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

Alexandria University220 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

220

Conditions

Early Childhood Caries

Interventions

SDFDEVICE

Silver Diamine Fluoride 38% (Applied bianually)

NaFDEVICE

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

Eligibility

Sex: ALLMin age: 1 YearMax age: 4 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty Of Dentistry Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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).

Data from ClinicalTrials.gov

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