Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04872907
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-05-05
First Post:
2021-03-08
Brief Title:
Prevention of Spontaneous Dental Abscesses in Children With X-linked Hypophosphatemia a RCT
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Prevention of Spontaneous Dental Abscesses in Children With X-linked Hypophosphatemia a Multicentre Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-03
Last Known Status:
None
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:
PRADEX
Brief Summary:
This study is a prospective randomized single-blind split-mouth national multicenter trial comparing the efficacy of a self-etch adhesive system combined SAM with a flowable composite to that of a fluoride varnish for the prevention of spontaneous dental abscesses in children with XLH For each patient according to randomization one side of the oral cavity is treated with the experimental treatment application of the adhesive system to healthy anterior and posterior temporary teeth and application of the flowable composite to healthy posterior temporary teeth and the other side with the active comparator fluoride varnish The application process for both treatments is similar and will be renewed every 6 months visits at 6 12 18 and 24 months systematically for the SAM and the varnish and in case of partial or total loss of the composite
Detailed Description:
X-linked hypophosphatemia XLH is a vitamin D-resistant familial rickets resulting from a mutation of the PHEX gene One of the major clinical disorders is dental pulp necrosis which results in spontaneous dental abscesses not related to carious lesions or trauma These abscesses which occur in about 67 of children with XLH can lead to serious complications loss of teeth disorders of masticatory phonetic and aesthetic functions disorders of occlusion and alveolar-dental development cervicofacial cellulitis consequences on the psychological development of the child this study is the first randomized controlled trial for the prevention of these abscesses
Primary objective is to evaluate whether a non-invasive adhesive technique combining the application of a self-etch adhesive system SAM to all faces smooth proximal and occlusal of all temporary teeth anterior and posterior and a flowable composite applied in the grooves of the posterior temporary teeth is effective in preventing the development of spontaneous abscesses in children with XLH compared to the application of a fluoride varnish
Primary objective is to evaluate whether a non-invasive adhesive technique combining the application of a self-etch adhesive system SAM to all faces smooth proximal and occlusal of all temporary teeth anterior and posterior and a flowable composite applied in the grooves of the posterior temporary teeth is effective in preventing the development of spontaneous abscesses in children with XLH compared to the application of a fluoride varnish
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