| CTRI Number |
CTRI/2024/03/064408 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
11/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trail to study the effects of resin modified glass ionomer varnish and resin infiltrant on initial carious lesions in primary teeth |
|
Scientific Title of Study
|
Comparative evaluation of effect of resin modified glass ionomer varnish and resin infiltrant on incipient carious lesions in primary teeth :A Randomised Controlled 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 Yogesh Kale |
| Designation |
Professor and Head of Department |
| Affiliation |
maharashtra institute of dental sciences and research,latur |
| Address |
Department of pediatric & preventive dentistry,MIDSR dental college Latur.
Latur MAHARASHTRA 413512 India |
| Phone |
9890588705 |
| Fax |
|
| Email |
dryogesh77@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yogesh Kale |
| Designation |
Professor and Head of Department |
| Affiliation |
maharashtra institute of dental sciences and research,latur |
| Address |
Department of pediatric & preventive dentistry,MIDSR dental college Latur.
Latur MAHARASHTRA 413512 India |
| Phone |
9890588705 |
| Fax |
|
| Email |
dryogesh77@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Anamika Suryawanshi |
| Designation |
Post graduate student |
| Affiliation |
maharashtra institute of dental sciences and research,latur |
| Address |
Room no 6 ground floor Department of pediatric & preventive dentistry,MIDSR dental college Latur.
Latur MAHARASHTRA 413512 India |
| Phone |
9890588705 |
| Fax |
|
| Email |
suryavanshiia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no.6,Department of pediatric and preventive dentistry,Maharashtra institute of dental sciences and research dental college ,latur |
|
|
Primary Sponsor
|
| Name |
Anamika suryawanshi |
| Address |
Room no.6,department of pediatric & preventive dentistry,Maharashtra institute of dental sciences and reserch dental college, latur |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr yogesh kale |
Room no.6,department of pediatric & preventive dentistry,Maharashtra institute of dental sciences and research dental college, latur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr yogesh kale |
Maharashtra institute of dental sciences and research dental college, latur |
Room no.6,department of pediatric & preventive dentistry,Maharashtra institute of dental sciences and research dental college, latur Latur MAHARASHTRA |
9890588705
dryogesh77@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharashtra university of health sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Resin infiltrant |
Resin infiltrant (ICON®)
-The tooth to be treated will be isolated.
-The infiltration procedure will be carried out following the user manual.
- Finishing and polishing will be done with fine-graded abrasive flexible discs,
finishing strips, and rubber cups.
-Total procedure will take 45 minutes to 1 hour overall.
ASSESSMENT OF CARIES PROGRESSION FOR BOTH THE GROUPS WILL BE DONE AT
3,6,9 MONTHS INTERVAL.
Pre and post Caries assessment, evaluation & progresssion will be done using :
-Standardised ICDAS scale and Radiograph |
| Comparator Agent |
Resin modified glass ionomer varnish
|
Premeasured liquid and paste mix of the resin modified glass ionomer varnish will be dispensed from
the clicker dispenser, mixed according to manufacturer’s instructions, and applied
as a thin layer along the fissures using a micro-applicator tip.ASSESSMENT OF CARIES PROGRESSION FOR BOTH THE GROUPS WILL BE DONE AT
3,6,9 MONTHS INTERVAL.
Pre and post Caries assessment, evaluation & progresssion will be done using :
-Standardised ICDAS scale and Radiograph
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Child with incipient carious lesions on enamel surface or outer third of dentin
as by radiographic examination.
Non cavitated lesions assessed by ICDAS scale.
Parents willing to commit followup visits. |
|
| ExclusionCriteria |
| Details |
Child with incipient carious lesions extending beyond the outer third of
dentin assessed by radiographic examination
Cavitated lesions assessed by ICDAS scale.
Known allergies to any material component or existing contact allergies. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
caries arresting ability of Resin modified glass ionomer varnish and Resin infiltrant on incipient carious lesions of primary
teeth.
|
9 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| caries prevention ability of Resin modified glass ionomer varnish & Resin infiltrant on incipient carious lesions of primary teeth. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
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 2 |
|
Date of First Enrollment (India)
|
25/04/2024 |
| 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 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
|
Dental caries is a major public health concern commonly afecting children in their early childhood.It has a negative impact on childrens oral as well as general health.
Special attention has been devoted to early incipient carious lesions, with
maximum preservation of tooth structure. This is mainly because restorative
therapy for interproximal lesions requires removal of a substantial amount of
sound tissue and this brings tooth into a circle of treatment and retreatment.
Therefore, early detection and treatment of such lesions will limit the need for
invasive treatment in the future. Infiltration Concept is a relatively new resin product developedin
Germany and used in the treatment of incipient lesions. It improves the
retention and prevents caries on smooth surfaces, but not pit and fissure
surfaces.Resin infiltration is a micro-invasive method that fills the incipient lesion
pores via capillary action , which blocks further diffusion of the bacteria by
creating barriers and stops lesion development, restoring the tooth without
anaesthesia and drilling to preserve the natural anatomy of the tooth form. It infiltrates the lesion, make the bacteria inactive and prevents caries
progression compared to the sealant which only work as mechanical barrier
between the tooth structure and the oral environment. Fluoride varnishes
are effective in preventing caries and their administration is the method of
choice to prevent demineralization, as well as to enhance the remineralization
of non-cavitated carious lesions.Resin modified glass ionomer varnish is a site
specific, light cured durable, fluoride releasing coating that provides an immediate
layer of protection to relieve dentinal hypersensitivity, creates a barrier against
demineralization and acid erosion and helps repair demineralized enamel adjacent
to the coating. Hence this study focusses to clinically assess the efficacy of the Resin
modified glass ionomer varnish versus Resin infiltrant on incipientcarious lesion. |