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

Caries Arrested Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04642846
• Other study ID #: IAU
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2020
• Source: Imam Abdulrahman Bin Faisal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

1. To assess the effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries.

2. To assess the antibacterial effect of the Silver Diamine Fluoride (SDF).

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries Arrested
• Heart Arrest

Intervention

Other:
• Silver Diamine Fluoride (SDF)
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

Locations

Country	Name	City	State
Saudi Arabia	Imam Abdulrahman Bin Faisal University	Dammam	Eastern Province

Sponsors (1)

Lead Sponsor	Collaborator
Khalood Saeed Bahammam

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries.	Caries arresting rate: total number of arrested teeth/ total number of treated teeth.	2 years
Secondary	Clinical changes of dentinal lesion: in the hardness and softness.	Changes in ICDAS score: post treatment change in carious lesion status.	2 years
Secondary	The antibacterial effect of the Silver Diamine Fluoride (SDF).	by DNA extractions and performed the 16S rRNA sequencing	2 years
Secondary	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	2 years