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NCT Number: NCT05642494

Silver Diamine Fluoride(SDF) Versus SDF Combined With Sodium Fluoride Varnish in the Arrest of Early Childhood Caries

Early childhood caries (ECC) is the most common chronic childhood disease worldwide. Early restorative intervention may treat the disease but this is often difficult especially with uncooperative children so it may be left untreated. Remineralization of affected dentin using silver diamine fluoride (SDF) can arrest these lesions.

This trial aims to compare the effectiveness of 38% SDF solution versus 38% SDF solution with 5% sodium fluoride (NaF) varnish after six months in arresting ECC lesions.

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Key information

Conditions

Early Childhood Caries

Age range

1 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty Of Dentistry Alexandria University

Alexandria, 21514, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children ≤ 4 years old.
  • The presence of at least one carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II, Appendix 1, Table 1), detected by visual examination.
  • The Carious lesion has to be active according to Lesion Activity criteria of coronal caries of ICDAS II.
  • Parental consent for children's participation in the study.

Exclusion criteria

  • Children reporting spontaneous or elicited pain from caries, or showing any signs of pulpal infection, swelling and/or abscess.
  • Children showing a definite negative behavior (Score 1 Frankel's classification) during clinical examination.
  • Allergy or sensitivity to silver or any of the materials included in the study.

Treatment and study plan

SDF

Device

Silver Diamine Fluoride 38% (Applied bianually)

NaF

Device

Sodium Fluoride Varnish (5%) (Applied at baseline and after 3 months)

Primary outcomes

  1. The percentage of arrested carious lesions

    Time frame: 6 months

    For cavitated dentine caries lesions diagnosed as ICDAS code 5 or 6, visual inspection and tactile detection using a 0.5mm ball-ended Community Periodontal Index (CPI) probe without radiograph examination will be used for assessing caries activity according to Lesion Activity criteria of ICDAS II. If a wall or floor of the lesion is soft and easily penetrated by the probe using light force, then it will be diagnosed as active. A lesion with all surfaces being hard and smooth will be diagnosed as arrested caries .For a moderate caries lesion with no visible dentine (ICDAS code 3 or 4) at baseline, it will be classified as arrested caries at follow-up examination if the lesion did not progress to become a cavitated lesion with visible dentine (ICDAS code 5 or 6). Five tooth surfaces (buccal, lingual, mesial, distal and occlusal) will be examined in each posterior tooth and 4 tooth surfaces (labial, lingual, mesial and distal) in each anterior tooth.

Secondary outcomes

  1. Caries Increment (number of new caries lesions)

    Time frame: 6 months

    New caries lesions will be assessed through visual and tactile inspection using the World Health Organization (WHO) criteria for caries diagnosis. Full mouth examination will be conducted with the aid of a WHO CPI probe, and a disposable dental mirror. Five tooth surfaces (buccal, lingual, mesial, distal and occlusal) will be examined in each posterior tooth and 4 tooth surfaces (labial, lingual, mesial and distal) in each anterior tooth to assess the caries increment using the decayed, missing (due to caries), and filled primary tooth index per surface (dmfs).

  2. Parental satisfaction with SDF application

    Time frame: Baseline and at 6 months

    Parents will be asked If SDF Application is an easy process. Answers will be on a 5 point Likert scale (Strongly agree, Agree Neutral , Disagree, Strongly disagree).

  3. Parental satisfaction with SDF application

    Time frame: Baseline and at 6 months

    Parents will be asked if they are comfortable with discoloration of cavities after SDF placement, Answers will be on a 5 point Likert scale (Strongly agree, Agree Neutral , Disagree, Strongly disagree).

  4. Parental satisfaction with SDF application

    Time frame: Baseline and at 6 months

    Parents will be asked If SDF application was pain free for their child .Answers will be on a 5 point Likert scale (Strongly agree, Agree Neutral , Disagree, Strongly disagree).

  5. Parental satisfaction with SDF application

    Time frame: Baseline and at 6 months

    Parents will be asked if The taste of SDF was acceptable to their child.Answers will be on a 5 point Likert scale (Strongly agree, Agree Neutral , Disagree, Strongly disagree).

  6. Adverse effects reported after application of the interventions

    Time frame: Baseline and at 6 months

    Parents will be asked if their child experienced tooth or gum pain after application of the material.

    (Yes/No) Question

  7. Adverse effects reported after application of the interventions

    Time frame: Baseline and at 6 months

    The clinician will observe if gum swelling occurred after application of the material.

    (Yes/No) Question

  8. Adverse effects reported after application of the interventions

    Time frame: Baseline and at 6 months

    The clinician will observe if gum bleaching occurred after application of the material.

    (Yes/No) Question

  9. Adverse effects reported after application of the interventions

    Time frame: Baseline and at 6 months

    Systemic toxicity (nausea, vomiting, generalised discomfort) will be assesses by the clinician at the time of application and by asking the parents one week later.

    (Yes/No) Question

  10. Adverse effects reported after application of the interventions

    Time frame: Baseline and at 6 months

    Black staining of each lesion will be clinically observed and recorded (yes/no).

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Collaborators

  • Science,Technology & Innovation Funding Authority, Egypt

Registry information

Official study title

Comparison of the Effectiveness of Silver Diamine Fluoride Versus Silver Diamine Fluoride Combined With Sodium Fluoride Varnish in the Arrest of Early Childhood Caries: A Randomised Controlled Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 8, 2022
Registry last updated
Jul 19, 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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