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

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

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.

Study Overview

• Status: Completed
• Conditions: Early Childhood Caries
• Intervention / Treatment: Device: SDF; Device: NaF

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21514
    • Faculty Of Dentistry Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children ≤ 4 years old.
2. 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.
3. The Carious lesion has to be active according to Lesion Activity criteria of coronal caries of ICDAS II.
4. Parental consent for children's participation in the study.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SDF+NaF; Silver Diamine fluoride 38% (Applied biannually)+ Sodium Fluoride Varnish 5% (Applied every 3 months)	Device: SDF; Silver Diamine Fluoride 38% (Applied bianually); Device: NaF; Sodium Fluoride Varnish (5%) (Applied at baseline and after 3 months)
Active Comparator: SDF; Silver Diamine fluoride 38% (Applied biannually)	Device: SDF; Silver Diamine Fluoride 38% (Applied bianually)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries Increment (number of new caries lesions)	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).	6 months
Parental satisfaction with SDF application	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).	Baseline and at 6 months
Parental satisfaction with SDF application	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).	Baseline and at 6 months
Parental satisfaction with SDF application	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).	Baseline and at 6 months
Parental satisfaction with SDF application	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).	Baseline and at 6 months
Adverse effects reported after application of the interventions	Parents will be asked if their child experienced tooth or gum pain after application of the material. (Yes/No) Question	Baseline and at 6 months
Adverse effects reported after application of the interventions	The clinician will observe if gum swelling occurred after application of the material. (Yes/No) Question	Baseline and at 6 months
Adverse effects reported after application of the interventions	The clinician will observe if gum bleaching occurred after application of the material. (Yes/No) Question	Baseline and at 6 months
Adverse effects reported after application of the interventions	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	Baseline and at 6 months
Adverse effects reported after application of the interventions	Black staining of each lesion will be clinically observed and recorded (yes/no).	Baseline and at 6 months

Collaborators and Investigators

• Sponsor: Alexandria University
• Collaborators: Science, Technology & Innovation Funding Authority (STDF)
• Investigators: Principal Investigator: Enas B Abdellatif, Bachelor, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: ECC; SDF 38%; NaF 5%; preschoolers
• Other Study ID Numbers: 0272-07/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes