Staining Potential and Caries Arresting Effect of Silver Diamine Fluoride⁄Potassium Iodide and Silver Diamine Fluoride

Phase 4

• Conditions: Dental Caries in Children
• Interventions: Drug: Silver Diamine Fluoride; Drug: silver diamine fluoride ⁄ potassium Iodide

• Registration Number: NCT04196829
• Lead Sponsor: Cairo University

Brief Summary

the main objective of this study is to evaluate staining potential and Caries Arresting Effect of silver diamine fluoride⁄potassium Iodide and silver diamine fluoride in carious anterior primary teeth

Detailed Description

Despite increased attention on caries prevention, not all children receive preventive treatments and large numbers still experience tooth decay. Primary care providers have had little option other than invasive and costly specialist treatment in the hospital under general anesthesia. In this context, there is interest in simple treatments to halt progress of carious lesions after tooth decay onset. Among these simple treatments is silver diamine fluoride (SDF) treatment. The major drawback to SDF treatment has been its black staining, which has limited its use. To counter the staining, researchers have tested SDF treatment immediately followed with application of saturated solution of potassium iodide (KI).

Study Timeline

• Study First Submitted: 2019-12-08
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Study Start: 2020-01-02
• Primary Completion: 2021-08-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-10
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Children with carious primary anterior teeth.
• Children with no spontaneous pain

Exclusion Criteria

• Tooth mobility
• Signs of pulpal or periapical infection
• Severe medical conditions that would not allow management in the clinic
• Sensitivity to silver or other heavy-metal ions
• Presence of any gingival or perioral ulceration or stomatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
silver diamine fluoride	Silver Diamine Fluoride	38% silver diamine fluoride
silver diamine fluoride ⁄ potassium Iodide	silver diamine fluoride ⁄ potassium Iodide	38% silver diamine fluoride and a saturated solution of potassium iodide

Primary Outcome Measures

Name	Time	Method
staining potential	base line and Immediately after material application	change in color of carious lesion using spectrophotometer with unit of measurement percent

Secondary Outcome Measures

Name	Time	Method
caries arresting effect	3 months, 6 moths, 9 months, 12 months	evaluating hardness of carious lesion by tactile examination using probe, binary (soft or hard)

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt