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

• Sponsor: Khalood Saeed Bahammam (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04642846
• Collaborator: (none)
• Enrollment: 155
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21.3
• Patients Per Site Per Month: 7.3

Study Details

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Caries Arrested	Other: Silver Diamine Fluoride (SDF)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 155 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical and Laboratory Assessments of Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Caries Among Children and Parental Satisfaction
• Anticipated Study Start Date: Nov 21, 2020
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Clinical changes of dentinal lesion: in the hardness and softness. [2 years]

   Changes in ICDAS score: post treatment change in carious lesion status.

2. The antibacterial effect of the Silver Diamine Fluoride (SDF). [2 years]

   by DNA extractions and performed the 16S rRNA sequencing

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imam Abdulrahman Bin Faisal University	Dammam	Eastern Province	Saudi Arabia

Sponsors and Collaborators

• Khalood Saeed Bahammam

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Khalood Saeed Bahammam, Intern at Imam Abdulrahman Bin Faisal University, Imam Abdulrahman Bin Faisal University
• ClinicalTrials.gov Identifier: NCT04642846
• Other Study ID Numbers: IAU
• First Posted: Nov 24, 2020
• Last Update Posted: Nov 24, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Heart Arrest; Fluorides

Study Results

No Results Posted as of Nov 24, 2020