Condition category
Oral Health
Date applied
15/01/2020
Date assigned
27/01/2020
Last edited
05/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marianna Arakelyan

ORCID ID

http://orcid.org/0000-0001-5077-5136

Contact details

Mojaiskii val
11
Moscow
121059
Russian Federation
+7 (499) 240 68 20
arakelyan.mg@1msmu.ru

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

11-18

Study information

Scientific title

Qualitative and quantitative assessment of remineralizing effect of prophylactic toothpaste promoting brushite formation: a randomized clinical trial

Acronym

Study hypothesis

Toothpastes with brushite are equally effective to toothpastes with hydroxyapatite for enamel hypersensitivity relief.

Ethics approval

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

Study design

Interventional randomized controlled double-blind study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

Primary outcome measure

Teeth hypersensitivity measured with Shiff index daily for 5 - 6 days

Secondary outcome measures

1. Enamel acid resistance measured using the acid staining test daily for 5 - 6 days
2. Speed of remineralization measured as the number of days until tooth recovery using the above tests

Overall trial start date

01/03/2019

Overall trial end date

01/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 20 - 25 years
2. Enamel hypersensitivity

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

18 in each group, 54 total

Participant exclusion criteria

1. Orthodontic appliance
2. Malocclusion
3. Allergic reactions to the components of toothpastes
4. Systemic diseases
5. Pregnancy

Recruitment start date

10/03/2019

Recruitment end date

10/04/2019

Locations

Countries of recruitment

Russian Federation

Trial participating centre

Sechenov University
Institute of Dentistry Mojaiskii val str., 11
Moscow
121059
Russian Federation

Sponsor information

Organisation

Sechenov University

Sponsor details

Trubetskaya str. 8
b 2
Moscow
119991
Russian Federation
+7 4956091400
expedition@mma.ru

Sponsor type

Government

Website

http://sechenov.ru

Funders

Funder type

Government

Funder name

Russian Academic Exellence Project 5-100

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ministry of Science and Higher Education of the Russian Federation

Alternative name(s)

Федеральная целевая программа

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Russian Federation

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/08/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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