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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Caries in Children
• Intervention / Treatment: Drug: silver diamine fluoride ⁄ potassium Iodide; Drug: Silver Diamine Fluoride

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: silver diamine fluoride ⁄ potassium Iodide; 38% silver diamine fluoride and a saturated solution of potassium iodide	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; Other Names: SDF / KI
Active Comparator: silver diamine fluoride; 38% silver diamine fluoride	Drug: 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 .; Other Names: SDF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
staining potential	change in color of carious lesion using spectrophotometer with unit of measurement percent	base line and Immediately after material application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain	asking the patient, Binary (present or absent)	3 months, 6 moths, 9 months, 12 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mariam Aly, Phd, Lecturer, Faculty of Dentistry, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Actual): August 12, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: December 8, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: SDF staining potential

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No