Status:
UNKNOWN
Prevention of Spontaneous Dental Abscesses in Children With X-linked Hypophosphatemia : a RCT
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
X-linked Hypophosphatemia (XLH)
Eligibility:
All Genders
30-8 years
Phase:
PHASE3
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 o...
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 "spo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04872907
Start Date
June 1 2021
End Date
November 1 2025
Last Update
May 5 2021
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