Assessment of the remineralizing effect of a toothpaste promoting the formation of tooth minerals
| ISRCTN | ISRCTN29509071 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29509071 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 11-18 |
| Sponsor | Sechenov University |
| Funders | Russian Academic Exellence Project 5-100, Ministry of Science and Higher Education of the Russian Federation |
- Submission date
- 15/01/2020
- Registration date
- 27/01/2020
- Last edited
- 06/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Some people naturally have more sensitive teeth than others due to having thinner enamel. The enamel is the outer layer of the tooth that protects it. In many cases, the tooth’s enamel can be worn down by:
- Using a hard toothbrush
- Grinding teeth at night
- Regularly eating or drinking acidic foods and beverages
The study compares the effect of the three toothpastes on teeth hypersensitivity relief. One toothpaste contains mineral brushite, the other toothpaste contains mineral hydroxyapatite and the third toothpaste (control) container no minerals.
Who can participate?
Patients aged 20 – 25 years, with enamel hypersensitivity.
What does the study involve?
At visit one, dental plaque will be revealed with dye solution to assess oral hygiene level. Individual instructions on oral hygiene will be given. Participants will be provided with oral hygiene tools and will receive a toothpaste in a sealed container and will not know which type of toothpaste it is.
To assess the acid resistance of enamel, a small drop of acidic solution will be applied on the tooth surface for 1 minute. Then the solution will be completely rinsed off. The surface will be stained with staining solution and the intensity of color will be measured (enamel acid resistance). Staining will be repeated daily until the enamel repair (no staining). The number of days required for enamel resistance will be fixed (rate of enamel remineralisation). Participants won’t feel any discomfort during this procedure. The enamel structure will be completely restored by the end of the study.
To assess the sensitivity of enamel, air from air/water syringe will be applied perpendicular to the cervical areas of all teeth. Subjective feelings reported by the patient will be estimated according to the 4-grade scale.
Three principal visits will be with complete examination (all described tests). After each principal visit up to 5-6 daily visits for enamel remineralisation rate assessment can be required.
What are the possible benefits and risks of participating?
Tooth enamel will be restored. There are no risks.
Where is the study run from?
Institute of Dentistry, Sechenov University, Moscow, Russia
When is the study starting and how long is it expected to run for?
March 2019 to November 2019
Who is funding the study?
Supported by the "Russian Academic Exellence Project 5-100”
Who is the main contact?
Dr Marianna Arakelyan
maristom87@inbox.ru
Contact information
Scientific
Mojaiskii val, 11
Moscow
121059
Russian Federation
 ORCID ID |
0000-0001-5077-5136 |
|---|---|
| Phone | +7 (499) 240 68 20 |
| arakelyan.mg@1msmu.ru |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled double-blind study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Qualitative and quantitative assessment of remineralizing effect of prophylactic toothpaste promoting brushite formation: a randomized clinical trial |
| Study objectives | Toothpastes with brushite are equally effective to toothpastes with hydroxyapatite for enamel hypersensitivity relief. |
| Ethics approval(s) | Approved 05/12/2018, Local ethical committee of Sechenov University (Trubetskaya str, 8, Moscow, Russia, 119991; +7(495)622-97-06; iec@sechenov.ru), ref: 11-18 |
| Health condition(s) or problem(s) studied | Enamel hypersensitivity |
| Intervention | Participants were randomly assigned to one of the study groups: Group 1 - used toothpaste promoting the formation of brushite (test group) Group 2 - used toothpaste with hydroxyapatite (positive control group) Group 3 - used toothpaste without fluoride and without hydroxyapatite (negative control group) The allocation concealment was performed by the use of containers numbered by a “third party”. The toothpastes (in white bottles without any titles) were placed in the containers. The weight of the pastes and bottles in different groups was the same. The patient on enrolment received a sealed container with a toothpaste. Neither patients nor researchers were aware of the type of a toothpaste received by each patient. The patients used the prescribed pastes for a month. Control examinations were carried out at 2 weeks and 4 weeks. |
| Intervention type | Other |
| Primary outcome measure(s) |
Teeth hypersensitivity measured with Shiff index daily for 5 - 6 days |
| Key secondary outcome measure(s) |
1. Enamel acid resistance measured using the acid staining test daily for 5 - 6 days |
| Completion date | 01/11/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 54 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Age 20 - 25 years 2. Enamel hypersensitivity |
| Key exclusion criteria | 1. Orthodontic appliance 2. Malocclusion 3. Allergic reactions to the components of toothpastes 4. Systemic diseases 5. Pregnancy |
| Date of first enrolment | 10/03/2019 |
| Date of final enrolment | 10/04/2019 |
Locations
Countries of recruitment
- Russian Federation
Study participating centre
Mojaiskii val str., 11
Moscow
121059
Russian Federation
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/05/2020 | 06/09/2021 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 20/01/2020 | 05/02/2020 | No | No |
Additional files
- ISRCTN29509071_PROTOCOL_20Jan20.pdf
- uploaded 05/02/2020
Editorial Notes
06/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
05/02/2020: Uploaded protocol (not peer reviewed) as an additional file.
27/01/2020: Trial’s existence confirmed by Local ethical committee of Sechenov University
