| CTRI Number |
CTRI/2025/05/086881 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two methods to arrest
(stop) caries in milk teeth of children |
|
Scientific Title of Study
|
Evaluation of success of nano silver fluoride modified versus silver diamine fluoride modified atraumatic restorative technique in primary molars – a non-inferiority randomized 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 |
Abhishna P |
| Designation |
Junior resident |
| Affiliation |
AIIMS,New Delhi |
| Address |
Department of paediatric and preventive dentistry,6th floor,CDER,AIIMS
New Delhi
DELHI
110029
India |
| Phone |
9895077423 |
| Fax |
|
| Email |
abhishnaabhi2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kalpana Bansal |
| Designation |
Additional professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
Department of paediatric and preventive dentistry,6th floor, CDER, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810105132 |
| Fax |
|
| Email |
drkalpanabansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishna P |
| Designation |
Junior resident |
| Affiliation |
AIIMS,New Delhi |
| Address |
Department of paediatric and preventive dentistry,6th floor, CDER, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9895077423 |
| Fax |
|
| Email |
abhishnaabhi2@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Abhishna P |
| Address |
Department of paediatric and preventive dentistry,6th floor, CDER, AIIMS, New Delhi |
| 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 Abhishna P |
Centre for dental education and research |
Room no 612,6th floor,Department of paediatric and preventive dentistry,AIIMS,New delhi
New Delhi
DELHI |
9895077423
abhishnaabhi2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee for post graduate research |
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 |
Nano silver modified ART |
Nano Silver Fluoride (NSF), a newer formulation containing silver nanoparticles, chitosan, and fluoride, offers a promising alternative. It exhibits strong antimicrobial properties, arrests caries without causing discoloration, and has shown better parental acceptance. The procedures of history taking and oral examination will take 5 minutes. After the oral examination, Nano silver fluoride application and GIC restorations will be done which will take another 30 minutes. Total duration of entire procedure will be 35 minutes. During follow up, the restoration will be evaluated in 10 minutes.
|
| Comparator Agent |
Silver diamine fluoride modified ART |
Silver Modified Atraumatic Restorative Technique(SMART) have shown promise in managing ECC by arresting caries progression. However, the major drawback of SDF is the black staining it causes on treated teeth, affecting aesthetics and leading to reduced parental and patient acceptance. The procedures of history taking and oral examination will take 5 minutes. After the oral examination, silver diamine fluoride application and GIC restorations will be done which will take another 30 minutes. Total duration of entire procedure will be 35 minutes. During follow up, the restoration will be evaluated in 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Apparently healthy children in the age group 4-9 years.
2.Asymptomatic dentinal cavitated lesions accessible to hand instrumentation in at least one primary molar.
3.Children with Frankl behavior rating scale positive or definitely positive.
4.Children whose parents have consented to take part in the study and whose parents accept to report for the scheduled follow up
|
|
| ExclusionCriteria |
| Details |
1.Teeth with a history of pain in the tooth of interest, signs of pulpal and periapical pathology, such as having an abscess, fistula or sinus.
2.Children with developmental defects/hypoplasia in relation to the selected tooth.
3.Physiologic tooth mobility due to root resorption.
4.Children with known allergy to silver.
5.Children with designated molars having more than two surfaces involved with caries.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the success of atraumatic restorative technique on asymptomatic cavitated carious lesions in primary molars following pretreatment with either nano silver fluoride or silver diamine fluoride solution. |
6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate & compare the degree of discolouration caused by the two atruamatic restorative techniques. |
6 & 12 months |
| To compare & measure the parental satisfaction with the children’s dental appearance after treatment with two restorative techniques |
6 & 12 months |
|
|
Target Sample Size
|
Total Sample Size="288"
Sample Size from India="288"
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)
|
20/05/2025 |
| 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="8"
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
|
This is a non inferiority randomized controlled trial using a parallel study design comparing nano silver modified atraumatic restorative technique with silver diamine modified atraumatic restorative technique in terms of clinical success ,degree of discoloration and parental satisfaction at follow up visit. |