X-linked HypophosphatemiaIMPLANTS-XLHNCT03879915
Dental Implants in Patients With X-linked Hypophosphatemia
An observational study of X-linked Hypophosphatemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- X-linked Hypophosphatemia
- What is being tested?
- Dental Implant placement
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 27 Sep 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with X-linked hypophosphatemia
Who may be able to join
- 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
Who cannot join
- 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:
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Odontologie - Hôpital Bretonneau - 23 rue Joseph de Maistre
Paris, 75018
Martin Biosse Duplan, DDS, PhD
About this study
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.
Read the 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)
- Conditions
- X-linked Hypophosphatemia
- Being tested
- Dental Implant placement
- Keywords
- hypophosphatemia, hypophosphatemic rickets, dental implants, osseointegration
- Medical subject headings
- Familial Hypophosphatemic Rickets, Hypophosphatemia, Rickets, Hypophosphatemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Implant placementProcedure or surgery
Surgical placement of dental implant not associated with prior or concurrent bone augmentation
| Study group | Role | What they receive |
|---|---|---|
| Prospective Dental Implant placement | Patients prospectively included and treated following current recommendations Receives: Procedure: Dental Implant placement | |
| Retrospective Dental Implant placement | Patients retrospectively included, that did not benefit from current recommendations Receives: Procedure: Dental Implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (7)
Peri-implant bone level
Peri-implant bone level measured on dental x-rays
Measured: 24 months
Clinical attachment level
Clinical attachment level, calculated from the pocket depth and gingival level measures and measured with a periodontal probe
Measured: 24 months
Lack of mobility of the implant
Lack of mobility of the implant
Measured: 6 months
Time of onset of the first implant loss
Time of onset of the first implant loss
Measured: 24 months
Cause of removal of the implant
Cause of removal of the implant
Measured: 24 months
Satisfaction of the treated patient
Satisfaction (or not) of the treated patient
Measured: 24 months
Presence of dental plaque, suppuration or bleeding at the level of the implant
Presence of dental plaque, suppuration or bleeding at the level of the implant
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start27 Sep 2019
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for X-linked HypophosphatemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Biosse Duplan, DDS, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879915
- Sponsor's protocol ID
- HAO 018045
- Acronym
- IMPLANTS-XLH
- Status last verified
- Jun 2022
- First submitted
- 15 Mar 2019
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Implants in Patients With X-linked Hypophosphatemia
- ClinicalTrials.gov ID
- NCT03879915
- Acronym / sponsor ID
- IMPLANTS-XLH / HAO 018045
- Conditions
- X-linked Hypophosphatemia
- Keywords
- hypophosphatemia, hypophosphatemic rickets, dental implants, osseointegration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Dental Implant placement | – | Procedure: Dental Implant placementPatients prospectively included and treated following current recommendations |
| Retrospective Dental Implant placement | – | Procedure: Dental Implant placementPatients retrospectively included, that did not benefit from current recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with X-linked hypophosphatemia
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
- Man or woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental Implant placementSurgical placement of dental implant not associated with prior or concurrent bone augmentation | Procedure or surgery | Prospective Dental Implant placement, Retrospective Dental Implant placement |
Primary outcome
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
7 secondary outcomes
Peri-implant bone level
Time frame: 24 months
Clinical attachment level
Time frame: 24 months
Lack of mobility of the implant
Time frame: 6 months
Time of onset of the first implant loss
Time frame: 24 months
Cause of removal of the implant
Time frame: 24 months
Satisfaction of the treated patient
Time frame: 24 months
Presence of dental plaque, suppuration or bleeding at the level of the implant
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for X-linked Hypophosphatemia
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Active, not recruitingObservational study
X-linked Hypophosphatemia Disease Monitoring Program
X-linked Hypophosphatemia, Hypophosphatemic Rickets
Recruiting
Phosphorus-31 Spectroscopy in Phosphate Diabetes
Phosphate Diabetes, X-linked Hypophosphatemia
RecruitingObservational study
Registry for Patients With X-Linked Hypophosphatemia
X-Linked Hypophosphatemia
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Biosse Duplan, DDS, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of X-linked Hypophosphatemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Biosse Duplan, DDS, PhD (+33 1 53 11 14 15, martin.biosse-duplan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant loss (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.