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

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.

Study Overview

• Status: Unknown
• Conditions: Caries Arrested
• Intervention / Treatment: Other: Silver Diamine Fluoride (SDF)

• Study Type: Interventional
• Enrollment (Anticipated): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Eastern Province
    • Dammam, Eastern Province, Saudi Arabia
      • Recruiting
      • Imam Abdulrahman Bin Faisal University
      • Contact: Khalood S Bahammam; Phone Number: 0546128448; Email: khulod.s.b@gmail.com
      • Contact: Yasmeen Y Muazen; Phone Number: 0594733611; Email: yas.muazen@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: one application of SDF	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
Experimental: two application of SDF one month apart	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical changes of dentinal lesion: in the hardness and softness.	Changes in ICDAS score: post treatment change in carious lesion status.	2 years
The antibacterial effect of the Silver Diamine Fluoride (SDF).	by DNA extractions and performed the 16S rRNA sequencing	2 years
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

Collaborators and Investigators

• Sponsor: Khalood Saeed Bahammam

Study record dates

Study Major Dates

• Study Start (Anticipated): November 21, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: November 21, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 21, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: IAU (Istanbul Arel University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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