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Dental Implants in Patients With X-linked Hypophosphatemia (IMPLANTS-XLH)

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ClinicalTrials.gov Identifier: NCT03879915
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date March 15, 2019
First Posted Date March 19, 2019
Last Update Posted Date March 19, 2019
Estimated Study Start Date April 1, 2019
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 15, 2019)
Implant loss [ Time Frame: 24 months ]
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 15, 2019)
  • Peri-implant bone level [ Time Frame: 24 months ]
    Peri-implant bone level measured on dental x-rays
  • Clinical attachment level [ Time Frame: 24 months ]
    Clinical attachment level, calculated from the pocket depth and gingival level measures and measured with a periodontal probe
  • Lack of mobility of the implant [ Time Frame: 6 months ]
    Lack of mobility of the implant
  • Time of onset of the first implant loss [ Time Frame: 24 months ]
    Time of onset of the first implant loss
  • Cause of removal of the implant [ Time Frame: 24 months ]
    Cause of removal of the implant
  • Satisfaction of the treated patient [ Time Frame: 24 months ]
    Satisfaction (or not) of the treated patient
  • Presence of dental plaque, suppuration or bleeding at the level of the implant [ Time Frame: 24 months ]
    Presence of dental plaque, suppuration or bleeding at the level of the implant
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dental Implants in Patients With X-linked Hypophosphatemia
Official Title Dental Implants in Patients With X-linked Hypophosphatemia
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.
Detailed Description

Primary objective: to evaluate the efficacy of the specific implant management currently offered to XLH patients according to the recommendations, in terms of implant survival.

Secondary objectives: 1. to study the evolution of the peri-implant bone level within 2 years after implant placement ; 2. to study the evolution of the stability of the peri-implant tissues in the 2 years following the installation of the implant ; 3. to describe the osseointegration of the implant 6 months after insertion ; 4. to evaluate the effectiveness of the specific implant management in terms of the delay in occurrence of the first implant loss of patients ; 5. to describe the reasons for removal of the implants ; 6. to evaluate the satisfaction of the implant treated patient ; 7. to describe the occurrence of dental plaque, suppuration or bleeding around implants.

Experimental plan: this is an observational prospective study with historical control group (retrospective compendium) comparing XLH-specific implant management (prior phosphorus / vitamin D supplementation and prolonged implant healing) to non-specific management. For prospective inclusion (patients with specific implant management) patients will be recruited from adults with XLH as part of an oral assessment. After inclusion each patient will be followed 24 months. The surgical treatment and the clinical and radiographic follow-up correspond to the specific management proposed in our service to the patients presenting an XLH. Prior to implant placement, a cone-beam computed tomography scan will confirm adequate bone volume for implant placement. Implant surgery will be performed under local anesthesia following the protocols recommended by the manufacturer. The follow-up is done during the healing period and the realization of the implant prosthesis (6 months after surgery) then 12, 18 and 24 months after the surgery. It will include a clinical and radiographic examination, and will verify the presence of the implant in the mouth (survival of the implant), and the stability of the peri-implant tissues (level of attachment and bone level)

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients with X-linked hypophosphatemia
Condition X-linked Hypophosphatemia
Intervention Procedure: Dental Implant placement
Surgical placement of dental implant not associated with prior or concurrent bone augmentation
Study Groups/Cohorts
  • Prospective Dental Implant placement
    Patients prospectively included and treated following current recommendations
    Intervention: Procedure: Dental Implant placement
  • Retrospective Dental Implant placement
    Patients retrospectively included, that did not benefit from current recommendations
    Intervention: Procedure: Dental Implant placement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: March 15, 2019)
36
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2022
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Martin Biosse Duplan, MD, PhD +33 1 53 11 14 15 martin.biosse-duplan@aphp.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03879915
Other Study ID Numbers HAO 018045
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Martin Biosse Duplan, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date February 2019