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Trial registered on ANZCTR


Registration number
ACTRN12618001865202
Ethics application status
Approved
Date submitted
13/11/2018
Date registered
16/11/2018
Date last updated
17/05/2019
Date data sharing statement initially provided
16/11/2018
Date results information initially provided
19/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical agents for dental caries arrest in preschool children
Scientific title
Evaluation of the Effectiveness of Silver Diamine Fluoride Compared with Nano-Silver Fluoride for Dental Carious Lesions Arrest in Preschool Children
Secondary ID [1] 296581 0
None
Universal Trial Number (UTN)
U1111-1223-8678
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental caries 310388 0
Condition category
Condition code
Oral and Gastrointestinal 309105 309105 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 312894 0
Treatment: Drugs
Comparator / control treatment
Sterilized water
Control group
Placebo

Outcomes
Primary outcome [1] 308080 0
Caries Arrest
The measure will be done by blinded investigators using international caries detection and assessment system II (ICDAS II) criteria for diagnosing active and arrested caries.
Timepoint [1] 308080 0
(T0) Baseline and re-evaluate in two time interval stages:
(T1) : 3 weeks after applying topical agents
(T2): 3 months after applying topical agents
Secondary outcome [1] 353896 0
Patient discomfort
Patient discomfort will be assessed using Wong-Baker Faces scale
Timepoint [1] 353896 0
It will be assessed immediately after the sequence of treatments have been performed.

Eligibility
Key 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
Minimum age
24 Months
Maximum age
72 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation for children will be done using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size was calculated using g-power 3.1 software. The significance level was set at 0.05 and the power of the study was set to be 0.80.
Based on a one-way Anova test, it was estimated that 80 patients were required to demonstrate an effect size (0.4) in the average proportion of arrested caries.
Sample size will be raised to 100 patients to avoid the negative effect of the possible drop rate.

Statistical analyses will be performed using the statistical software SPSS for Windows (version 25.0, SPSS Inc.,Chicago,IL,USA).

- The normality of distribution of the date will be verified by Kolmogorov-Smirnov normality test.
- If the data were normally distributed, One-way Anova test will be applied. Deviations from baseline will be tested for significance with the Bonferroni post hoc test.
- if the data were not normally distributed, kruskal wallis test will be applied. Deviations from baseline will be tested for significance with the Wilcoxon Signed Rank Matched Pairs Test.
- Interrater reliability will be tested using Cohen's Kappa measure.
- The level of significance will be set at 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21018 0
Syrian Arab Republic
State/province [1] 21018 0
Damascus

Funding & Sponsors
Funding source category [1] 301161 0
University
Name [1] 301161 0
Damascus University
Address [1] 301161 0
Dental College, Damascus University, Al-Mazzeh St., Damascus, Syria.
Country [1] 301161 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Dental College, Damascus University, Al-Mazzeh St., Damascus, Syria.
Country
Syrian Arab Republic
Secondary sponsor category [1] 300782 0
None
Name [1] 300782 0
None
Address [1] 300782 0
None
Country [1] 300782 0
Other collaborator category [1] 280420 0
University
Name [1] 280420 0
Syrian Private University
Address [1] 280420 0
faculty of pharmacy, Syrian private University, Al-Mazzeh St., Damascus.
Country [1] 280420 0
Syrian Arab Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301906 0
Ethical and Scientific Committee of dental research
Ethics committee address [1] 301906 0
Dental College, Damascus University, Al-Mazzeh Street, Damascus, Syria
Ethics committee country [1] 301906 0
Syrian Arab Republic
Date submitted for ethics approval [1] 301906 0
20/04/2018
Approval date [1] 301906 0
21/05/2018
Ethics approval number [1] 301906 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88510 0
Dr Zuhair AlNerabieah
Address 88510 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 88510 0
Syrian Arab Republic
Phone 88510 0
+963969960118
Fax 88510 0
Email 88510 0
Zuhairmajid@gmail.com
Contact person for public queries
Name 88511 0
Dr Zuhair AlNerabieah
Address 88511 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 88511 0
Syrian Arab Republic
Phone 88511 0
+963969960118
Fax 88511 0
Email 88511 0
Zuhairmajid@gmail.com
Contact person for scientific queries
Name 88512 0
Dr Zuhair AlNerabieah
Address 88512 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 88512 0
Syrian Arab Republic
Phone 88512 0
+963969960118
Fax 88512 0
Email 88512 0
Zuhairmajid@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary