Dental Implants in Patients With X-linked Hypophosphatemia

NCT03879915 | Unknown

• 1 other identifier: HAO 018045
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

X-linked Hypophosphatemia

Keywords

hypophosphatemia; hypophosphatemic rickets; dental implants; osseointegration

Outcome Measures

Primary Outcomes (1)

• Implant loss

  Loss of the dental implant within 24 months after placement, defined by the absence of the implant in the mouth objectified during a clinical examination (spontaneous loss) or by the removal of the implant whatever the cause

  24 months

Secondary Outcomes (7)

• Peri-implant bone level

  24 months

• Clinical attachment level

  24 months

• Lack of mobility of the implant

  6 months

• Time of onset of the first implant loss

  24 months

• Cause of removal of the implant

  24 months

Study Arms (2)

Prospective Dental Implant placement

Patients prospectively included and treated following current recommendations

Procedure: Dental Implant placement

Retrospective Dental Implant placement

Patients retrospectively included, that did not benefit from current recommendations

Procedure: Dental Implant placement

Interventions

Dental Implant placement PROCEDURE

Surgical placement of dental implant not associated with prior or concurrent bone augmentation

Prospective Dental Implant placement; Retrospective Dental Implant placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with X-linked hypophosphatemia

You may qualify if:

• Man or woman
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service d'Odontologie - Hôpital Bretonneau - 23 rue Joseph de Maistre

Paris, 75018, France

RECRUITING

MeSH Terms

Conditions

Familial Hypophosphatemic Rickets; Hypophosphatemia; Rickets, Hypophosphatemic

Condition Hierarchy (Ancestors)

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; Phosphorus Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Study Officials

• Martin Biosse Duplan, DDS, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Biosse Duplan, DDS, PhD

CONTACT

+33 1 53 11 14 15; martin.biosse-duplan@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 19, 2019
• Study Start: September 27, 2019
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

FR (1)