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

NCT04872907 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-05-05

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Months
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2025-01-01
Completion
2025-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04872907 on ClinicalTrials.gov