| CTRI Number |
CTRI/2024/04/066113 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Diagnostic
Preventive
Screening
Dentistry
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of discolouration of anticariogenic material applied in two intervals comparison study. |
|
Scientific Title of Study
|
Evaluation of discolouration after application of Silver Diamine Fluoride
in Indirect Pulp Capping of young permanent molars with immediate or
delayed Glass Ionomer Cement and Composite Resin Restoration. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Keyuri Patil |
| Designation |
Post graduate Student |
| Affiliation |
Dr HSRSM Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Dr HSRSM Dental College and Hospital, basamba phata Akola road, hingoli.
Hingoli
MAHARASHTRA
431513
India |
| Phone |
8433694856 |
| Fax |
|
| Email |
keypat1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G. V. Babu |
| Designation |
Head of the Department |
| Affiliation |
Dr HSRSM Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Dr HSRSM Dental College and Hospital, basamba phata Akola road, hingoli.
Hingoli
MAHARASHTRA
431513
India |
| Phone |
9302785659 |
| Fax |
|
| Email |
babupedo99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Keyuri Patil |
| Designation |
Post graduate Student |
| Affiliation |
Dr HSRSM Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Dr HSRSM Dental College and Hospital, basamba phata Akola road, hingoli.
Hingoli
MAHARASHTRA
431513
India |
| Phone |
8433694856 |
| Fax |
|
| Email |
keypat1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr HSRSM Dental College and Hospital, basamba phata, Akola road, Hingoli, Maharashtra, India 431513 |
|
|
Primary Sponsor
|
| Name |
Dr Keyuri Patil |
| Address |
Dr HSRSM Dental College and Hospital, Basamba phata, Akola road, Hingoli |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Keyuri Patil |
Dr HSRSM Dental College and Hospital |
Department of Pediatric and Preventive Dentistry, Akola road, Basamba phata
Hingoli
MAHARASHTRA |
8433694856
keypat1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr HSRSM Dental College and Hospital, Basamba Phata, Akola road, Hingoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, (2) ICD-10 Condition: Z001||Encounter for newborn, infant andchild health examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Composite Resin |
Ivoclar |
| Comparator Agent |
Glass Ionomer Cement |
Type 9 high strength posterior restorative |
| Intervention |
Silver Diamine Fluoride |
e-SDF (e-SDF, 38% silver diamine fluoride, Kids-e-dental LLP,
Globus Medisys, Mumbai, India)
Immediate and 1 Week duration |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between the age of 6 to 12 years.
2. Patients with presence of at least one carious lesion in any of
permanent molars extending up to dentin without involving the
pulp will be selected (According to The International Caries
Detection and Assessment System II codes and criteria, code 5
and 6 will be included).
3. Patients with the absence of periodontal disease.
4. Only those children whose parents will give sign on informed
consent for participation in the study.
5. Patients willing to attend the follow-up visits as required for the
trial. |
|
| ExclusionCriteria |
| Details |
1. Teeth with history of spontaneous pain.
2. Teeth that show signs of arrested carious lesion.
3. Cavitated teeth with pain on percussion, history of swelling, or
sinus tract.
4. Developmental abnormalities of enamel and dentin.
5. Known silver allergy.
6. Medically compromised patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine whether immediate or delayed restoration causes
less discoloration after SDF Application.
2. To determine whether Composite or Glass Ionomer Cement
restoration causes less discoloration after SDF application |
4 weeks, 12 weeks, 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate longevity of restorations after SDF Application,
clinically & radiographically. |
4 weeks, 12 weeks, 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="10"
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)
|
04/05/2024 |
| 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="1"
Months="8"
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
|
This study is a Randomized Controlled Trial to evaluate discolouration of silver diamine fluoride applying in two intervals and their efficacy and also evaluating longevity of restorations after SDF Application,
clinically and radiographically. |