Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-03-11 @ 4:02 PM
Study NCT ID:
NCT05375227
Status:
UNKNOWN
Last Update Posted:
2022-05-16
First Post:
2021-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of a Sonic Toothbrush on the Abrasion of the Gingival Tissue
Sponsor:
Philips France Commercial
Organization:
Study Overview
Official Title:
Assessment of a Sonic Toothbrush on the Abrasion of the Gingival Tissue
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASTA
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: