| CTRI Number |
CTRI/2020/07/026614 [Registered on: 16/07/2020] Trial Registered Prospectively |
| Last Modified On: |
04/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two types treatment of decayed teeth in primary school children with limited access to dental care. |
|
Scientific Title of Study
|
A six month clinical evaluation of Silver Diamine Fluoride and Atraumatic Restorative Treatment for treating dental caries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharmistha Mohanty |
| Designation |
Post graduate student |
| Affiliation |
Institute of Dental Sciences |
| Address |
Room No 9 Dept of Public Health Dentistry Institute of Dental Sciences K8 Kalinganagar Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
8917592963 |
| Fax |
|
| Email |
sharmisthabolt007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharmashree Satyarup |
| Designation |
Professor |
| Affiliation |
Institute of Dental Sciences |
| Address |
Room No 9 Dept of Public Health Dentistry Institute of Dental Sciences K8 Kalinganagar Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
8008610999 |
| Fax |
|
| Email |
dharmashree_s@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharmashree Satyarup |
| Designation |
Professor |
| Affiliation |
Institute of Dental Sciences |
| Address |
Room No 9 Dept of Public Health Dentistry Institute of Dental Sciences K8 Kalinganagar Bhubaneswar
Kendrapara
ORISSA
751003
India |
| Phone |
8008610999 |
| Fax |
|
| Email |
dharmashree_s@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistry,
Institute of Dental Sciences,
K-8, Kalinganagar, 751003 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
none |
| Type of Sponsor |
Other [None] |
|
|
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 Dharmashree Satyarup |
Institute of Dental Sciences |
Room No 9 Dept of Public Health Dentistry Institute of Dental Sciences K8 Kalinganagar Bhubaneswar
Khordha
ORISSA |
8008610999
dharmashree_s@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Medical Sciences(IMS) and Sum Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M268||Other dentofacial anomalies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Atraumatic Restorative Treatment |
Has been advocated by WHO as the treatment for simple dental caries not involving the pulp, in areas with limited access to dental care. |
| Intervention |
Silver Diamine Fluoride |
Silver Diamine Fluoride has been used for arresting active dental caries. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
International Caries Detection and Assessment System (ICDAS) code V and VI not involving the pulp. |
|
| ExclusionCriteria |
| Details |
Medically compromised patients.
dental caries involving pulp.
Pain and mobility in the tooth. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intact restoration and no secondary caries |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Loss of restoration
2.Discoloration
3.Pain and infection of tooth |
6 months |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
28/09/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Silver Diamine Fluoride(SDF) has been popularised for its ability to stop dental caries formation and concurrently arrest caries progression.This approach does not require caries excavation using instruments, in addition silver has many antimicrobial properties and fluoride which helps in remineralisation. The Atraumatic Restorative Treatment (ART) is a pain free, minimal intervention approach where only hand instruments are used to remove carious tooth substance before the cavity is restored and any adjacent enamel fissures are sealed with conventional , self-hardening Glass Ionomer Cement(GIC).Thus WHO recommends ART as the treatment option for dental caries in areas with limited access to dental care. Hence, this study is being conducted to evaluate if SDF can be used as an effective caries restoration option in school children as opposed to ART, as it removes the use of hand instruments used in ART for caries excavation. Therefore it can be used in children with anxiety for dental treatments and also be done by trained auxillaries instead of dentists in rural areas.
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