Silver Diamine Fluoride Effectiveness Versus Atraumatic Restorative Treatment in Arresting ECC

Hams Hamed Abdelrahman

Status: Completed

Conditions: Early Childhood Caries

Treatments: Procedure: ART; Drug: SDF

Study type: Interventional

Funder types: Other

Identifiers

NCT04514094

SDF Trials

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• For children:

  1. Healthy children.
  2. Age range 2-5 years.
  3. 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:

  1. Children with systemic diseases.
  2. Children with reported allergy to silver or to any other component in the materials used.
  3. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Silver Diamine Fluoride

Experimental group

Description:

* Gross debris will be removed with cotton pellets to allow better SDF contact with denatured dentin. * Cotton rolls will be used to protect surrounding gingival tissues and mucous membranes to avoid pigmentation or irritation. * Affected tooth surfaces will be dried with a gentle flow of air. * 1-2 drops only of SDF will be used for the whole visit. * SDF will then be directly applied to affected tooth surfaces only using a micro sponge brush. * At least one minute will be needed to allow drying of SDF. * Excess SDF will finally be removed with cotton rolls to minimize systemic absorption. * When possible, isolation will be continued for up to three minutes. * After 2-4 weeks: reapplication will be done only to lesions that do not appear arrested (dark and hard).

Treatment:

Drug: SDF

Atraumatic Restorative Treatment

Active Comparator group

Description:

Caries removal by hand instruments with care not to expose the pulp. * Maximum excavation from the periphery of lesions will be done, to minimize leakage at the restoration margins. * Cotton roll isolation will then be carried out. * Cavities will be restored by glass ionomer cement. * Hand pressure should be applied by a gloved and petroleum jelly coated finger, then, excess material will be removed.

Treatment:

Procedure: ART