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Child Discomfort and Parental Acceptability of Silver Diamine Fluoride and Alternative Restorative Treatment

Child Discomfort and Parental Acceptability of Silver Diamine Fluoride and Alternative Restorative Treatment: a Randomized Controlled Clinical Trial

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04654624
Enrollment
80
Registered
2020-12-04
Start date
2018-10-12
Completion date
2019-10-30
Last updated
2020-12-04

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

Conditions

Dental Caries, Child Discomfort

Brief summary

The aim of the current study was to compare pain perception of young children treated with SDF and ART, as well as their parents' acceptability of both modalities.

Detailed description

Eighty, 3-8-years-old children, having at least one deciduous asymptomatic tooth with active caries were randomly assigned into 2 groups; SDF for caries arresting in the test group, and ART for caries removal in the control group.

Interventions

DRUGSDF

Steps of SDF 38% application were carried out following the manufacturer's instructions. Eligible primary carious teeth were first dried and isolated using cotton rolls and gauze. Adjacent soft tissues were isolated using petrolleum gelly in order to prevent any irritation or staining from SDF that was directly placed into the carious lesion using a microbrush, allowed to absorb for 2 minutes, then dried with air. Parents were instructed that children should not eat for one hour after treatment. The second application was done after 6 months.

DRUGART

Steps of ART caries removal were carried out following the Frencken et al. criteria where the cavity opening was widened using the tip of a dental hatchet. The carious dentin was then removed using a spoon excavator starting at the enamel-dentin junction, unsupported enamel was removed using the hatchet, and finally the cavity was cleaned using a wet cotton pellet and dried. After complete removal of infected dentin, the cavity walls and floor were conditioned for 10 seconds, washed and dried with cotton pellets, then restored with chemically cured glass ionomer cement that was applied under finger pressure, then coated with petroleum jelly.

Sponsors

Alexandria University
CollaboratorOTHER
Princess Nourah Bint Abdulrahman University
CollaboratorOTHER
Nourhan M.Aly
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No

Inclusion criteria

* Negative and definitely negative behavior according to Frankl's behavior rating scale. * Having at least one deciduous asymptomatic tooth with active caries, as defined by the International Caries Detection and Assessment System; ICDAS II scores 4, 5, 6.

Exclusion criteria

* Children who suffered from silver allergy, oral ulcerations, pulpal infections and whose parents needed immediate permanent restorations.

Design outcomes

Primary

MeasureTime frameDescription
Pain perception6 monthsPain reaction was assessed using the Sound, Eye, Motor scale (SEM) according to Wright et al. criteria. It is an objective method for pain assessment, where the child's level of anxiety was evaluated according to three types of observations. The score in each category ranged from one (no pain) to four (intense pain). A lower score represents less physical reaction to the procedure than does a higher value. Time of treatment was recorded using a stopwatch.

Secondary

MeasureTime frameDescription
Parents' acceptability of the treatment modality2 weeksIt was assessed using a 5-likert scale, self-administered questionnaire, specifically designed for the current study.

Countries

Egypt

Outcome results

None listed

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