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

Phase 3

Completed

• Conditions: Early Childhood Caries
• Interventions: Device: SDF; Device: NaF

• Registration Number: NCT05642494
• Lead Sponsor: Alexandria University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-12-08
• Primary Completion: 2023-03-30
• Study Completion: 2023-04-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SDF+NaF	SDF	Silver Diamine fluoride 38% (Applied biannually)+ Sodium Fluoride Varnish 5% (Applied every 3 months)
SDF+NaF	NaF	Silver Diamine fluoride 38% (Applied biannually)+ Sodium Fluoride Varnish 5% (Applied every 3 months)
SDF	SDF	Silver Diamine fluoride 38% (Applied biannually)

Primary Outcome Measures

Name	Time	Method
The percentage of arrested carious lesions	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 Outcome Measures

Name	Time	Method
Parental satisfaction with SDF application	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).
Caries Increment (number of new caries lesions)	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).
Adverse effects reported after application of the interventions	Baseline and at 6 months	Black staining of each lesion will be clinically observed and recorded (yes/no).

Trial Locations

Locations (1)

Faculty Of Dentistry Alexandria University; 🇪🇬 Alexandria, Egypt