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
About this trial
This is an interventional prevention trial for X-linked Hypophosphatemia (XLH) focused on measuring X-linked hypophosphatemia, child, tooth
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
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
NCT ID
NCT04872907
First Posted
March 8, 2021
Last Updated
April 29, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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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