Prevention of Spontaneous Dental Abscesses in Children With X-linked Hypophosphatemia : a RCT
Status:
Not yet recruiting
Trial end date:
2025-11-01
Target enrollment:
Participant gender:
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.