Oral Health-Related Quality of Life of Early Childhood Caries Using Silver Diamine Fluoride Versus Drill and Fill Technique

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2023-12-30

Brief Summary

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The clinical trial aims to compare children's oral health-related quality of life (OHrQL) following caries arrest technique using SDF versus conventional drill and fill in the children with ECC

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Detailed Description

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Early childhood caries (ECC) has been an increasing issue in many countries and has become a significant health problem, especially in socially disadvantaged populations. ECC is a specific form of caries that occurs in children with primary teeth. ECC is characterized as "the early onset of caries in young children with often fast progression which can finally result in complete destruction of the primary dentition".

Management of cavitated carious lesions in primary teeth in very young children is time-consuming due to their lack of cooperation, so one of the alternative procedures could be performed with silver diamine fluoride (SDF), to its effectiveness in arresting the activity of carious lesions (cavitated and non-cavitated). It is easy to apply even outside dental offices, and relatively inexpensive solutions can be used particularly when compared to restorative intervention.

Conditions

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Oral Health Related Quality of Life Early Childhood Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

for both the intervention group and control group, the procedure and follow up will be done parallel to each other

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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silver diamine fluoride

Group Type ACTIVE_COMPARATOR

silver diamine fluoride

Intervention Type OTHER

silver diamine fluoride is a colorless with high PH topical fluoride solution of 38% weight/volume use for arresting early childhood caries

conventional composite resin restoration

Intervention Type OTHER

Dental composite resins are dental cement made of synthetic resins which were insoluble, of good tooth-like appearance, insensitive to dehydration, and easy to manipulate.

conventional composite resin restoration

Group Type ACTIVE_COMPARATOR

silver diamine fluoride

Intervention Type OTHER

silver diamine fluoride is a colorless with high PH topical fluoride solution of 38% weight/volume use for arresting early childhood caries

conventional composite resin restoration

Intervention Type OTHER

Dental composite resins are dental cement made of synthetic resins which were insoluble, of good tooth-like appearance, insensitive to dehydration, and easy to manipulate.

Interventions

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silver diamine fluoride

silver diamine fluoride is a colorless with high PH topical fluoride solution of 38% weight/volume use for arresting early childhood caries

Intervention Type OTHER

conventional composite resin restoration

Dental composite resins are dental cement made of synthetic resins which were insoluble, of good tooth-like appearance, insensitive to dehydration, and easy to manipulate.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children Aged 3 to 5 years, in good general health and medically within normal.
* The parents provided written informed consent.
* Carious vital primary molars with reversible pulpitis.
* Restorable teeth.
* Normal Radiographic findings.