A new tooth brushing approach supported by an innovative hybrid toothbrush: Compared reduction of dental plaque after a single use versus an oscillating-rotating powered toothbrush

ISRCTN ISRCTN12394494
DOI https://doi.org/10.1186/ISRCTN12394494
Secondary identifying numbers 15E0508
Submission date
05/02/2018
Registration date
20/02/2018
Last edited
08/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Jean-Philippe Gatignol
Scientific

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

Study information

Study designRandomized examiner-blind single-center study parallel group.
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Other
Study typePrevention
Participant information sheet No participant information sheet available
Scientific titleOral 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
Study objectivesThe 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(s)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.
Health condition(s) or problem(s) studiedOral health
InterventionOn 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureAnti-plaque efficacy of the studied toothbrush versus a comparative toothbrush is measured using the “Silness and Loe Plaque Index” immediately after usage.
Secondary outcome measures1. 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 study start date13/08/2015
Completion date28/01/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants66 patients (33 per group)
Total final enrolment66
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment20/08/2015
Date of final enrolment27/11/2015

Locations

Countries of recruitment

  • Poland

Study participating centre

Dermscan Poland
ul. Kruczkowskiego 12
Gdansk
80-288
Poland

Sponsor information

Pierre Fabre Dermocosmetique
Industry

Pierre Fabre Medicament
Hôtel Dieu
2 Rue Viguerie
Toulouse
31025
France

ROR logo "ROR" https://ror.org/04hdhz511

Funders

Funder type

Industry

Pierre Fabre Medicament

No information available

Results and Publications

Intention to publish date15/03/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in BMC Oral Health.
IPD sharing planThe 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)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 06/11/2018 08/10/2019 Yes No

Editorial Notes

08/10/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.