Prevention of Spontaneous Dental Abscesses in Children With X-linked Hypophosphatemia : a RCT (PRADEX)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04872907 |
|
Recruitment Status :
Not yet recruiting
First Posted : May 5, 2021
Last Update Posted : May 5, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| X-linked Hypophosphatemia (XLH) | Device: adhesive system Device: fluoride varnish Drug: flowable composite | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Prevention |
| Official Title: | Prevention of Spontaneous Dental Abscesses in Children With X-linked Hypophosphatemia: a Multicentre Randomized Controlled Trial |
| Estimated Study Start Date : | June 1, 2021 |
| Estimated Primary Completion Date : | January 1, 2025 |
| Estimated Study Completion Date : | November 1, 2025 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: adhesive system + flowable composite
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
|
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). 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 |
|
Active Comparator: Fluoride varnish
Side of the mouth randomly assigned to this arm will receive the fluride varnish at baseline, M6, M12, M18 on the temporary teeth
|
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). |
- 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.
- 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 ]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 [ Time Frame: 24 month after inclusion ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 30 Months to 8 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04872907
| Contact: Violaine Smail-Faugeron, DDS, PhD | violaine.smail-faugeron@u-paris.fr |
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT04872907 |
| Other Study ID Numbers: |
APHP180575 |
| First Posted: | May 5, 2021 Key Record Dates |
| Last Update Posted: | May 5, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
X-linked hypophosphatemia, child, tooth |
|
Familial Hypophosphatemic Rickets Hypophosphatemia Phosphorus Metabolism Disorders Metabolic Diseases Rickets, Hypophosphatemic Rickets Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Hypophosphatemia, Familial Renal Tubular Transport, Inborn Errors Kidney Diseases Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Male Urogenital Diseases Metal Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Calcium Metabolism Disorders Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Fluorides Fluorides, Topical Cariostatic Agents Protective Agents |