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

NCT05642494 | Completed Phase 3 FDA Device

• 1 other identifier: 0272-07/2021
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Childhood Caries

Keywords

ECC; SDF 38%; NaF 5%; preschoolers

Outcome Measures

Primary Outcomes (1)

• The percentage of arrested carious lesions

  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.

  6 months

Secondary Outcomes (10)

• Caries Increment (number of new caries lesions)

  6 months

• Parental satisfaction with SDF application

  Baseline and at 6 months

• Parental satisfaction with SDF application

  Baseline and at 6 months

• Parental satisfaction with SDF application

  Baseline and at 6 months

• Parental satisfaction with SDF application

  Baseline and at 6 months

Study Arms (2)

SDF+NaF

EXPERIMENTAL

Silver Diamine fluoride 38% (Applied biannually)+ Sodium Fluoride Varnish 5% (Applied every 3 months)

Device: SDF; Device: NaF

SDF

ACTIVE COMPARATOR

Silver Diamine fluoride 38% (Applied biannually)

Device: SDF

Interventions

SDF DEVICE

Silver Diamine Fluoride 38% (Applied bianually)

SDF; SDF+NaF

NaF DEVICE

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

SDF+NaF

Eligibility Criteria

• Age: 1 Year - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead
• Science, Technology & Innovation Funding Authority (STDF): collaborator

Study Sites (1)

Faculty Of Dentistry Alexandria University

Alexandria, 21514, Egypt

Location

Related Publications (1)

• Abdellatif EB, El Kashlan MK, El Tantawi M. Silver diamine fluoride with sodium fluoride varnish versus silver diamine fluoride in arresting early childhood caries: a 6-months follow up of a randomized field trial. BMC Oral Health. 2023 Nov 17;23(1):875. doi: 10.1186/s12903-023-03597-5.

  PMID: 37978488 DERIVED

Study Officials

• Enas B Abdellatif, Bachelor

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Dental Public Health

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 8, 2022
• Study Start: March 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: April 30, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)