X-linked Hypophosphatemia (XLH)Phase 3PRADEXNCT04872907
Prevention of Spontaneous Dental Abscesses in Children With X-linked Hypophosphatemia : a RCT
A Phase 3 study testing adhesive system, fluoride varnish and flowable composite in people with X-linked Hypophosphatemia (XLH), run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 months to 8 years
- Conditions the study is for
- X-linked Hypophosphatemia (XLH)
- What is being tested?
- adhesive system, fluoride varnish and flowable composite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 months to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Violaine Smail-Faugeron, DDS, PhD contact
About this study
Official title: Prevention of Spontaneous Dental Abscesses in Children With X-linked Hypophosphatemia: a Multicentre Randomized Controlled Trial
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.
Read the 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.
- Conditions
- X-linked Hypophosphatemia (XLH)
- Being tested
- adhesive system, fluoride varnish, flowable composite
- Keywords
- X-linked hypophosphatemia, child, tooth
- Medical subject headings
- Familial Hypophosphatemic Rickets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adhesive systemDevice
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).
fluoride varnishDevice
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).
flowable compositeDrug
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
| Study group | Role | What they receive |
|---|---|---|
| adhesive system + flowable composite | Experimental | 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 Receives: Device: adhesive system; Drug: flowable composite |
| Fluoride varnish | Active comparator | Side of the mouth randomly assigned to this arm will receive the fluride varnish at baseline, M6, M12, M18 on the temporary teeth Receives: Device: fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 month after inclusion
Secondary outcomes (3)
Correlation beween the occurrence of spontaneous abscesses and the age at which 1alpha-(OH)D3 was initiated
Measured: 24 month after inclusion
infectious complication
infectious complication is defined as :sepsis, cavernous sinus thrombophlebitis, mediastinitis, necrotizing fasciits, brain abscess, purulent melting of eye
Measured: 24 month after inclusion
temporary teeh extracted following a spontaneous abscess on the teeth
Measured: 24 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for X-linked Hypophosphatemia (XLH)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872907
- Sponsor's protocol ID
- APHP180575
- Acronym
- PRADEX
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Spontaneous Dental Abscesses in Children With X-linked Hypophosphatemia: a Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04872907
- Acronym / sponsor ID
- PRADEX / APHP180575
- Conditions
- X-linked Hypophosphatemia (XLH)
- Keywords
- X-linked hypophosphatemia, child, tooth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adhesive system + flowable composite | Experimental | Device: adhesive system, Drug: flowable compositeSide 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 |
| Fluoride varnish | Active comparator | Device: fluoride varnishSide of the mouth randomly assigned to this arm will receive the fluride varnish at baseline, M6, M12, M18 on the temporary teeth |
Who may qualify
- Ages
- 30 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adhesive systemadhesive 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 | adhesive system + flowable composite |
| fluoride varnishThe 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). | Device | Fluoride varnish |
| flowable compositeComposite 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 | Drug | adhesive system + flowable composite |
Primary outcome
presence of spontaneous dental abscesses
Time frame: 24 month after inclusion
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.
3 secondary outcomes
Correlation beween the occurrence of spontaneous abscesses and the age at which 1alpha-(OH)D3 was initiated
Time frame: 24 month after inclusion
infectious complication
Time frame: 24 month after inclusion
temporary teeh extracted following a spontaneous abscess on the teeth
Time frame: 24 month after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Violaine Smail-Faugeron, DDS, PhD contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing adhesive system, fluoride varnish and flowable composite in people with X-linked Hypophosphatemia (XLH), run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Violaine Smail-Faugeron, DDS, PhD (violaine.smail-faugeron@u-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of spontaneous dental abscesses (time frame: 24 month after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.