Condition category
Oral Health
Date applied
05/02/2018
Date assigned
20/02/2018
Last edited
12/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Oral health is one of the major concerns of dental health care professionals. In Western industrialized countries, the toothbrush is widely accepted as a simple, affordable and effective device to mechanically remove dental plaque in a shorter time. However, a wide diversity in brushing methods does exist depending on the position and motion of the brush. The aim of this study was to evaluate and compare the clinical efficacy of the first hybrid toothbrush (INAVA Hybrid) using combined mode (manual gesture associated to sonic vibrations) to a marketed oscillating-rotating powered toothbrush (Oral-B Vitality) in the reduction of dental plaque after a single use.

Who can participate?
Adult subjects presenting a deposit of dental plaque covering up to 1/3 of the cervical and a mild inflammation of gingival marginal or papillary.

What does the study involve?
On the day of the study, the subjects come to the laboratory after refraining from all oral hygiene procedures for 24 hours and without eating, drinking and smoking for the last four hours before the visit. The dentist performs a clinical examination of the state of the oral cavity, with a ”Silness and Löe Plaque Index” (PI) score and “Modified Gingival Index“ (MGI) score. After randomization, each participant receives instructions on how to use the assigned toothbrush device. The same toothpaste is provided to all the subjects. A single brushing with the studied product (hybrid toothbrush) or the comparative product (oscillating-rotating device) is performed for exactly two minutes under supervision to ensure compliance with the manufacturer’s usage instructions. Immediately after brushing, another clinical examination of the state of the oral cavity is performed by the dentist and another PI scoring is done. The participants complete a self-assessment questionnaire of the products’ acceptability after the first use.

What are the possible benefits and risks of participating?
There are no known benefits with participating in this study. The possible risk is bleeding of the gingiva.

Where is the study run from?
Demscan Poland (Gdansk- Poland)

When is the study starting and how long is it expected to run for?
September 2015 to November 2015

Who is funding the study?
Pierre Fabre Oral Care (France)

Who is the main contact?
Dr JP Gatignol (Public)
jean.philippe.gatignol@pierre-fabre.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jean-Philippe Gatignol

ORCID ID

Contact details

Institut de Recherche Pierre Fabre
17 Avenue Jean Moulin
Castres
81106
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15E0508

Study information

Scientific title

Oral and dental efficacy and tolerance of an electric toothbrush versus a comparative electric toothbrush marketed - use test under dental control of the reduction of dental plaque after a single use

Acronym

Study hypothesis

The new hybrid toothbrush combining manual gesture associated to sonic vibrations is as efficient as a marketed oscillating-rotating powered toothbrush in the reduction of dental plaque.

Ethics approval

Ethics approval not required: the study takes place in Poland. In that country, an electric toothbrush is considered to be a domestic electric apparatus. Conducting a clinical study with such devices does not require any approval by an ethics committee. However, the study is conducted in compliance with Good Clinical Practices and in accordance with the “Declaration of Helsinki.” Written informed consents for participation in the clinical study is obtained for all participants.

Study design

Randomized examiner-blind single-center study parallel group.

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

Oral health

Intervention

On the day of the study, participants come to the laboratory after refraining from all oral hygiene procedures for 24 hours and without eating, drinking and smoking for the last four hours before the visit. The dentist performs a clinical examination of the state of the oral cavity. Participants with a ”Silness and Löe Plaque Index” (PI) score between 1.0 and 2.0 and “Modified Gingival Index“ (MGI) score between 1.0 and 2.0 are included in the study. A randomisation list for toothbrush allocation is generated using the sub routine PROC PLAN of the statistical software SAS 9.4. After randomisation, each participant receives instructions on how to use the assigned toothbrush device. The same toothpaste (Elgydium, Pierre Fabre Oral Care, France) is provided to all the subjects. A single brushing with the studied toothbrush (INAVA Hybrid - Pierre Fabre Oral Care, France) or the comparative toothbrush (Oral-B Vitality 2D Sensitive Clean - Procter & Gamble, USA) are performed for exactly two minutes under supervision to ensure compliance with the manufacturer’s usage instructions. Immediately after brushing, another clinical examination of the state of the oral cavity is performed by the dentist and another PI scoring is done. Possible adverse reactions are noted. For this post-brushing evaluation, the dentist is blinded as to the device used. The participants complete a self-assessment questionnaire of the products’ acceptability after the first use.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Anti-plaque efficacy of the studied toothbrush versus a comparative toothbrush is measured using the “Silness and Loe Plaque Index” immediately after usage.

Secondary outcome measures

1. Tolerance of study products is measured using clinical examinations of the oral cavity (teeth, gums, mucous membranes) for physical and functionals signs before and immediately after toothbrush use
2. Cosmetic acceptability is measured using a questionnaire filled in by the patients immediately after toothbrush use

Overall trial start date

13/08/2015

Overall trial end date

28/01/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients aged between 18 to 70 years old
2. Presenting at least 20 natural teeth, without implants, prosthesis or dental braces on the studied teeth
3. Presenting a “Silness and Löe Plaque Index” between 1.0 and 2.0 and a “Modified Gingival Index” between 1.0 and 2.0. at the time of inclusion
4. Not using preventive dental medications, antibiotics and/or steroids during one week before the beginning of the study
5. Never used an electric toothbrush

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

66 patients (33 per group)

Participant exclusion criteria

1. Pregnant or nursing women or not willing to take precautions during the study
2. Subject having an uncompromised manual dexterity
3. Subject having a disease liable to interfere with study data according to the investigator
4. Subject having a cutaneous-mucosal disease liable to interfere with study data according to the investigator, especially: herpes or medical history herpes, aphtosis and medical history of aphtosis, lichen planus, chronic lupus erythematosus
5. Subject having undergone surgery, chemical or physical treatment to the concerned area in the last 3 months
6. Subject having a background of intolerance or allergy to cosmetics, to drugs or to other substances (fruits, lactose intolerant, nuts, etc.) that makes the subject ineligible or places him/her at undue risk or that forbids him/her not to eat and drink 4 hours before the study
7. Subject planning to have any dental care during the study
8. Subject having applied any topical or local product (dental gel, mouthwash, etc.) the day of the inclusion visit on the study area

Recruitment start date

20/08/2015

Recruitment end date

27/11/2015

Locations

Countries of recruitment

Poland

Trial participating centre

Dermscan Poland
ul. Kruczkowskiego 12
Gdansk
80-288
Poland

Sponsor information

Organisation

Pierre Fabre Dermocosmetique

Sponsor details

Pierre Fabre Medicament
Hôtel Dieu
2 Rue Viguerie
Toulouse
31025
France

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Pierre Fabre Medicament

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in BMC Oral Health.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr JP Gatignol (jean.philippe.gatignol@pierre-fabre.com)

Intention to publish date

15/03/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes