Application of Silver Diamine Fluoride gel with and without Potassium Iodide solution to arrest caries and prevent discolouration in carious primary molars in children.

Comparative Evaluation of Atraumatic Restorative Treatment (ART), Silver Modified Atraumatic Restorative Technique (SMART) using 38% Silver Diamine Fluoride (SDF) Gel with and without Potassium Iodide (KI) in Carious Primary Molar Teeth using FDI Criteria: A Randomized Clinical Study. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070926

Enrollment

132

Registered

2024-07-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: Silver modified Atraumatic restorative treatment : 1) Silver Diamine Fluoride Gel 2) Silver Diamine Fluoride Gel with potassium iodide solution: To arrest caries Silver Diamine Fluoride

Eligibility

Inclusion criteria

Inclusion criteria: 1) Children between 4 to 8 years of age. 2) Healthy Children with a behaviour rating of 3 or 4 according to Frankl scale. 3) Childrenwho have carious lesion involving enamel and dentin in 1st and 2nd primary molars. 4) Teeth with International Caries Detection Assessment System (ICDAS) score 5 or 6.

Exclusion criteria

Exclusion criteria: 1) The teeth with spontaneous pain, swelling, fistula, abscess or tenderness on percussion will be excluded. 2) Children with Oral Ulceration. 3) Children with history of allergy to silver, fluoride, potassium, iodine, ammonia, or methacrylates. 4) Parents not giving consent for the treatment.

Design outcomes

Primary

Measure	Time frame
To check the efficacy of Potassium Iodide Solution on staining caused by Silver diamine fluoride.Timepoint: at 24 hrs, 3 months and 9 months interval.	—

Secondary

Measure	Time frame
To compare the Caries arresting efficacy in ART (Atraumatic Restorative Treatment) and SMART Technique (Silver modified Atraumatic Restorative Treatment )Timepoint: at 24 hrs, 3 months and 9 months interval.	—

Countries

India

Contacts

Public ContactDr Divya Sanjaykumar Shinde

KM Shah Dental College and Hospital

drseemabargale@gmail.com9586115657

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026