Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication
NCT ID: NCT04741906
Last Updated: 2024-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
225 participants
OBSERVATIONAL
2017-08-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient with osteoporosis - antiresorptive treatment > 4 years. Previous tooth extraction
Patient with osteoporosis - antiresorptive treatment \> 4 years who have had previous tooth extraction without development of MRONJ
Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Prosthetic treatment
Prosthetic treatment and loading of the dental implants
Patient with osteoporosis - antiresorptive treatment > 4 years. Previous resection
Patient with osteoporosis - antiresorptive treatment \> 4 years who have lost teeth due to having previous osteonecrosis of the jaw which has been successfully surgically treated and healed for at least 3 months without recurrence
Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Prosthetic treatment
Prosthetic treatment and loading of the dental implants
Patient with osteoporosis - antiresorptive treatment > 4 years. Simultaneously with resection
Patient with osteoporosis - antiresorptive treatment \> 4 years with ongoing osteonecrosis of the jaw to be surgically treated with block resection of the lower jaw and insertion of a titanium reconstruction plate. Simultaneous insertion of dental implants, or resection of the upper jaw where there is sufficient remaining bone volume to have implants inserted simultaneously (without bone augmentation)
Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Prosthetic treatment
Prosthetic treatment and loading of the dental implants
Patient with cancer - adjuvant dose antiresorptive treatment. Previous tooth extraction
Patient with cancer (breast, prostate or multiple myeloma) - adjuvant dose antiresorptive treatment who have had previous tooth extraction without development of MRONJ
Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Prosthetic treatment
Prosthetic treatment and loading of the dental implants
Patient with cancer - adjuvant dose antiresorptive treatment. Previous resection
Patient with cancer (breast, prostate or multiple myeloma) - adjuvant dose antiresorptive treatment who have lost teeth due to having previous osteonecrosis of the jaw which has been successfully surgically treated and healed for at least 3 months without recurrence
Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Prosthetic treatment
Prosthetic treatment and loading of the dental implants
Patient with cancer - adjuvant dose antiresorptive treatment. Simultaneously with resection
Patient with cancer (breast, prostate or multiple myeloma) - adjuvant dose antiresorptive treatment with ongoing osteonecrosis of the jaw to be surgically treated with block resection of the lower jaw and insertion of a titanium reconstruction plate. Simultaneous insertion of dental implants, or resection of the upper jaw where there is sufficient remaining bone volume to have implants inserted simultaneously (without bone augmentation)
Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Prosthetic treatment
Prosthetic treatment and loading of the dental implants
Cancer patient treated with high dose antiresorptive treatment. Previous tooth extraction
Cancer patient treated with high dose antiresorptive treatment who have had previous tooth extraction without development of MRONJ
Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Prosthetic treatment
Prosthetic treatment and loading of the dental implants
Cancer patient treated with high dose antiresorptive treatment. Previous resection
Cancer patient treated with high dose antiresorptive treatment who have lost teeth due to having previous osteonecrosis of the jaw which has been successfully surgically treated and healed for at least 3 months without recurrence
Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Prosthetic treatment
Prosthetic treatment and loading of the dental implants
Cancer patient treated with high dose antiresorptive treatment. Simultaneously with resection
Cancer patients (breast, prostate or multiple myeloma) treated with high dose antiresorptive treatment with ongoing osteonecrosis of the jaw to be surgically treated with block resection of the lower jaw and insertion of a titanium reconstruction plate. Simultaneous insertion of dental implants, or resection of the upper jaw where there is sufficient remaining bone volume to have implants inserted simultaneously (without bone augmentation)
Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Prosthetic treatment
Prosthetic treatment and loading of the dental implants
Interventions
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Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Prosthetic treatment
Prosthetic treatment and loading of the dental implants
Eligibility Criteria
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Inclusion Criteria
* The patients should have sufficient compliance, this includes willingness to have the planned assessments
* The patient should have an expected life span at enrollment of at least 2 years.
* The local bone quality and quantity should be sufficient for implant insertion without bone augmentation and is classified according to the classification by Cawood \& Howell 1988.
Exclusion Criteria
* HbA1c \> 53 mmol/mol
* Poor oral hygiene
* Poor general condition: ECOG score 3 or 4.
* Poor prognosis: Expected survival \<2 year is an exclusion cause.
* Presence of metastases of the liver brain.
* Poor local jaw bone quality acc. to Cawood classification stage 3 or 4.
* Unwillingness to comply with the planned assessments and recordings
ALL
No
Sponsors
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Amgen
INDUSTRY
Institut Straumann AG
INDUSTRY
Copenhagen University Hospital at Herlev
OTHER
Responsible Party
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Sanne Werner Moeller Andersen
Oral and Maxillofacial Surgeon
Principal Investigators
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Sanne Werner Moeller Andersen, DDS
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital, Maxillofacial surgery
Locations
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Copenhagen University Hospital, Maxillofacial Department
Copenhagen, Danmark, Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Ottesen C, Andersen SWM, Jensen SS, Kofod T, Gotfredsen K. Medication-related osteonecrosis of the jaw and successful implant treatment in a patient on high-dose antiresorptive medication: A case report. Clin Exp Dent Res. 2022 Oct;8(5):1059-1067. doi: 10.1002/cre2.620. Epub 2022 Jul 27.
Andersen SWM, Ottesen C, Gotfredsen K, Jensen SS, Kofod T, Schiodt M. Outcome of healing after dental implant placement in patients with cancer on high-dose antiresorptive medications: a prospective feasibility study. Oral Maxillofac Surg. 2023 Mar;27(1):89-100. doi: 10.1007/s10006-022-01042-5. Epub 2022 Jan 27.
Other Identifiers
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Oral rehabilitation of MRONJ
Identifier Type: -
Identifier Source: org_study_id
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