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

Phase 4UnknownNCT04196829

Cairo University15 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dental Caries in Children

Interventions

silver diamine fluoride ⁄ potassium IodideDRUG

The affected tooth surface will be gently cleaned and dried with cotton gauze. The gingival tissue of the tooth will be protected with petroleum jelly. An applicator will be dipped into the SDF and 3-4 mg applied to the lesion with microbrush which will be used to paint solution over carious lesion then we will wait for 1 minute till absorption . Then after SDF application KI will be applied using a separate microbrush which will be saturated by the solution and will be used to paint solution over carious lesion , no rinse will be performed and special instructions will be given following application

Silver Diamine FluorideDRUG

Eligibility

Sex: ALLMin age: 3 YearsMax age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

staining potential

change in color of carious lesion using spectrophotometer with unit of measurement percent

Time frame: base line and Immediately after material application

Secondary Outcomes

caries arresting effect

evaluating hardness of carious lesion by tactile examination using probe, binary (soft or hard)

Time frame: 3 months, 6 moths, 9 months, 12 months

Data from ClinicalTrials.gov

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