Effectiveness of SDF With Different Post-treatment Protocols in Arresting Dental Caries

The Effectiveness of Silver Diamine Fluoride Treatment With Different Post-treatment Protocols in Arresting Dental Caries in Primary Teeth of Preschool Children

To compare the effectiveness of the semi-annual application of 38% SDF with two post-treatment protocols in arresting dental caries in preschool children

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Caries
• Intervention / Treatment: Drug: 38% SDF treatment; Behavioral: rinse mouth immediately after SDF treatment; Behavioral: not to rinse for at least 30 minutes after SDF treatment

Detailed Description

Methods: The randomized double blinded clinical trial will recruit 254 healthy kindergarten children aged 3-5 years old with caries and with parental consent. All the tooth surfaces with carious lesions will receive the semi-annual application of 38% SDF solution. After the treatment, children will be allocated to two groups by an independent research assistant. Two post-treatment protocols are as follows.

Group A - Children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children.

Group B - Children are instructed not to eat and drink for at least 30 minutes. 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 12-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.

Significance: This study will help determine the optimal post-op treatment 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.

• Study Type: Interventional
• Enrollment (Anticipated): 254
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chun Hung Chu, PhD; Phone Number: (+852)28590287; Email: chchu@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. are uncooperative to accept oral examination or treatment;
2. have a significant systematic disease or long-term medications;
3. have abnormal dentition.
4. Teeth having signs or symptoms of irreversible pulpitis and non-vitality will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A- immediately rinse mouth; Children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children.	Drug: 38% SDF treatment; Children with active caries will receive 38% silver diamine fluoride treatment; Behavioral: rinse mouth immediately after SDF treatment; After receiving 38% silver diamine fluoride treatment, Children will be asked to rinse their mouths immediately.
Experimental: Group B- not to rinse for at least 30 minutes; Children are instructed not to eat and drink for at least 30 minutes.	Drug: 38% SDF treatment; Children with active caries will receive 38% silver diamine fluoride treatment; Behavioral: not to rinse for at least 30 minutes after SDF treatment; After receiving 38% silver diamine fluoride treatment, Children will be asked not to rinse their mouths for at least 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries status	The proportion of the soft (active) carious tooth lesion surfaces that harden (arrested) at 12 months of follow-up will be measured	at 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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) the status of visible plaque.	at 12-month follow-up
dmft index	The caries experience will be recorded to assess the caries increment by using dmft index at baseline and 12 months later	at 12-month follow-up

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: preschool children; silver diamine fluoride; dental caries
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: HKU20221001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No