parents within the
age group of 8-12 years.Children with FRANKL’s 3 AND 4 behaviour rating scale will be
included.Children with ICDAS score upto 2 |
|
| ExclusionCriteria |
| Details |
Children who are medically compromised and those with special health care needs.Children with dental fluorosis. Children with previous dental restorations. Children who’s parents do not provide consent |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate Salivary
level by infusing
fluoride gel via
Iontophorosis |
Baseline, At 60 minutes, At 24 hours and At 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To achieve more
efficient methods
for caries
prevention. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="3" 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
|
Fluorides have been at the forefront of preventive dentistry ever since their anticariogenic potential was discovered. Topical fluoridated products are able to create reservoirs, providing bioavailability of the product for the dental surface which is effective in reducing demineralization and increasing remineralization. Iontophoresis is a non-invasive technique, based on the application of a constant low-intensity electric current to facilitate the release of a variety of drugs, through the biological membranes. Iontophoresis enhances the delivery of both charged and uncharged drugs by the application of an electric current across a membrane. Iontophoresis has a wide range of application in dentistry, to produce a non-invasive technique of anaesthesia, iontophoresis of fluoride to decrease dentinal hypersensitivity, iontophoresis of peroxide for teeth whitening and that of nano-particles for re-mineralization of decalcified enamel and dentin are among the others. Fluoride levels in whole saliva can be affected by method of delivery, and generally follows the same pattern in plaque samples. Although salivary retention of fluoride does not necessarily reflect anticaries effect, this data can provide some indication of dose- effective methods of topical fluoride application. Barbakow in 19738 suggested that fluoride concentration were greater after the iontophoretic applications Recent invitro studies suggest tha there is increased uptake of fluoride in teeth after iontophoresis. Thus, it is vital to investigate improved fluoride administration systems.
|