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

NCT04642846 | Unknown DMC FDA Device

• 1 other identifier: IAU
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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. 1.To assess the effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries.
2. 2.To assess the antibacterial effect of the Silver Diamine Fluoride (SDF).
3. 3.To assess parents' and children's satisfaction and acceptance.

Conditions

Caries Arrested

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical changes of dentinal lesion: in the hardness and softness.

  2 years

• The antibacterial effect of the Silver Diamine Fluoride (SDF).

  2 years

• Parents satisfaction

  2 years

Study Arms (2)

one application of SDF

EXPERIMENTAL

Other: Silver Diamine Fluoride (SDF)

two application of SDF one month apart

EXPERIMENTAL

Other: Silver Diamine Fluoride (SDF)

Interventions

Silver Diamine Fluoride (SDF) OTHER

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

one application of SDF; two application of SDF one month apart

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khalood Saeed Bahammam: lead

Study Sites (1)

Imam Abdulrahman Bin Faisal University

Dammam, Eastern Province, Saudi Arabia

RECRUITING

MeSH Terms

Interventions

silver diamine fluoride

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Intern at Imam Abdulrahman Bin Faisal University

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: November 24, 2020
• Study Start: November 21, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 24, 2020

Record last verified: 2020-11

Locations

SA (1)