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

Early Childhood Caries Clinical Trial

Official title:

Effect of Application Time of 38% Silver Diamine Fluoride Solution on Arresting Dental Caries in Preschool Children: a Randomized Double Blinded Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04655430
• Other study ID #: HKU20201127
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2022
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Early Childhood Caries

Intervention

Other:
• 3-second SDF application
Dosage: 3-second 38% SDF solution application
• 5-second SDF application
Dosage: 5-second 38% SDF solution application
• 10-second SDF application
Dosage: 10-second 38% SDF solution application
• 15-second SDF application
Dosage: 15-second 38% SDF solution application
• 30-second SDF application
Dosage: 30-second 38% SDF solution application
• 45-second SDF application
Dosage: 45-second 38% SDF solution application
• 60-second SDF application
Dosage: 60-second 38% SDF solution application
• 120-second SDF application
Dosage: 120-second 38% SDF solution application
• 180-second SDF application
Dosage: 180-second 38% SDF solution application

Locations

Country	Name	City	State
Hong Kong	Local kindergartens	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The visible plaque index (VPI).	Two areas (buccal and lingual) of each of the six index teeth (55/51/63/71/75/83) will be examined and recorded (presence/absence) without visible plaque.	at 6-months follow-up
Primary	dmft index	The tooth discoloration, tooth status (decayed, missing or filled teeth teeth (dmft) index) and tooth mobility	at 6-months follow-up