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Completed

NCT Number: NCT04514094

Silver Diamine Fluoride Effectiveness Versus Atraumatic Restorative Treatment in Arresting ECC

The study was conducted to evaluate the effectiveness of the biannual application of 38% silver diamine fluoride in arresting early childhood caries when compared to atraumatic restorative treatment.

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Key information

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

About this study

Owing to the virulent nature of early childhood caries (ECC) and its consequences if left untreated, immediate intervention is indicated to control the condition.

Barriers to intervention as young age, uncooperative patient behavior and lack of access to dental care are however, very common. The use of silver diamine fluoride as an anticaries agent is of growing popularity worldwide due to its promising results, safety of use, ease of application and relatively low cost. Further research is still required in order to provide evidence-based recommendations regarding the use of SDF in arresting early childhood caries. Purpose: To evaluate the effectiveness of biannual application of 38% silver diamine fluoride in arresting early childhood caries when compared to atraumatic restorative treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For children:
  • Healthy children.
  • Age range 2-5 years.
  • Informed consent (Appendix I)

For teeth:

  • Teeth with active dentin lesions corresponding to ICDAS II score 5 and 6.
  • Teeth having lesions that are considered active according to ICDAS II activity criteria for coronal primary caries.

Exclusion criteria

  • For children:
  • Children with systemic diseases.
  • Children with reported allergy to silver or to any other component in the materials used.
  • Children unable to return for recall visits.

For teeth:

  • Clinical or radiographic signs of pulpal involvement.(pain, abscess, sinus, obvious discoloration, premature hypermobility, internal or external root resorption).
  • Teeth with inactive lesions.

Treatment and study plan

SDF

Drug

SDF promotes enamel and dentin remineralization, as well as inhibit the growth of cariogenic bacteria. the Food and Drug Administration (FDA) approved SDF as a device for reducing tooth sensitivity in the USA.

Other names: Silver Diamine Fluoride

ART

Procedure

The ART technique involves caries excavation by hand instruments only with care to avoid pulp exposure. Such excavation is mainly from the periphery of the lesion to achieve a good seal of the restoration and minimize leakage. The tooth is then restored by glass ionomer cement.

Primary outcomes

  1. change in clinical success/failure rate

    Time frame: at 6 and 12 months

    Treated teeth in both groups will be evaluated for clinical success in each follow up appointment. The number of clinically successful/failed teeth will be recorded in

Secondary outcomes

  1. Duration of the intervention visit

    Time frame: During the procedure

    time spent during each intervention appointment was calculated in seconds

  2. Patient Satisfaction

    Time frame: after the 4th week

    using a 4-item, 5-level, Likert-scale questionnaire o assess feelings about the application procedure.

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Effectiveness of Silver Diamine Fluoride in Arresting Early Childhood Caries: Randomized Controlled Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2020
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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