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

NCT05655286 | Completed DMC

• 1 other identifier: HKU20221001
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Caries

Keywords

dental caries; preschool children; silver diamine fluoride

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A- immediately rinse mouth

EXPERIMENTAL

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; Behavioral: rinse mouth immediately after SDF treatment

Group B- not to rinse for at least 30 minutes

EXPERIMENTAL

Children are instructed not to eat and drink for at least 30 minutes.

Drug: 38% SDF treatment; Behavioral: not to rinse for at least 30 minutes after SDF treatment

Interventions

38% SDF treatment DRUG

Children with active caries will receive 38% silver diamine fluoride treatment

Group A- immediately rinse mouth; Group B- not to rinse for at least 30 minutes

not to rinse for at least 30 minutes after SDF treatment BEHAVIORAL

After receiving 38% silver diamine fluoride treatment, Children will be asked not to rinse their mouths for at least 30 minutes.

Group B- not to rinse for at least 30 minutes

rinse mouth immediately after SDF treatment BEHAVIORAL

After receiving 38% silver diamine fluoride treatment, Children will be asked to rinse their mouths immediately.

Group A- immediately rinse mouth

Eligibility Criteria

• Age: 3 Years - 4 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The university of Hong Kong

Hong Kong, China

Location

Related Publications (1)

• Sun IG, Duangthip D, Lo ECM, Chu CH. The Caries-Arrest Effectiveness of Silver Diamine Fluoride Treatment with Different Post-Treatment Instructions in Preschool Children: A Study Protocol for a Randomized Controlled Trial. Dent J (Basel). 2023 Jun 5;11(6):145. doi: 10.3390/dj11060145.

  PMID: 37366668 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 19, 2022
• Study Start: January 1, 2023
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)