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

Primary Purpose

Dental Caries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
38% SDF treatment
not to rinse for at least 30 minutes after SDF treatment
rinse mouth immediately after SDF treatment
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring dental caries, preschool children, silver diamine fluoride

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 3-5 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 Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group A- immediately rinse mouth

    Group B- not to rinse for at least 30 minutes

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary 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) the status of visible plaque.
    dmft index
    The caries experience will be recorded to assess the caries increment by using dmft index at baseline and 12 months later

    Full Information

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

    Unique Protocol Identification Number
    NCT05655286
    Brief Title
    Effectiveness of SDF With Different Post-treatment Protocols in Arresting Dental Caries
    Official Title
    The Effectiveness of Silver Diamine Fluoride Treatment With Different Post-treatment Protocols in Arresting Dental Caries in Primary Teeth of Preschool Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries
    Keywords
    dental caries, preschool children, silver diamine fluoride

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    254 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A- immediately rinse mouth
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Group B- not to rinse for at least 30 minutes
    Arm Type
    Experimental
    Arm Description
    Children are instructed not to eat and drink for at least 30 minutes.
    Intervention Type
    Drug
    Intervention Name(s)
    38% SDF treatment
    Intervention Description
    Children with active caries will receive 38% silver diamine fluoride treatment
    Intervention Type
    Behavioral
    Intervention Name(s)
    not to rinse for at least 30 minutes after SDF treatment
    Intervention Description
    After receiving 38% silver diamine fluoride treatment, Children will be asked not to rinse their mouths for at least 30 minutes.
    Intervention Type
    Behavioral
    Intervention Name(s)
    rinse mouth immediately after SDF treatment
    Intervention Description
    After receiving 38% silver diamine fluoride treatment, Children will be asked to rinse their mouths immediately.
    Primary Outcome Measure Information:
    Title
    Caries status
    Description
    The proportion of the soft (active) carious tooth lesion surfaces that harden (arrested) at 12 months of follow-up will be measured
    Time Frame
    at 12-month follow-up
    Secondary 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) the status of visible plaque.
    Time Frame
    at 12-month follow-up
    Title
    dmft index
    Description
    The caries experience will be recorded to assess the caries increment by using dmft index at baseline and 12 months later
    Time Frame
    at 12-month 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: 3-5 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 Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chun Hung Chu, Phd
    Phone
    (+852)28590287
    Email
    chchu@hku.hk

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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