Effect of Application Time of 38% Silver Diamine Fluoride Solution on Arresting Dental Caries in Preschool Childre

The University of Hong Kong (HKU)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Early Childhood Caries

Treatments: Other: 3-second SDF application; Other: 15-second SDF application; Other: 60-second SDF application; Other: 5-second SDF application; Other: 30-second SDF application; Other: 180-second SDF application; Other: 45-second SDF application; Other: 10-second SDF application; Other: 120-second SDF application

Study type: Interventional

Funder types: Other

Identifiers

NCT04655430

HKU20201127

Details and patient eligibility

About

To determine the optimal application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Full description

Methods: The randomized double blinded clinical trial will recruit 414 healthy kindergarten children aged 3-5 years old with caries and with parental consent. The sample size is sufficient for the appropriate statistical analyses. The children will receive 0.004 mL 38% SDF (typical amount applied per manufacturer's instructions) to treat each caries lesion. The children will be classified into high and low caries rates and equably allocated into nine groups of SDF application time: 3, 5, 15, 30, 45, 60, 120 and 180 seconds. The children will be followed up for 6-months in their kindergartens. Clinical examinations after 6-months will be conducted to assess whether the caries is arrested. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and 6-months follow-up. The examiner, the children and the children's parents will be blind to the treatment allocation. The analysis will determine the significance of differences between the means of arrested caries at the various follow-ups; and Cochran-Armitage test will be used to evaluate the exposure (SDF-application time) to response relationship.

Significance: This study will help determine the optimal application time in SDF treatment. The study provides an evidence-based protocol for the use of silver diamine fluoride to arrest tooth decay in primary teeth of young children.

Enrollment: 600 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

(a) 3-5 year old children attending the first to the third year of kindergarten; (b) free from any systemic conditions and generally healthy; (c) parents sign informed consent (d) having at least 1 tooth with cavitated dentine carious lesion.

Exclusion criteria

• uncooperative and difficult to manage, have major systemic diseases such as porphyria, or are on long-term medication such as anti-epileptic drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 9 patient groups

3-second SDF application

Experimental group

Description:

3-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Treatment:

Other: 3-second SDF application

5-second SDF application

Experimental group

Description:

5-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Treatment:

Other: 5-second SDF application

10-second SDF application

Experimental group

Description:

10-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Treatment:

Other: 10-second SDF application

15-second SDF application

Experimental group

Description:

15-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Treatment:

Other: 15-second SDF application

30-second SDF application

Experimental group

Description:

30-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Treatment:

Other: 30-second SDF application

45-second SDF application

Experimental group

Description:

45-second application time of silver diamine fluoride (38% SDF) in arresting tooth decay (dental caries) in the primary teeth of preschool children.

Treatment:

Other: 45-second SDF application

60-second SDF application

Experimental group

Description:

60-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Treatment:

Other: 60-second SDF application

120-second SDF application

Experimental group

Description:

120-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Treatment:

Other: 120-second SDF application

180-second application time

Experimental group

Description:

180-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.

Treatment:

Other: 180-second SDF application