Clinical and Laboratory Assessments of Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Caries Among Children and Parental Satisfaction
- Conditions
- Caries Arrested
- Interventions
- Other: Silver Diamine Fluoride (SDF)
- Registration Number
- NCT04642846
- Lead Sponsor
- Khalood Saeed Bahammam
- 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:
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 155
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description one application of SDF Silver Diamine Fluoride (SDF) - two application of SDF one month apart Silver Diamine Fluoride (SDF) -
- Primary Outcome Measures
Name Time Method Effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries. 2 years Caries arresting rate: total number of arrested teeth/ total number of treated teeth.
- Secondary Outcome Measures
Name Time Method Clinical changes of dentinal lesion: in the hardness and softness. 2 years Changes in ICDAS score: post treatment change in carious lesion status.
Parents satisfaction 2 years 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
The antibacterial effect of the Silver Diamine Fluoride (SDF). 2 years by DNA extractions and performed the 16S rRNA sequencing
Trial Locations
- Locations (1)
Imam Abdulrahman Bin Faisal University
🇸🇦Dammam, Eastern Province, Saudi Arabia