Staining Potential and Caries Arresting Effect of Silver Diamine Fluoride⁄Potassium Iodide and Silver Diamine Fluoride
Primary Purpose
Dental Caries in Children
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
silver diamine fluoride ⁄ potassium Iodide
Silver Diamine Fluoride
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries in Children
Eligibility Criteria
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
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
silver diamine fluoride ⁄ potassium Iodide
silver diamine fluoride
Arm Description
38% silver diamine fluoride and a saturated solution of potassium iodide
38% silver diamine fluoride
Outcomes
Primary Outcome Measures
staining potential
change in color of carious lesion using spectrophotometer with unit of measurement percent
Secondary Outcome Measures
caries arresting effect
evaluating hardness of carious lesion by tactile examination using probe, binary (soft or hard)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04196829
Brief Title
Staining Potential and Caries Arresting Effect of Silver Diamine Fluoride⁄Potassium Iodide and Silver Diamine Fluoride
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
August 12, 2021 (Actual)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
silver diamine fluoride ⁄ potassium Iodide
Arm Type
Experimental
Arm Description
38% silver diamine fluoride and a saturated solution of potassium iodide
Arm Title
silver diamine fluoride
Arm Type
Active Comparator
Arm Description
38% silver diamine fluoride
Intervention Type
Drug
Intervention Name(s)
silver diamine fluoride ⁄ potassium Iodide
Other Intervention Name(s)
SDF / KI
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Silver Diamine Fluoride
Other Intervention Name(s)
SDF
Intervention Description
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 .
Primary Outcome Measure Information:
Title
staining potential
Description
change in color of carious lesion using spectrophotometer with unit of measurement percent
Time Frame
base line and Immediately after material application
Secondary Outcome Measure Information:
Title
caries arresting effect
Description
evaluating hardness of carious lesion by tactile examination using probe, binary (soft or hard)
Time Frame
3 months, 6 moths, 9 months, 12 months
Other Pre-specified Outcome Measures:
Title
post operative pain
Description
asking the patient, Binary (present or absent)
Time Frame
3 months, 6 moths, 9 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariam Aly, Phd
Organizational Affiliation
Lecturer, Faculty of Dentistry, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Staining Potential and Caries Arresting Effect of Silver Diamine Fluoride⁄Potassium Iodide and Silver Diamine Fluoride
We'll reach out to this number within 24 hrs