Clinical trial NCT05375227: Assessment of a Sonic Toothbrush on the Abrasion of the Gingival Tissue
Official title: Assessment of a Sonic Toothbrush on the Abrasion of the Gingival Tissue
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Abrasion
Lead sponsor: Philips France Commercial
Sponsor class: INDUSTRY
First posted: 2022-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, monocentric, examiner-blind, two-arm, parallel, controlled clinical research study
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the gingival abrasion (GA): Macro-relief scoring
timeFrame: 90 days
Secondary outcomes:
measure: Comparison of gingival color;
timeFrame: 90 days
measure: Presence of plaque -Plaque index, PI
timeFrame: 90 days
measure: Presence of inflammation BOP
timeFrame: 90 days
measure: Presence and/or amount of gingival recession (REC)
timeFrame: 90 days
measure: Probing pocket depth (PD)
timeFrame: 90 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Rothschild Hospital
Study officials:
affiliation: Rothschild Hospital
name: Philippe BOUCHARD, Pr Dr
role: PRINCIPAL_INVESTIGATOR
References: