Silver Diamine Fluoride: A Randomized Controlled Trial on Its Effectiveness As A Caries Arresting Agent

NCT05008718 | Unknown

• 1 other identifier: SDF_UiTM
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the effectiveness of 38% Silver Diamine Fluoride (SDF) solution and to determine if it is superior to 5% NaF varnish in arresting carious lesions in the primary teeth of young children attending general dental clinic, Universiti Teknologi Mara. Hypothesis: Topical application of a 38% SDF solution on the primary teeth is superior to that of a 5% NaF varnish in arresting caries lesions in children at 3-months follow-up An intervention study is planned to compare the effectiveness of 38% SDF and 5% NaF in arresting caries lesions in primary teeth of 3-8 years old children attending general dental clinic, Universiti Teknologi Mara. The sample size needed (considering a 20% dropout rate) is 66 participants in each group. In addition, this study also aims to determine the demographic background, oral health-related habits, oral health-related quality of life of the participants and the parents acceptance on SDF treatment towards their child.

Conditions

Dental Caries; Quality of Life

Keywords

silver diamine fluoride; dental caries; effectiveness

Outcome Measures

Primary Outcomes (1)

• Caries arrest rate

  After SDF or NaF application, after 3 months assessment, smooth and hard tooth surface that could not be penetrated by probe easily will be classified as arrested lesion. Caries arrest rate will be calculated by the percentage of all arrested lesions over all treatment applied teeth in respective arm. DIAGNOdent reading will be taken for all lesions before and after treatment in which DIAGNOdent reading ≥ 16 is indicated more likely to develop dentin caries after 24 mos.

  3 months

Secondary Outcomes (1)

• Oral Health-Related Quality of Life

  3 months

Other Outcomes (1)

• Parental acceptance on SDF treatment

  3 months

Study Arms (2)

38% SDF group

ACTIVE COMPARATOR

38% silver diamine fluoride will be applied on caries lesions on deciduous teeth with a minimum score of 05 as defined by the International Caries Detection and Assessment System (ICDAS)

Other: 38% SDF group

5% NaF group

PLACEBO COMPARATOR

5% sodium fluoride will be applied on caries lesions on deciduous teeth with a minimum score of 05 as defined by the International Caries Detection and Assessment System (ICDAS)

Other: 5% NaF group

Interventions

38% SDF group OTHER

Participants will be randomized and will receive either 38% SDF treatment or 5% NaF treatment

38% SDF group

5% NaF group OTHER

Participants will be randomized and will receive either 38% SDF treatment or 5% NaF treatment

5% NaF group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Three to eight years old children. The reason for selecting children up to eight years old is because there are still patients aged seven to eight years old who presented with posterior deciduous teeth and upper lateral incisor deciduous teeth caries. Children below three years old are not included in order to obtain better cooperation from the participants.
• Children who are generally healthy, not medically compromised
• Children who have at least one active carious lesion on a deciduous tooth which include upper anterior teeth caries (c-c) with a minimum score of 05 as defined by the International Caries Detection and Assessment System (ICDAS)
• Provision of informed consent by the parent or guardian

You may not qualify if:

• Children with spontaneous or elicited pain from caries, tooth mobility, or signs of pulpal infection
• Children with severe medical conditions that would not allow management in the clinic
• Children with hereditary developmental defects, such as amelogenesis imperfecta
• Children with known allergies or sensitivities to dental materials, including silver diamine fluoride and sodium fluoride
• Inability to cooperate for silver diamine fluoride treatment or return for recall visits 3 months

Sponsors & Collaborators

• Universiti Teknologi Mara: lead

Study Sites (1)

Faculty of Dentistry, Universiti Teknologi Mara, Sg. Buloh Campus

Sungai Buloh, Selangor, 47000, Malaysia

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Intan Elliayana binti Mohammed

  Faculty of Dentistry, Universiti Teknologi Mara

  PRINCIPAL INVESTIGATOR

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: Principal Investigator, Dr

Study Record Dates

• First Submitted: August 14, 2021
• First Posted: August 17, 2021
• Study Start: June 21, 2022
• Primary Completion: February 10, 2023
• Study Completion: February 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)