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

Dental Caries in Children Clinical Trial

Official title:

Comparative Evaluation of Staining Potential and Caries Arresting Effect of Silver Diamine Fluoride⁄Potassium Iodide and Silver Diamine Fluoride in Carious Primary Anterior Teeth

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04196829
• Other study ID #: SDF staining potential
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 2, 2020
• Est. completion date: October 2021

Study information

• Verified date: September 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: October 2021
• Est. primary completion date: August 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Drug:
• silver diamine fluoride / potassium Iodide
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 Fluoride
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 .

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	post operative pain	asking the patient, Binary (present or absent)	3 months, 6 moths, 9 months, 12 months
Primary	staining potential	change in color of carious lesion using spectrophotometer with unit of measurement percent	base line and Immediately after material application
Secondary	caries arresting effect	evaluating hardness of carious lesion by tactile examination using probe, binary (soft or hard)	3 months, 6 moths, 9 months, 12 months