Effectiveness of silver fluoride agents to arrest caries in children
| ISRCTN | ISRCTN14037606 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14037606 |
| Secondary identifying numbers | 4423 |
- Submission date
- 26/06/2022
- Registration date
- 11/07/2022
- Last edited
- 11/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Dental decay is a major frequent non-communicable form of disease that affects 60-90% children worldwide. More recently, Marcenes et al. reported untreated decay of the permanent teeth as the most prevalent condition world over and untreated decay of deciduous dentition 10th most prevalent condition, in the Global Burden of Disease Study, 2010. Untreated dental caries can adversely affect children’s quality of life and result in severe consequences including risk of dental sepsis. A significant association has also been reported between untreated decay and low body mass.
Although, the effectiveness of silver diamine fluoride is proven, but one of the disadvantages of using SDF in the black discoloration. on the other hand, it's well known by now that nano silver doesn't cause this disadvantage, Also, previous studies have used subjective measures to detect the cariostatic efficacy of SDF and NSF. The aim of this study was to evaluate the cariostatic effectiveness of silver diamine fluoride in comparison to nano-silver fluoride in children using Reveal Fluorescence Dental loupes (Designs for Vision, USA).
Who can participate?
Children aged 6-9 years old with untreated cavitated dental caries
What does the study involve?
The participants' primary molars will be randomly allocated to one of the two treatments: silver diamine fluoride or Nano-silver fluoride applied using a micro applicator brush for at least 1 minute. Then, petroleum gel will be applied to the same molar. Participants will be followed up for 3 months
What are the possible benefits and risks of participating?
Children will receive dietary advice and brushing instructions at the start of the study. Brushing instructions will include tooth-brushing three times a day using a conventional toothbrush and toothpaste containing a fluoride concentration of 1,000 ppm or more which will be provided for all participating children at no cost. Furthermore, the patients will be referred to the pediatric dentistry department at the University of Damascus for those participants with additional dental needs. There are no registered allergic reactions to the used materials, but the researchers will avoid including children who have experienced allergic reactions with either silver. They will also never use an amount close to the maximum dose of the products to avoid any health effects.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
January 2021 to December 2022
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Zuhair Al-Nerabieah
Zuhairmajid@gmail.com
Contact information
Principal Investigator
Mazzeh Street
PO Box 30621
Damascus
-
Syria
 ORCID ID |
0000-0003-1843-1776 |
|---|---|
| Phone | +963 969960118 |
| zuhairmajid@gmail.com |
Study information
| Study design | Single-center Interventional double-blinded randomized controlled trial with a split-mouth design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Detection of the cariostatic efficacy of silver diamine fluoride and nano-silver fluoride using reveal fluorescence dental loupes in children |
| Study acronym | SDF NSG |
| Study hypothesis | Silver diamine fluoride will arrest cavitated caries in primary molars more than nano-silver fluoride |
| Ethics approval(s) | Approved 12/01/2021, Ethics scientific committee at Damascus University (Mazzeh Street, PO Box 30621, Damascus, Syria; +963 (11) 339 23223; drsalloum74@hotmail.com), ref: 4423 |
| Condition | Treatment of cavitated carious lesions in primary molars in children |
| Intervention | Eligible teeth with cavitated carious lesion in preschool children will be randomly divided into 2 groups: Silver diamine fluoride, arm 1 Nano-Silver Fluoride biologically synthesized, arm 2 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. |
| Intervention type | Mixed |
| Primary outcome measure | Caries Arrest will be measured using Reveal Fluorescence Dental loupes at (T0) Baseline and re-evaluated at (T1) : 3 weeks after applying topical agents. and (T2): 3 months after applying topical agents |
| Secondary outcome measures | Patient discomfort will be assessed using Wong-Baker Faces scale, It will be assessed immediately after the sequence of treatments have been performed. |
| Overall study start date | 12/01/2021 |
| Overall study end date | 15/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | 1. Have not received antibiotic therapy in the past month before sampling. 2. Good oral hygiene. 3. Co-operative patients approving the trial. 4. 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 ) 5. Absence of spontaneous pain; negative sensitivity to percussion |
| Participant 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. |
| Recruitment start date | 15/12/2021 |
| Recruitment end date | 15/09/2022 |
Locations
Countries of recruitment
- Syria
Study participating centre
Faculty of Dentistry
Mazzeh Street
PO Box 30621
Damascus
0000
Syria
Sponsor information
University/education
Mazzeh Street
PO Box 30621
Damascus
-
Syria
| Phone | +963 (11) 339 23223 |
|---|---|
| ap.srd@damascusuniversity.edu.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 15/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication about the cariostatic efficacy of SDF and Nano-silver fluoride in children in BMC Oral Health. The study protocol and statistical data plan will be available upon request in Arabic. Both will be published after trial registration in a high-impact factor journal. |
| IPD sharing plan | The original data, along with the codebook and analysis scripts, will be stored in a non-publicly available repository at Damascus University. The data will consist of csv sheets with the data of the patients and R analysis scripts. The dataset will be called dataset and the dataset generated by the research, including also preprints and technical reports, will be called dataverse. The dataverse corresponding to this investigation will receive a digital object identifier (DOI). The citation has seven components. Five are human-readable: the author(s), title, year, data repository (or distributor), and version number. Two components are machine-readable: the DOI and the universal numeric fingerprint (UNF). The data generated will be de-identified using R's randomizeR package, removing all personal information. The naming convention for the archives will be date in yyyymmdd-version-identifier.extension format. The use of spaces will be avoided, being replaced by -. The original anonymized data will be published in the Mendeley data repository with restricted access once the data cleaning and exploratory analysis stage is completed. The data will be made public at the time of sending the final report to a peer-reviewed journal, with its DOI corresponding to the data associated with the research. The data will be embargoed until the final report is accepted, at which time it will become publicly available. No access restrictions will be applied to the data once the final project report has been accepted. |
Editorial Notes
11/07/2022: Trial's existence confirmed by University of Damascus.
