Dental remineralization: effects of fluoride and calcium phosphate-based varnishes on the saliva and plaque index of children at high risk of tooth decay
| ISRCTN | ISRCTN13681286 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13681286 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | POZA |
| Sponsor | University of Murcia |
| Funder | Universidad de Murcia |
- Submission date
- 21/05/2020
- Registration date
- 26/05/2020
- Last edited
- 03/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
When dental plaque is not regularly removed, bacteria break down sugars in the diet forming acids as by-products. Lactic acid is the main acid involved in caries (tooth decay). As acids accumulate minerals are lost from the surface layer of the tooth. The imbalance in demineralization/remineralization favours the loss of calcium and phosphate from the teeth. Saliva contains the most important microelements for the remineralization and maturation of dental tissue and plays a crucial role in maintaining the oral environment. Fluoride is the agent par excellence in preventing and detaining cavities. However, remineralization may be hampered by limited levels of calcium and phosphate, and new products have been developed to ensure a constant supply. Two of the most used products are amorphous calcium phosphate stabilized with casein phosphopeptide (CPP-ACP) and tricalcium phosphate modified by fumaric acid (fTCP). The aim of this study is to study the effects of coating with CPP-ACP (MI Varnish) and fTCP (Clinpro White Varnish), applied quarterly to children at high risk of cavities, on pH, lactic acid, salivary trace elements, bacteria and plaque for 12 months.
Who can participate?
Children aged 4-12 years attending the Integrated Child Dentistry Clinic of the University of Murcia for checkups or dental treatment at a high or extreme risk of caries
What does the study involve?
Participants are randomly allocated to be treated with one of two varnishes − MI Varnish (CPP-ACP with sodium fluoride 5%) and Clinpro White Varnish (fTCP with sodium fluoride 5%) – or a placebo (dummy) varnish every 3 months for 12 months. Saliva samples are taken at the start of the study and every 3 months. The researchers assessed changes in pH, lactic acid concentrations, trace elements and bacterial concentration in saliva. They also assessed plaque and caries.
What are the possible benefits and risks of participating?
The individuals participating in the study are its main beneficiaries. The treatment is a proven technique that contributes to increasing patients’ oral health. Indeed, the findings could have important repercussions in the promotion of oral health among children, since it implies an increase in the available intervention technology.
It is important to note that this study does not pose any type of risk to any of the participating patients. On the contrary, like any dental intervention technique, this study meets all the requirements for the early and correct identification of children at risk of caries. In these interventions different oral hygiene strategies, healthy dietary habits and preventive measures were implemented, so that the caries disease was controlled and its rate of progression decreased.
Where is the study run from?
University of Murcia Dental Clinic, Hospital General Universitario Morales Meseguer, Murcia (Spain)
When is the study starting and how long is it expected to run for?
February 2016 to December 2018
Who is funding the study?
University of Murcia (Spain)
Who is the main contact?
Andrea Poza Pascual
andrea.poza@ehu.eus
Contact information
Scientific
Tiboli 1, 1º Dcha
Bilbao
48007
Spain
 ORCID ID |
0000-0001-5718-2288 |
|---|---|
| Phone | +34 (0)620025288 |
| andrea.poza@ehu.eus |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre controlled randomized clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of fluoride and calcium phosphate-based varnishes on plaque index and salivary pH, lactic acid, trace elements and bacterial count of children at high risk |
| Study acronym | - |
| Study objectives | The hypothesis was that the application of the two varnishes applied quarterly for 12 months changes either pH, lactic acid concentrations or levels of trace metals in the saliva of children at high risk of caries |
| Ethics approval(s) | Approved 19/05/2017, Ethics Research Committee and the Research Biosecurity Committee of the University of Murcia (University of Murcia: Merced Campus, Calle San Cristo 1, 30001, Murcia, Spain; +34 (0)868 88 3614; comision.etica.investigacion@um.es), ref: CIS: 1499/2017; CBE 50/2017 |
| Health condition(s) or problem(s) studied | Caries |
| Intervention | Participants were randomized to control (placebo), MI Varnish (CPP-ACP with sodium fluoride 5%) or Clinpro White Varnish (fTCP with sodium fluoride 5%) applied every 3 months. Baseline and three-monthly saliva samples were taken for 12 months. |
| Intervention type | Other |
| Primary outcome measure(s) |
Measured at baseline, 3, 6, 9 and 12 months: |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 12 Years |
| Sex | All |
| Target sample size at registration | 58 |
| Total final enrolment | 33 |
| Key inclusion criteria | Children aged 4-12 years attending the Integrated Child Dentistry Clinic of the University of Murcia for checkups or dental treatment who presented a high or extreme risk of caries according to the CAMBRA protocol |
| Key exclusion criteria | 1. Children who had received fluoride varnish or other permanent surface treatment containing fluoride in the previous 6 months 2. Children fitted with orthodontic apparatus 3. Children living in an area with fluoridated drinking water 4. Children with moderate or severe fluorosis or other morphological or anatomical abnormalities of dental development 5. Children with systemic diseases causing physical limitations 6. Children with allergy or proven/suspected sensitivity to milk proteins |
| Date of first enrolment | 01/06/2017 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- Spain
Study participating centre
Murcia
30008
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Andrea Poza Pascual (andrea.poza@ehu.eus) regarding sociodemographic data or measured outcomes (salivary pH, lactic acid, trace elements and bacterial load and plaque index). The results will be available following publication of the study and ending 5 years following article publication. Data will be shared with anyone who wishes to access it for any type of analyses. Proposals should be directed to andrea.poza@ehu.eus and to gain access, anyone requesting access to data will be required to sign a data access agreement. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/09/2021 | 03/03/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 26/05/2020 | 08/06/2020 | No | No |
Additional files
- ISRCTN13681286_PROTOCOL_26May2020.pdf
- Uploaded 08/06/2020
Editorial Notes
03/03/2022: Publication reference added.
28/08/2020: Internal review.
08/06/2020: Uploaded protocol, 26 May 2020 (not peer reviewed).
26/05/2020: Trial's existence confirmed by the Ethics Research Committee and the Research Biosecurity Committee of the University of Murcia.
