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Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish

Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish: A Randomized Clinical Trial

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03557996
Enrollment
42
Registered
2018-06-15
Start date
2018-12-01
Completion date
2020-06-01
Last updated
2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries in Children

Brief summary

To assess discoloration of carious primary teeth after application of silver diamine fluoride versus sodium fluoride varnish.

Detailed description

The American Academy of Pediatric Dentistry's (AAPD) guidelines (2017) stated that Silver diamine fluoride (SDF) is a brush-on liquid that arrest 87.7% of dental caries lesions. The success rate is similar for restorations placed under GA. One of the most exciting aspects of SDF is the 67±4% decrease in new lesions on untreated surfaces, achieved simply by treating active lesions .This is not the same as incidence of any new lesions (elaborated above for treatment under GA), however the relation warrants further investigation. Benefit to the patient * No pain and infection. * Enhance child cooperation. * Enhance better patient compliance. * Decrease cost of dental treatment and may eliminate the need for General Anesthesia. Benefit to the dentist * Develop an effective fast easy method to arrest the caries by using SDF. * Ease of dental treatment. * Better cooperation with the child. * The procedure is simple. * Inexpensive and non-invasive. * It does not require expensive equipment or support infrastructure, such as pipe water or electricity. Benefit to the population * Reduce the harmful impact of oral health problems in preschool children from low income families. * SDF can be considered a user-friendly material for use in dental clinics as well as remote areas, schools or deprived communities. Children aged 2-5 years can benefit from the use of SDF, an easy anticaries treatment. Furthermore, children in this age group may benefit from delayed dental treatment and overall caries arrest, thus reducing potential pain and infection, expensive future emergency room visits, the need for general anesthesia or traumatic dental experiences on uncooperative children.

Interventions

DRUGSilver Diamine Fluoride

SDF will be applied with a brush

NaF will be applied with a brush

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

double (participant-outcome assessor)

Intervention model description

patient will receive either silver diamine fluoride or sodium fluoride varnish

Eligibility

Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
Yes

Inclusion criteria

1. Children with carious primary teeth before eruption of permanent teeth 2. High caries risk patients with anterior or posterior carious lesions 3. Uncooperative children without access to or with difficulty accessing dental care.

Exclusion criteria

1. Children with spontaneous or elicited pain from caries 2. Tooth mobility 3. Signs of pulpal infection 4. Severe medical conditions that would not allow management in the clinic

Design outcomes

Primary

MeasureTime frameDescription
Discoloration12 monthsDiscoloration will be assessed by questioning the patient and/or the guardian.binary (yes or no)

Secondary

MeasureTime frameDescription
Investigator reported discoloration12 monthsInvestigator will report the discoloration occurred to treated teeth (yellow, brown, black) Visual examination
Timing of discoloration12 monthsVisual examination at follow up
Caries arrest (dentine texture)12 monthsCaries arrest will be assessed through tactile examination (Soft or hard) Tactile examination
Postoperative Pain: Questioning the patient12 monthsQuestioning the patient and/or the parentBinary (yes or No)
Parental satisfaction: Questioning the parent12 monthsQuestioning the parent

Countries

Egypt

Contacts

Primary ContactYousra M Abdel Rehim, MSc
yousra.mohamed@dentistry.cu.edu.eg01273335144
Backup ContactFatma KI Abdelgawad, Lecturer
fatmadent@hotmail.com01006753265

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026