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Clinical and Laboratory Assessments of Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Caries Among Children and Parental Satisfaction

Primary Purpose

Caries Arrested

Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Silver Diamine Fluoride (SDF)
Sponsored by
Khalood Saeed Bahammam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries Arrested

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children between four and six years of age.
  • Healthy.
  • Have at least two active dentin carious lesions on the primary teeth meeting the International Caries Detection and Assessment System (ICDAS) score 5 or 6.
  • Should not have periapical infection, root resorption or widening in the periodontal ligament space.

Exclusion Criteria:

  • Participants who have systemic or neurological diseases.
  • Tooth abscess, pain on percussion, symptoms of pulpal involvement or mobility,
  • Allergic to silver or any dental material to be used.
  • Unable to attend follow-up visits.

Sites / Locations

  • Imam Abdulrahman Bin Faisal UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

one application of SDF

two application of SDF one month apart

Arm Description

Outcomes

Primary Outcome Measures

Effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries.
Caries arresting rate: total number of arrested teeth/ total number of treated teeth.

Secondary Outcome Measures

Clinical changes of dentinal lesion: in the hardness and softness.
Changes in ICDAS score: post treatment change in carious lesion status.
The antibacterial effect of the Silver Diamine Fluoride (SDF).
by DNA extractions and performed the 16S rRNA sequencing
Parents satisfaction
To assess parents' and children's satisfaction and acceptance by questionnaire (Arabic and English). Link: https://forms.office.com/Pages/ResponsePage.aspx?id=_LuGLASN_0GoOpQvB14PYCVJ8_tHLjNCkOqqrov3N-1UMFlYRzFQUVRKMDhNUEtJR1ZXNkk4SzhGWS4u

Full Information

First Posted
October 7, 2020
Last Updated
November 21, 2020
Sponsor
Khalood Saeed Bahammam
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1. Study Identification

Unique Protocol Identification Number
NCT04642846
Brief Title
Clinical and Laboratory Assessments of Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Caries Among Children and Parental Satisfaction
Official Title
Clinical and Laboratory Assessments of Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Caries Among Children and Parental Satisfaction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 21, 2020 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Khalood Saeed Bahammam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Globally, it is estimated that 2.4 billion people suffer from caries of permanent teeth and 486 million children suffer from caries of primary teeth . The highest estimate of dental caries prevalence in Saudi Arabia was 95% with maximum DMFT of 7.34 among 3-7 years old children . Also, it was found that 78% of 6-9 years old children in Dammam had caries with an average of 3.66±3.13 DMFT. The objectives of this study are: To assess the effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries. To assess the antibacterial effect of the Silver Diamine Fluoride (SDF). To assess parents' and children's satisfaction and acceptance. The aims of our study are to assess the effectiveness of SDF in arresting caries in primary dentition among children visiting Imam Abdulrahman bin Faisal University in Dammam, Saudi Arabia and to assess parental acceptance and satisfaction. The expected outcome the results of this study will help in understanding the effectiveness SDF in arresting dental caries in this target population especially that it was recently approved for clinical use in Saudi Arabia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries Arrested

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
one application of SDF
Arm Type
Experimental
Arm Title
two application of SDF one month apart
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Silver Diamine Fluoride (SDF)
Intervention Description
Silver diamine fluoride (SDF) is one of the topical methods for caries arresting. The advantages of using SDF include ease of use, low cost, pain and infection control, minimal requirement of time/training and non-invasive nature of the procedure. SDF can improve oral health, increase access to care and reduce the need for emergency treatment
Primary Outcome Measure Information:
Title
Effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries.
Description
Caries arresting rate: total number of arrested teeth/ total number of treated teeth.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Clinical changes of dentinal lesion: in the hardness and softness.
Description
Changes in ICDAS score: post treatment change in carious lesion status.
Time Frame
2 years
Title
The antibacterial effect of the Silver Diamine Fluoride (SDF).
Description
by DNA extractions and performed the 16S rRNA sequencing
Time Frame
2 years
Title
Parents satisfaction
Description
To assess parents' and children's satisfaction and acceptance by questionnaire (Arabic and English). Link: https://forms.office.com/Pages/ResponsePage.aspx?id=_LuGLASN_0GoOpQvB14PYCVJ8_tHLjNCkOqqrov3N-1UMFlYRzFQUVRKMDhNUEtJR1ZXNkk4SzhGWS4u
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children between four and six years of age. Healthy. Have at least two active dentin carious lesions on the primary teeth meeting the International Caries Detection and Assessment System (ICDAS) score 5 or 6. Should not have periapical infection, root resorption or widening in the periodontal ligament space. Exclusion Criteria: Participants who have systemic or neurological diseases. Tooth abscess, pain on percussion, symptoms of pulpal involvement or mobility, Allergic to silver or any dental material to be used. Unable to attend follow-up visits.
Facility Information:
Facility Name
Imam Abdulrahman Bin Faisal University
City
Dammam
State/Province
Eastern Province
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khalood S Bahammam
Phone
0546128448
Email
khulod.s.b@gmail.com
First Name & Middle Initial & Last Name & Degree
Yasmeen Y Muazen
Phone
0594733611
Email
yas.muazen@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Clinical and Laboratory Assessments of Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Caries Among Children and Parental Satisfaction

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