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

Primary Purpose

Early Childhood Caries

Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
3-second SDF application
5-second SDF application
10-second SDF application
15-second SDF application
30-second SDF application
45-second SDF application
60-second SDF application
120-second SDF application
180-second SDF application
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Childhood Caries focused on measuring silver diamine fluoride, application time, preschool children, early childhood caries

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts 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.

Sites / Locations

  • Local kindergartens

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

3-second SDF application

5-second SDF application

10-second SDF application

15-second SDF application

30-second SDF application

45-second SDF application

60-second SDF application

120-second SDF application

180-second application time

Arm Description

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.
dmft index
The tooth discoloration, tooth status (decayed, missing or filled teeth teeth (dmft) index) and tooth mobility

Secondary Outcome Measures

Full Information

First Posted
November 30, 2020
Last Updated
December 8, 2022
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04655430
Brief Title
Effect of Application Time of 38% Silver Diamine Fluoride Solution on Arresting Dental Caries in Preschool Childre
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Childhood Caries
Keywords
silver diamine fluoride, application time, preschool children, early childhood caries

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3-second SDF application
Arm Type
Experimental
Arm Description
3-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Arm Title
5-second SDF application
Arm Type
Experimental
Arm Description
5-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Arm Title
10-second SDF application
Arm Type
Experimental
Arm Description
10-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Arm Title
15-second SDF application
Arm Type
Experimental
Arm Description
15-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Arm Title
30-second SDF application
Arm Type
Experimental
Arm Description
30-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Arm Title
45-second SDF application
Arm Type
Experimental
Arm Description
45-second application time of silver diamine fluoride (38% SDF) in arresting tooth decay (dental caries) in the primary teeth of preschool children.
Arm Title
60-second SDF application
Arm Type
Experimental
Arm Description
60-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Arm Title
120-second SDF application
Arm Type
Experimental
Arm Description
120-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Arm Title
180-second application time
Arm Type
Experimental
Arm Description
180-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Intervention Type
Other
Intervention Name(s)
3-second SDF application
Intervention Description
Dosage: 3-second 38% SDF solution application
Intervention Type
Other
Intervention Name(s)
5-second SDF application
Intervention Description
Dosage: 5-second 38% SDF solution application
Intervention Type
Other
Intervention Name(s)
10-second SDF application
Intervention Description
Dosage: 10-second 38% SDF solution application
Intervention Type
Other
Intervention Name(s)
15-second SDF application
Intervention Description
Dosage: 15-second 38% SDF solution application
Intervention Type
Other
Intervention Name(s)
30-second SDF application
Intervention Description
Dosage: 30-second 38% SDF solution application
Intervention Type
Other
Intervention Name(s)
45-second SDF application
Intervention Description
Dosage: 45-second 38% SDF solution application
Intervention Type
Other
Intervention Name(s)
60-second SDF application
Intervention Description
Dosage: 60-second 38% SDF solution application
Intervention Type
Other
Intervention Name(s)
120-second SDF application
Intervention Description
Dosage: 120-second 38% SDF solution application
Intervention Type
Other
Intervention Name(s)
180-second SDF application
Intervention Description
Dosage: 180-second 38% SDF solution application
Primary Outcome Measure Information:
Title
The visible plaque index (VPI).
Description
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.
Time Frame
at 6-months follow-up
Title
dmft index
Description
The tooth discoloration, tooth status (decayed, missing or filled teeth teeth (dmft) index) and tooth mobility
Time Frame
at 6-months follow-up

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Local kindergartens
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35292085
Citation
Yan IG, Zheng FM, Gao SS, Duangthip D, Lo ECM, Chu CH. Effect of application time of 38% silver diamine fluoride solution on arresting early childhood caries in preschool children: a randomised double-blinded controlled trial protocol. Trials. 2022 Mar 15;23(1):215. doi: 10.1186/s13063-022-06130-1.
Results Reference
derived

Learn more about this trial

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

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