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

Not Applicable

Completed

• Conditions: Oral health; Oral Health

• Registration Number: ISRCTN12394494
• Lead Sponsor: Pierre Fabre Dermocosmetique

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30400892 (added 08/10/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-01-28
• Study Start: 2018-02-20
• Last Update Posted: 29 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 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<br> 2. Cosmetic acceptability is measured using a questionnaire filled in by the patients immediately after toothbrush use<br>