RecruitingPhase 4NCT05872542

SDF Effectiveness on Arresting Caries in Children

Clinical Effectiveness of Silver Diamine Fluoride on Arresting Caries Lesions in Children


Sponsor

Umm Al-Qura University

Enrollment

60 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Purpose: To assess the clinical effectiveness of silver diamine fluoride (SDF) to control asymptomatic cavitated carious lesions compared to conventional glass ionomer restoration in preschool children.


Eligibility

Min Age: 5 YearsMax Age: 7 Years

Inclusion Criteria6

  • Healthy children without a history of serious systemic conditions necessitating chronic use of medications.
  • Children whose dental examination reveals at least one untreated asymptomatic cavitated carious lesion (ICDAS index: code 3-5) affecting primary molars.
  • Absence of former history of spontaneous pain from the offending tooth/teeth.
  • Teeth with normal vital pulp response when assessed using sensibility test and absence of any signs of irreversible pulpitis or necrotic pulp degeneration.
  • Absence of abnormal grade of tooth mobility, swelling, or tenderness on palpation or percussion.
  • Absence of any evidence of peri-radicular pathosis, or internal- or external resorption on radiographic examination.

Exclusion Criteria3

  • Patients with proven allergy to silver compounds or any component of dental materials to be applied.
  • Patients or guardians who refuse to participate in the study or had poor acceptance of SDF treatment.
  • Patients with ulcerative gingivitis or stomatitis.

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Interventions

DRUGSilver Diamine Fluoride (SDF)

Proper isolation of the operating field and removal of gross debris. Minimize contact with the gingiva and mucus membrane. Gentle dryness with compressed air. Dip and dab micro brush on the side of the dapper dish. Apply SDF to the affected surface (one drop/ appointment). Gentle dryness with compressed air for one minute. Remove excess SDF with gauze or cotton pellets. Continue to isolate the site for up to three minutes.

OTHERGlass Ionomer Restoration (GI)

Application of GI restoration necessitates removal of carious tissue using round bur rotating on low-speed contra and excavation of infected carious dentin. Followed by restoring the prepared cavity with glass ionomer restoration according to the manufacturer's instructions. The restoration will be checked for any high spots and occlusal interference (if any) will be corrected.

OTHERSodium fluoride varnish with nano-sliver particles (NaF-AgNP)

Proper isolation of the operating field and removal of gross debris. Minimize contact with the gingiva and mucus membrane. Gentle dryness with compressed air. Dip and dab micro brush on the side of the dapper dish. Apply NaF-AGNP to the affected surface (one drop/ appointment). Gentle dryness with compressed air for one minute. Continue to isolate the site for up to three minutes.


Locations(1)

UmmAlQuraUniversity

Mecca, Saudi Arabia

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NCT05872542


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