Assessment of a Sonic Toothbrush on the Abrasion of the Gingival Tissue (ASTA)

Philips

Status: Unknown

Conditions: Gingival Abrasion

Treatments: Other: Teeth brushing

Study type: Interventional

Funder types: Industry

Identifiers

NCT05375227

2020-A02614-35

Details and patient eligibility

About

This is a randomized, monocentric, examiner-blind, two-arm, parallel, controlled clinical research study. It aims to assess gingival abrasion by the comparison of pre- to- post-brushing after a single brushing and after 12 weeks of daily home brushing using a macro-relief scoring based on photographs of the gingiva. The study also aims to assess plaque removal, gingival inflammation, gingival recession and gingival color after 12 weeks. To enter the study, adult male and female subjects attending the service of odontology at Rothschild hospital (Paris, France) will refrain from all oral hygiene procedures for 24 hours. Subjects will have the study procedure explained to them both orally and by written instructions. Eligible patients will give their written consent to participate before being included into the study. Following a baseline clinical examination for collection of the following periodontal parameters: plaque control record (PCR), bleeding on probing (BOP), gingival recession (REC), and probing pocket depths (PD), the subjects will be randomized into two balanced groups, test group assigned to the Sonicare ProtectiveClean® HX6848/92 with C2 Optimal Plaque Defense head HX9022/10 (electric toothbrush) and control group assigned to the Pierre Fabre Inava 20/100, a reference manual toothbrush. Subjects will be instructed to brush their teeth for one minute under supervision with their assigned toothbrush and a sodium monofluorophosphate (1450 ppm F) toothpaste (elmex® SENSITIVE PROFESSIONAL) with a low level of abrasion to minimize bias due to toothpaste abrasivity. After brushing, they will again be evaluated for primary and secondary outcomes (post-brushing). Subjects will be dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects will be instructed to brush for two minutes during each tooth brushing. The subjects will report to the study site after 12 weeks of product use, at which time they will be re-evaluated for gingival abrasion, as well as for plaque removal, gingival inflammation, gingival recession and gingival color. Data (photographs and clinical measurements) will be collected, i.e. primary and secondary variables of each patient, by blinded examiners.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Dentate males and females must be at least 18 years and not more than 75 years of age
2. Patient able to understand and sign the informed consent prior to starting the study
3. Patient with a minimum of 3 teeth in each of the 4 quadrants and no/or pockets >4 mm
4. Ability and willingness to comply with all study requirements.

Exclusion criteria

1. Pregnancy
2. Patient with cervical restorations
3. Current smoker
4. Patient with orthodontic banding
5. Patient with oral lesions or periodontal diseases
6. Patient who has been deprived of his/her freedom by administrative or legal decision or who is under trusteeship/guardianship
7. Patient already using an electric toothbrush
8. Patient with conditions or circumstances, which may prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability;
9. Patient with non-plaque induced gingival diseases or localized gingival ulceration
10. Thin gingival phenotype
11. Patients with cardiac pacemakers to prevent any interference between the power toothbrush and the implantable cardiac device.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Electric Toothbrush

Experimental group

Description:

Electric toothbrush + manufacturer's instructions + professional recommendations + sodium monofluorophosphate (1450 ppm F) toothpaste (elmex® SENSITIVE PROFESSIONAL)

Treatment:

Other: Teeth brushing

Manual toothbrush

Active Comparator group

Description:

Manual toothbrush + manufacturer's instructions + professional recommendations + sodium monofluorophosphate (1450 ppm F) toothpaste (elmex® SENSITIVE PROFESSIONAL)

Treatment:

Other: Teeth brushing