Dental remineralization with a silver nanoparticle compound
| ISRCTN | ISRCTN18357873 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18357873 |
| Secondary identifying numbers | FESZ -CE/21-208-05 |
- Submission date
- 25/07/2024
- Registration date
- 19/08/2024
- Last edited
- 18/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Dental caries (tooth decay) is the most frequent oral disease in children. Silver diamine fluoride can prevent caries with the adverse effect of tissue pigmentation. The main of the present study is to evaluate the effectiveness of a compound of silver nanoparticles with a fluoride varnish to mineralize dentine affected by tooth decay.
Who can participate?
Healthy schoolchildren aged 6 to 9 years old with caries in primary molars (milk teeth)
What does the study involve?
Primary molars are distributed into two groups: Group A is treated with a compound based on silver nanoparticles and Group B with a silver diamine fluoride compound as a control treatment. All participants receive a clinical oral examination and radiographic diagnosis at the beginning of the study and the application of the treatments every 6 months for one and a half years.
What are the possible benefits and risks of participating?
The children participating in the study are included in an oral health program for diagnosis and preventive treatments and receive a painless and easy treatment to stop their caries lesions. There are minimal possible risks because the treatments are safe and carried out under safety measures by experienced pediatric dentists. The secondary effect of pigmentation of the cavities treated with diamine fluoride silver could be observed.
Where is the study run from?
Reforma Multidisciplinary Clinic of the Faculty of Superior Studies of Zaragoza (Mexico)
When is the study starting and how long is it expected to run for?
April 2021 to March 2024
Who is funding the study?
Universidad Nacional Autónoma de México (Mexico)
Who is the main contact?
Maria Lilia Adriana Juarez Lopez, marialiliajuarez_0403@comunidad.unam.mx, lilia.juarez@zaragoza.unam.mx
Contact information
Public, Scientific, Principal Investigator
Saturno 32
Mexico City
14370
Mexico
 ORCID ID |
0000-0001-6470-3168 |
|---|---|
| Phone | +52 (0)5554342362 |
| lilia.juarez@zaragoza.unam.mx |
Study information
| Study design | Non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | School |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effectiveness of remineralization with compound silver nanoparticles and fluoride varnish in caries lesions |
| Study objectives | Silver nanoparticle compound is a conservative treatment to stop the progression of dental caries |
| Ethics approval(s) |
Approved 29/07/2021, Research Committee of Faculty of High Studies of Zaragoza, Mexican National University (Campus 2 Batalla 5 de mayo S/N, Iztapalapa, 09230, Mexico; +52 (0)5556230724; div.posgrado.investigacion@zaragoza.unam.mx), ref: FESZ -CE/21-208-05 |
| Health condition(s) or problem(s) studied | Dental caries |
| Intervention | Primary molars were distributed into two groups: Group A was treated with a compound based on silver nanoparticles and Group B with silver diamine fluoride compound as control treatment. Laser fluorescence was used for evaluation, with follow-up examinations at 15 days, 6 and 12 months. Also, a clinical examination for the detection of active or arrest caries lesions was performed at baseline and 12 months. This study was conducted in a convenience sample of school children aged 6 to 9 years with at least two carious lesions in primary molars. The selected molars were assigned to each study group, taking care that both treatments were applied to one of the carious molars of the same patient. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Remineralization measured for each caries lesion using the Diagnodent pen test (laser fluorescence) and data will be recorded at baseline and after each application: 15 days, 6 and 12 months |
| Secondary outcome measures | The arrest of caries lesions measured by considering the texture and colour of the caries lesions by clinical inspection with the aid of a WHO probe to classify them as active or arrested lesions at baseline and 12 months |
| Overall study start date | 24/04/2021 |
| Completion date | 15/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 9 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Children with caries lesions 2. Children agree to participate in the study |
| Key exclusion criteria | 1. Children with general disease 2. Molars with non-reversible pulpitis, abscesses |
| Date of first enrolment | 26/08/2022 |
| Date of final enrolment | 30/10/2022 |
Locations
Countries of recruitment
- Mexico
Study participating centre
C.P. 57840
Ciudad Nezahualcóyotl
Estado de México
Mexico City
09230
Mexico
Sponsor information
University/education
Campus 2 Batalla 5 de mayo col ejercito de oriente
Mexico City
09230
Mexico
| Phone | +52 (0)5556230725 |
|---|---|
| div.posgrado.investigacion@zaragoza.unam.mx | |
| Website | https://www.zaragoza.unam.mx/ |
"ROR" |
https://ror.org/01tmp8f25 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Dirección General de Asuntos del Personal Académico, General Direction of Academic Staff Affairs, UNAM - Dirección General Asuntos del Personal, General Directorate of Academic Personal Affairs, DGAPA, UNAM, DGAPA
- Location
- Mexico
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during the current study will be stored in a non-public repository of the Mexican National University |
Editorial Notes
15/08/2024: Study's existence confirmed by the Zaragoza Faculty of Mexican National University.
