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Topical agents for dental caries arrest in preschool children

Evaluation of the Effectiveness of Silver Diamine Fluoride Compared with Nano-Silver Fluoride for Dental Carious Lesions Arrest in Preschool Children

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001865202
Enrollment
100
Registered
2018-11-16
Start date
2018-11-20
Completion date
2018-12-20
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to assess the effectiveness of Nano-Silver Fluoride that were synthesized by two different methods ( Chemical and Biological) compared with silver diamine fluoride for arresting cavitated carious lesion in preschool children. Randomized controlled clinical trial The null hypothesis tested is that topical application of Nano silver fluoride solutions is not effective in arresting dental carious lesions.

Interventions

Eligible teeth with cavitated carious lesion in preschool children will be randomly divided into 4 groups: Sterilized water, arm 1 Silver diamine fluoride, arm 2 Nano-Silver Fluoride chemically synthesized, arm 3 Nano-Silver Fluoride Biologically synthesized, arm 4 Each participant will be assigned to one treatment group to avoid the possible synergetic effect of the different agents. The affected tooth surface will be gently cleaned by a disposable micro-brush applicator for at least 30 secon

Eligible teeth with cavitated carious lesion in preschool children will be randomly divided into 4 groups: Sterilized water, arm 1 Silver diamine fluoride, arm 2 Nano-Silver Fluoride chemically synthesized, arm 3 Nano-Silver Fluoride Biologically synthesized, arm 4 Each participant will be assigned to one treatment group to avoid the possible synergetic effect of the different agents. The affected tooth surface will be gently cleaned by a disposable micro-brush applicator for at least 30 seconds and then dried with cotton gauze. The gingival tissue of the tooth will be protected with petroleum jelly. A new micro-brush applicator will be dipped into one of the agents and 3–4 mg will be applied to the lesion (1 drop treats 3 to 5 teeth). No rinse will be performed and the tooth surface will be covered with petroleum jelly. Kindergarten teachers will be notified that participants aren't allowed to eat or drink for an hour after the application. The application of all topical agents will be done by an experienced investigator and the intervention will be delivered in the kindergarten. A visual/tactile examination will be performed before and 21 days and 3 months after treatment to identify and assess lesions for caries activity

Sponsors

Damascus University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
24 Months to 72 Months
Healthy volunteers
No

Inclusion criteria

Inclusion Criteria of participants: 1. Have not received antibiotic therapy in the past month before sampling. 2. Good oral hygiene. 3. Co-operative patients approving the trial. Inclusion Criteria of teeth: 1. untreated cavitated active caries lesion with dentin exposed based on the ICDAS II (Code 5: dentin cavity easily visible with the naked eye where the surface of cavity feels soft or leathery on gentle probing ) 2. Absence of spontaneous pain; negative sensitivity to percussion

Exclusion criteria

1. Children weight less than 15 kg. 2. known sensitivity to silver or other heavy-metal ions 3. presence of any gingival or perioral ulceration or stomatitis or presence of a tooth abscess.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026