Ignite Creation Date:
2024-05-06 @ 5:37 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05375227
Status:
UNKNOWN
Last Update Posted:
2022-05-16
First Post:
2021-10-26
Brief Title:
Assessment of a Sonic Toothbrush on the Abrasion of the Gingival Tissue
Sponsor:
Philips France Commercial
Organization:
Philips France Commercial
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 HX684892 with C2 Optimal Plaque Defense head HX902210 electric toothbrush and control group assigned to the Pierre Fabre Inava 20100 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 ie primary and secondary variables of each patient by blinded examiners
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None