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

NCT04872907 | Unknown Phase 3

• 1 other identifier: APHP180575
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

X-linked Hypophosphatemia (XLH)

Keywords

X-linked hypophosphatemia, child, tooth

Outcome Measures

Primary Outcomes (1)

• 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.

  24 month after inclusion

Secondary Outcomes (3)

• Correlation beween the occurrence of spontaneous abscesses and the age at which 1alpha-(OH)D3 was initiated

  24 month after inclusion

• infectious complication

  24 month after inclusion

• temporary teeh extracted following a spontaneous abscess on the teeth

  24 month after inclusion

Study Arms (2)

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

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

Device: fluoride varnish

Interventions

adhesive system DEVICE

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).

adhesive system + flowable composite

fluoride varnish DEVICE

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).

Fluoride varnish

flowable composite DRUG

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

adhesive system + flowable composite

Eligibility Criteria

• Age: 30 Months - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• X-linked hypophosphatemia diagnosed by the doctor specializing in the disease.

You may not qualify if:

• Patients with a mental disability,
• Patients with cancer, heart disease, sickle cell anemia, pathological bruxism
• Patients with contraindications to study treatments

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Familial Hypophosphatemic Rickets

Interventions

flowable hybrid composite

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Hypophosphatemia; Phosphorus Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Central Study Contacts

Violaine Smail-Faugeron, DDS, PhD

CONTACT

violaine.smail-faugeron@u-paris.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: May 5, 2021
• Study Start: June 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share