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

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

Early Childhood Caries
Oral Health Related Quality of Life

Treatments

Other: conventional composite resin restoration
Other: silver diamine fluoride

Study type

Interventional

Funder types

Other

Identifiers

NCT05337449
OHrQL in ECC treated with SDF

Details and patient eligibility

About

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

Full description

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.

Enrollment

40 estimated patients

Sex

All

Ages

3 to 5 years old

Volunteers

Accepts Healthy Volunteers

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.

Exclusion criteria

  • Unable to attend follow-up visits.
  • Refusal of participation.
  • Previously accessed teeth.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

silver diamine fluoride
Active Comparator group
Treatment:
Other: conventional composite resin restoration
Other: silver diamine fluoride
conventional composite resin restoration
Active Comparator group
Treatment:
Other: conventional composite resin restoration
Other: silver diamine fluoride

Trial contacts and locations

0

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Central trial contact

Gala Osman, BDS; Passant Nagi, PHD

Data sourced from clinicaltrials.gov

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