Informations générales (source: ClinicalTrials.gov)
Dental Implants in Patients With X-linked Hypophosphatemia (IMPLANTS-XLH)
Observational
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
septembre 2019
décembre 2022
12 juillet 2025
X-linked hypophosphatemia (XLH) is a rare genetic skeletal disease where increased
phosphate wasting in the kidney leads to hypophosphatemia and prevents normal
mineralization of bone and dentin, with osteomalacia as a principal manifestation. In
previous works, the investigators have shown that adults with XLH present with more
frequent and severe periodontitis than in the general population, and that vitamin D and
phosphate supplementation improves their periodontal health, as it does for the
osteomalacia. Their medical records also reveal that early implant failure is
dramatically increased in these patients, when no supplementation is implemented, and
standard surgical protocols followed. In contrast, the investigator's preliminary data
showed that successful osseointegration was achieved with supplementation prior and after
implant placement and extended healing time. Here, the investigators propose to assess
the current recommendations for implant therapy in XLH patients, with 24 implants placed.
The current recommendations consist of: 1) supplementation with vitamin D and phosphate
for 3 months prior to implant placement and 6 months after; 2) implant healing time
extended to 6 months. If osseointegration is achieved, prosthesis will be fabricated.
Radiographic and clinical examination at 6, 12, 18 and 24 months after placement of the
definitive restoration will evaluate the implant osseointegration, crestal bone level and
peri-implant tissues health.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bretonneau | BIOSSE DUPLAN Martin | 18/04/2025 07:55:11 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Service d'Odontologie - Hôpital Bretonneau - 23 rue Joseph de Maistre - 75018 - Paris - France | Martin Biosse Duplan, DDS, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Prospective patients:
Inclusion criteria
- Man or woman
- 18 years of age or older at the time of inclusion
- Diagnosis of X-linked hypophosphatemia confirmed by an endocrinologist or a
rheumatologist
- Supplemented with phosphate and vitamin D for a period of at least 3 months
- Presenting an indication of a simple implant treatment (healed implant site with
adequate bone volume) with rehabilitation using a single or partial fixed prosthesis
- Affiliated to the national social security assurance
Exclusion Criteria:
- Opposition to participation in research
- Presence of other uncontrolled diseases that may have an impact on the periodontium
(eg diabetes or chronic kidney disease)
- Contraindications to implant treatment, such as active periodontitis and heavy
smoking (more than 10 cigarettes per day)
- Patient under guardianship or trusteeship.
Retrospective control patients:
The data will be collected retrospectively for patients who meet the following criteria:
- Man or woman
- Aged 18 years or older at the time of implant treatment
- Diagnosis of X-linked hypophosphatemia confirmed by an endocrinologist or a
rheumatologist
- Having had non-specific XLH implant treatment (absence of phosphate / vitamin D
supplementation and / or absence of prolonged healing)
- Non opposition to the use of the data of care collected as part of the research
- Absence at the time of implant treatment of uncontrolled diseases that may have had
an impact on the periodontium (diabetes, chronic kidney disease, smoking > 10
cigarettes per day)
- Not under guardianship or trusteeship.
Inclusion criteria
- Man or woman
- 18 years of age or older at the time of inclusion
- Diagnosis of X-linked hypophosphatemia confirmed by an endocrinologist or a
rheumatologist
- Supplemented with phosphate and vitamin D for a period of at least 3 months
- Presenting an indication of a simple implant treatment (healed implant site with
adequate bone volume) with rehabilitation using a single or partial fixed prosthesis
- Affiliated to the national social security assurance
Exclusion Criteria:
- Opposition to participation in research
- Presence of other uncontrolled diseases that may have an impact on the periodontium
(eg diabetes or chronic kidney disease)
- Contraindications to implant treatment, such as active periodontitis and heavy
smoking (more than 10 cigarettes per day)
- Patient under guardianship or trusteeship.
Retrospective control patients:
The data will be collected retrospectively for patients who meet the following criteria:
- Man or woman
- Aged 18 years or older at the time of implant treatment
- Diagnosis of X-linked hypophosphatemia confirmed by an endocrinologist or a
rheumatologist
- Having had non-specific XLH implant treatment (absence of phosphate / vitamin D
supplementation and / or absence of prolonged healing)
- Non opposition to the use of the data of care collected as part of the research
- Absence at the time of implant treatment of uncontrolled diseases that may have had
an impact on the periodontium (diabetes, chronic kidney disease, smoking > 10
cigarettes per day)
- Not under guardianship or trusteeship.