Prevention of Spontaneous Dental Abscesses in Children With X-linked Hypophosphatemia : a RCT

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 1, 2021

Primary Completion Date

January 1, 2025

Study Completion Date

November 1, 2025

Conditions
X-linked Hypophosphatemia (XLH)
Interventions
DEVICE

adhesive system

adhesive system G-BOND. It will be applied to healthy temporary anterior and posterior teeth The adhesive system (on side defined by randomization) will be renew at 6, 12, 18 months, on all three sides due to the physiological wear of the temporary teeth (and therefore the wear of the material).

DEVICE

fluoride varnish

The reference drug is a fluoride varnish at 22,600 ppm of the brand Duraphat 50 mg / ml, dental suspension. The varnish is applied to healthy temporary anterior and posterior teeth, on the three sides of the teeth. The reference treatment (on side defined by randomization) will be renew at 6, 12, 18 months, on all three sides due to the physiological wear of the temporary teeth (and therefore the wear of the material).

DRUG

flowable composite

"Composite Essentia HiFlo. It will be applied on healthy temporary molar grooves (on side defined by randomization).~Complete or partial renewal of the fluid composite in the grooves of the molars in the event of total or partial loss at 6, 12, 18 months"

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER