Does the application of fluoride varnishes during pregnancy induce changes in fluoride concentrations in the saliva of pregnant women?
| ISRCTN | ISRCTN10541688 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10541688 |
- Submission date
- 14/06/2022
- Registration date
- 29/06/2022
- Last edited
- 15/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
During pregnancy, there is a higher risk of getting oral diseases, like caries or periodontal disease. Likewise, certain oral diseases have been related to bad pregnancy outcomes (preeclampsia, preterm birth). A preventive program is necessary that allows pregnant women good control over their oral health and access to preventive methods. The aim of this study is to evaluate the differences in fluoride concentrations in the saliva of pregnant women after the use of three fluoride varnishes (Clinpro White Varnish 3M ESPE®, VOCO Profluorid Varnish®, and MI Varnish GC Tokio®).
Who can participate?
Healthy pregnant women between 16 and 31 weeks of gestation
What does the study involve?
Different questionnaires were used to collect information about sociodemographic background, hygienic habits, beliefs, and epidemiological indices, involving decayed, missing, and filled teeth scoring of those women who assisted in the preventive program between 2018 and 2019 that had already been set up in Clinica Odontológica Universitaria. In the first visit, we collected two samples of saliva (one before and one after the application of the fluoride varnish), and for further analysis, during the other visits (after 15, 30, and 45 days) we took one sample.
What are the possible benefits and risks of participating?
The main benefit pregnant woman can get from participating in the study is an improvement in their oral health and knowledge related to their oral health and their babies. There is no risk in participating.
Where is the study run from?
Clínica Odontológica Universitaria from Universidad de Murcia (Spain)
When is the study starting and how long is it expected to run for?
September 2018 to October 2022
Who is funding the study?
Universidad de Murcia (Spain)
Who is the main contact?
Miss Icíar Fernández Pizarro (Spain)
iciarfp@gmail.com
Contact information
Scientific
Universidad de Murcia
Departamento de Dermatología
Estomatología
Radiología y Medicina física
Av. Marqués de los Vélez
Murcia
30008
Spain
| Phone | +34 868888583 |
|---|---|
| iciar.fernandez@um.es |
Principal Investigator
Universidad de Murcia
Departamento de Dermatología
Estomatología
Radiología y Medicina física
Av. Marqués de los Vélez
Murcia
30008
Spain
 ORCID ID |
0000-0002-1523-9415 |
|---|---|
| Phone | +34 868888583 |
| yolandam@um.es |
Study information
| Study design | Longitudinal randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Scientific title | Fluoride varnish effects in fluoride concentration in saliva throughout pregnancy: Longitudinal Clinical Randomized Trial |
| Study objectives | The application of fluoride varnishes throughout pregnancy does not induce changes in fluoride concentrations in saliva in pregnant women |
| Ethics approval(s) | Approved 13/05/2019, Comité de Ética de Investigación (Research Ethics Commission) of Murcia University (Calle Santo Cristo 1, 30001, Murcia, Spain; +34 868 88 3614; comision.etica.investigacion@um.es), ref: 2265/2019 |
| Health condition(s) or problem(s) studied | Fluoride concentration in saliva in pregnant women |
| Intervention | Pregnant women come to the Preventive Program recommended by their general practitioners. In the first visit, we take a sample of saliva before any procedure, then an oral exploration is made during which Decay and Periodontal Indexes are registered. Then the women are randomly assigned to receive the different types of fluoride varnishes or none, and another sample of saliva is taken. During that visit, the women are given advice about oral health and recommended for treatment. Then, there are second, third, and fourth visits after days 15, 30, and 45, and during those visits, another sample of saliva is taken, and, again, the different indexes are registered so we can see how these indexes change as a consequence of the program. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | Clinpro White Varnish 3M ESPE®, VOCO Profluorid Varnish®, MI Varnish GC Tokio® |
| Primary outcome measure | Fluoride concentration in saliva measured with a specific fluoride electrode, before the application of the varnish, immediately after, after 15 days, 30 days, and 45 days |
| Secondary outcome measures | 1. Periodontal status, measured using the Community index of periodontal treatment needs (CPITN) over day 0, day 15, 30 and 45 2. Caries status, measured using the teeth with caries, absent because of caries or permanent teeth with fillings (CAOD) index over day 0, day 15, 30 and 45 |
| Overall study start date | 01/09/2018 |
| Completion date | 31/10/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 80 |
| Total final enrolment | 89 |
| Key inclusion criteria | 1. Pregnant woman between 16 and 31 weeks of gestation 2. No abnormal syndromes found during gynecologist exploration 3. Willing to continue with the pregnancy 4. Pregnancy not classified as high risk 5. Acceptation of the informed consent 6. Pregnant women who speak and write the Spanish language properly 7. No mental disabilities |
| Key exclusion criteria | 1. Less than 15 weeks of pregnancy 2. More than 32 weeks of pregnancy 3. Abnormal syndromes found in the fetus 4. High-risk pregnancy 5. Women who have taken the decision to abort 6. Extreme difficulties to communicate 7. Patients with permanent orthodontic treatment |
| Date of first enrolment | 01/09/2019 |
| Date of final enrolment | 01/07/2022 |
Locations
Countries of recruitment
- Spain
Study participating centre
Murcia
30008
Spain
Sponsor information
University/education
Paseo Teniente Floresta 5
Murcia
30003
Spain
| Phone | +34 868 88 3000 |
|---|---|
| 3rciclo@um.es | |
| Website | https://www.um.es |
"ROR" |
https://ror.org/03p3aeb86 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- University of Murcia
- Location
- Spain
Results and Publications
| Intention to publish date | 30/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a PhD Thesis and a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the privacy policy of the Universidad de Murcia |
Editorial Notes
15/07/2022: The recruitment end date was changed from 30/07/2022 to 01/07/2022.
17/06/2022: Trial's existence confirmed by Comité de Ética de Investigación (Research Ethics Commission) of Murcia University.
