| CTRI Number |
CTRI/2025/04/084140 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on usefulness of silver diamine fluoride in arresting caries in deciduous teeth of child in age group 3-6 years. |
|
Scientific Title of Study
|
Effectiveness of silver diamine fluoride (SDF) in arresting caries in 3-6 years old children - a community based randomised 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 |
Dr Ajoy Kumar Shahi |
| Designation |
Additional Professor |
| Affiliation |
Rajendra institute of medical sciences |
| Address |
Department of oral and maxillofacial Surgery, Dental Institute, Rajendra Institute of medical sciences, Bariatu
Ranchi JHARKHAND 834009 India |
| Phone |
99553610910 |
| Fax |
|
| Email |
drajoyshahi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ajoy Kumar Shahi |
| Designation |
Additional Professor |
| Affiliation |
Rajendra institute of medical sciences |
| Address |
Department of oral and maxillofacial Surgery, Dental Institute, Rajendra Institute of medical sciences, Bariatu
Ranchi JHARKHAND 834009 India |
| Phone |
99553610910 |
| Fax |
|
| Email |
drajoyshahi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ajoy Kumar Shahi |
| Designation |
Additional Professor |
| Affiliation |
Rajendra institute of medical sciences |
| Address |
Department of oral and maxillofacial Surgery, Dental Institute, Rajendra Institute of medical sciences, Bariatu
Ranchi JHARKHAND 834009 India |
| Phone |
99553610910 |
| Fax |
|
| Email |
drajoyshahi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Model rural health research unit, Community Health Centre, Angara, Ranchi-835103, Jharkhand, India |
|
|
Primary Sponsor
|
| Name |
Model rural health research unit |
| Address |
Model rural health research unit, Community Health Centre, Angara, Ranchi-835103, Jharkhand, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Ajoy Kumar Shahi |
Anganwadi kendras |
Anganwadi kendras od Anagara block, Angara, Ranchi Ranchi JHARKHAND |
9955361090
drajoyshahi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, RIMS, Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
glass ionomer cement (GIC) |
carious tooth treated with glass ionomer cement (GIC) and followed up periodically at interval of 6 months, 12 months, 18 months and 24 months. |
| Intervention |
silver diamine fluoride (SDF) varnish |
carious tooth treated with SDF varnish and followed up periodically at interval of 6 months, 12 months, 18 months and 24 months. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
At least one soft caries lesion, i.e, cavitated active caries lesion that is small in size (less than half of the mesial or distal or less than one-third of the buccal, lingual, or occlusal surfaces).
|
|
| ExclusionCriteria |
| Details |
Pulpal exposure, history of pain, nonvital teeth, swelling or fistula, silver allergy, arrested caries or inactive lesions, teeth at the period of shedding, restored teeth, secondary caries, fluorosis, enamel hypoplasia, uncooperative behavior, physical or mental disability, and a lack of signed informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| caries arrest in both experimental and control group |
6 months,12 months,18 months,24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complications associated with treatment |
6 months,12 months,18 months,24 months |
|
|
Target Sample Size
|
Total Sample Size="400" Sample Size from India="400"
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 4 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="2" Months="0" 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
|
Rationale-- Traditional treatment approach of drill-and-fill", is associated with pain and fear for small age children. Traditionally, dental caries treatment requires surgical restorative approach, with sophisticated dental equipment and well-trained operators, and is relatively expensive. SDF offers an alternative innovative treatment option for caries. It is a practical, affordable, and acceptable option for caries treatment, eliminating the need for fear related dental treatment in young children, and can improve long-term oral health outcomes even at community level. Novelty- This study is probably the first one to investigate the effectiveness of SDF 38% and GIC in arresting caries of young children of rural area at community level program. Due to the under-developed oral health care system at rural level, most of the decayed teeth in children remain untreated. Untreated dental caries in children can lead to problems with food intake, sleep, daily activities, and self-esteem. Caries arrest treatment with SDF is a non- invasive acceptable and affordable treatment option. Evidence that SDF is comparable in the treatment of dental caries in a school setting may substantially improve the reach and effectiveness of caries prevention as a dental public health intervention |