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

NCT ID: NCT04642846

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-21

Study Completion Date

2022-09-01

Brief Summary

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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

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Conditions

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Caries Arrested

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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one application of SDF

Group Type EXPERIMENTAL

Silver Diamine Fluoride (SDF)

Intervention Type 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

two application of SDF one month apart

Group Type EXPERIMENTAL

Silver Diamine Fluoride (SDF)

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Khalood Saeed Bahammam

OTHER

Sponsor Role lead

Responsible Party

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Khalood Saeed Bahammam

Intern at Imam Abdulrahman Bin Faisal University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Imam Abdulrahman Bin Faisal University

Dammam, Eastern Province, Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Facility Contacts

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Khalood S Bahammam

Role: primary

Yasmeen Y Muazen

Role: backup

Other Identifiers

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IAU

Identifier Type: -

Identifier Source: org_study_id