Silver Diamine Fluoride Effectiveness Versus Atraumatic Restorative Treatment in Arresting ECC

NCT04514094 | Completed

• 1 other identifier: SDF Trials
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Childhood Caries

Outcome Measures

Primary Outcomes (1)

• change in clinical success/failure rate

  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

  at 6 and 12 months

Secondary Outcomes (2)

• Duration of the intervention visit

  During the procedure

• Patient Satisfaction

  after the 4th week

Study Arms (2)

Silver Diamine Fluoride

EXPERIMENTAL

* 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).

Drug: SDF

Atraumatic Restorative Treatment

ACTIVE COMPARATOR

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.

Procedure: ART

Interventions

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.

Also known as: Silver Diamine Fluoride

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.

Atraumatic Restorative Treatment

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

MeSH Terms

Interventions

silver diamine fluoride

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 14, 2020
• Study Start: January 1, 2018
• Primary Completion: April 8, 2019
• Study Completion: August 23, 2019
• Last Updated: August 14, 2020

Record last verified: 2020-08

Locations

EG (1)