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

Primary Purpose

X-linked Hypophosphatemia (XLH)

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
adhesive system
fluoride varnish
flowable composite
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for X-linked Hypophosphatemia (XLH) focused on measuring X-linked hypophosphatemia, child, tooth

Eligibility Criteria

30 Months - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    adhesive system + flowable composite

    Fluoride varnish

    Arm Description

    Side of the mouth randomlly assigned to this arm will receive self etch adhesive system and flowable composite combination on temporary molars and self etch adhesive system on anterior temporary teeth at baseline, M6, M12, M18

    Side of the mouth randomly assigned to this arm will receive the fluride varnish at baseline, M6, M12, M18 on the temporary teeth

    Outcomes

    Primary Outcome Measures

    presence of spontaneous dental abscesses
    Spontaneous dental abscesses is defined at least one of the following criteria, in the absence of cavities or dental trauma: - Clinical criterion: Clinical vestibular, lingual or palatal gingival abscess , or Fistulized abscess, or Fistula, or Head and neck cellulitis . - Radiological criteria: Pathological bone radiolucency (periapical or interradicular), visible on a retro-alveolar image. The occurrence of at least one spontaneous abscess (binary criterion) will be evaluated for each of the treated sites (4 quadrants per child, corresponding to 2 quadrants on each side of the oral cavity). Only abscesses occurring on a tooth with a history of abscess and free from abscess at inclusion will be considered. Abscesses occurring on a tooth with a carious lesion will not be considered.

    Secondary Outcome Measures

    Correlation beween the occurrence of spontaneous abscesses and the age at which 1alpha-(OH)D3 was initiated
    infectious complication
    infectious complication is defined as :sepsis, cavernous sinus thrombophlebitis, mediastinitis, necrotizing fasciits, brain abscess, purulent melting of eye
    temporary teeh extracted following a spontaneous abscess on the teeth

    Full Information

    First Posted
    March 8, 2021
    Last Updated
    April 29, 2021
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04872907
    Brief Title
    Prevention of Spontaneous Dental Abscesses in Children With X-linked Hypophosphatemia : a RCT
    Acronym
    PRADEX
    Official Title
    Prevention of Spontaneous Dental Abscesses in Children With X-linked Hypophosphatemia: a Multicentre Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2021 (Anticipated)
    Primary Completion Date
    January 1, 2025 (Anticipated)
    Study Completion Date
    November 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 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.
    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 "spontaneous" dental abscesses not related to carious lesions or trauma. These abscesses, which occur in about 67% of children with XLH, can lead to serious complications: loss of teeth, disorders of masticatory, phonetic and aesthetic functions, disorders of occlusion and alveolar-dental development, cervicofacial cellulitis, consequences on the psychological development of the child. this study is the first randomized controlled trial for the prevention of these abscesses. Primary objective is to evaluate whether a non-invasive adhesive technique, combining the application of a self-etch adhesive system (SAM) to all faces (smooth, proximal and occlusal) of all temporary teeth (anterior and posterior) and a flowable composite applied in the grooves of the posterior temporary teeth, is effective in preventing the development of spontaneous abscesses in children with XLH, compared to the application of a fluoride varnish.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    X-linked Hypophosphatemia (XLH)
    Keywords
    X-linked hypophosphatemia, child, tooth

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    adhesive system + flowable composite
    Arm Type
    Experimental
    Arm Description
    Side of the mouth randomlly assigned to this arm will receive self etch adhesive system and flowable composite combination on temporary molars and self etch adhesive system on anterior temporary teeth at baseline, M6, M12, M18
    Arm Title
    Fluoride varnish
    Arm Type
    Active Comparator
    Arm Description
    Side of the mouth randomly assigned to this arm will receive the fluride varnish at baseline, M6, M12, M18 on the temporary teeth
    Intervention Type
    Device
    Intervention Name(s)
    adhesive system
    Intervention Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    fluoride varnish
    Intervention Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    flowable composite
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    presence of spontaneous dental abscesses
    Description
    Spontaneous dental abscesses is defined at least one of the following criteria, in the absence of cavities or dental trauma: - Clinical criterion: Clinical vestibular, lingual or palatal gingival abscess , or Fistulized abscess, or Fistula, or Head and neck cellulitis . - Radiological criteria: Pathological bone radiolucency (periapical or interradicular), visible on a retro-alveolar image. The occurrence of at least one spontaneous abscess (binary criterion) will be evaluated for each of the treated sites (4 quadrants per child, corresponding to 2 quadrants on each side of the oral cavity). Only abscesses occurring on a tooth with a history of abscess and free from abscess at inclusion will be considered. Abscesses occurring on a tooth with a carious lesion will not be considered.
    Time Frame
    24 month after inclusion
    Secondary Outcome Measure Information:
    Title
    Correlation beween the occurrence of spontaneous abscesses and the age at which 1alpha-(OH)D3 was initiated
    Time Frame
    24 month after inclusion
    Title
    infectious complication
    Description
    infectious complication is defined as :sepsis, cavernous sinus thrombophlebitis, mediastinitis, necrotizing fasciits, brain abscess, purulent melting of eye
    Time Frame
    24 month after inclusion
    Title
    temporary teeh extracted following a spontaneous abscess on the teeth
    Time Frame
    24 month after inclusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Months
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Violaine Smail-Faugeron, DDS, PhD
    Email
    violaine.smail-faugeron@u-paris.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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