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Completed

NCT Number: NCT05255913

Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries

Aim of the study: To evaluate and compare the clinical cariostatic efficacy of NSF with 38% SDF solution after sex and twelve months in arresting ECC lesions.

The Null hypothesis will be that no statistically significant difference will be detected between the two groups in the arrest of carious lesions in children with ECC.

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Key information

Conditions

Early Childhood Caries

Age range

2 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children younger than 4 years old.
  • The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II)
  • Completion of an informed consent to participate in the study.

Exclusion criteria

  • Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess, obvious discoloration of the tooth and premature hypermobility.
  • Parental refusal to participate in the study.
  • Allergy or sensitivity to silver or any of the materials included in the study.

Treatment and study plan

Nanosilver

Drug

preventive material for arresting caries

Silver diamine fluoride

Drug

preventive material for arresting caries

Primary outcomes

  1. caries arrest

    Time frame: 6 months and 1 year

    percentage of arresting caries in primary teeth

Secondary outcomes

  1. Comparing parental satisfaction and adverse effects with interventions

    Time frame: 6 months

    assessed by a self-rated questionnaire with responses on a 4-point Likert scale ranging from very satisfied, satisfied, unsatisfied, to very unsatisfied - Parents were also asked about adverse effects

  2. Evaluating oral health related quality of life of children and their families.

    Time frame: 6 months and 1 year

    by using the Arabic version of the Early Childhood Oral Health Impact Scale (A-ECOHIS)

  3. Assessing caries increment on remaining teeth in the oral cavity other than the tooth/ teeth receiving the preventive agent

    Time frame: 6 months and 1 year

    caries increment which is the number of new caries lesions developed over the study period detected using dmfs (change in dmfs score)

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries (a Randomized Clinical Trial)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 25, 2022
Registry last updated
Sep 26, 2023

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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