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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries in Children

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

First Posted
December 8, 2019
Last Updated
September 2, 2021
Sponsor
Cairo University
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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

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