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: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Fluorides; Fluorides, Topical

Criteria

Inclusion Criteria:

• X-linked hypophosphatemia diagnosed by the doctor specializing in the disease.

• Patients with at least two healthy contralateral quadrants (right and left) at inclusion defined by the absence of symptomatic or asymptomatic spontaneous abscess, carious lesion and trauma (concussion, subluxation, dislocation, crack, fracture) on all teeth in the quadrant.

Exclusion Criteria:

• Antibiotic treatment within 15 days prior to inclusion

• Patients with a mental disability,

• Patients with cancer, heart disease, sickle cell anemia, pathological bruxism

• Patients with contraindications to study treatments