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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
| Institut Straumann AG | INDUSTRY |
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Aim of the study is to examine the feasibility of dental implant insertion in patients receiving high, adjuvant and low dose > 4 years.
The hypothesis of the present study is that dental implant therapy using submerged healing is feasible and predictable in patients receiving high, adjuvant or low dose AR for more than 4 years, as documented by clinical and radiographic signs of osseointegration after 3-4 months, sufficient implant stability for abutment connection, and implant survival rates comparable to those of healthy individuals after one year of prosthetic loading.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
| |
| 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) |
| |
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental implant surgery | Procedure | Dental surgery in patients treated with antiresorptive medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dental implant survival | Defined as presence of the implant in the jaw after initial implant surgery before abutment surgery | 3 months |
| Dental implant survival | Defined as presence of the implant at time of final prosthetics | 6 months |
| Dental implant survival | Defined as presence of the implant 1 year after loading of the final prosthetics | 18 months |
| Dental implant survival | Defined as presence of the implant 2 years after loading of the final prosthetics | 30 months |
| Dental Implant success | Defined as less marginal bone loss than 1.5 mm the first year, and 0.2 mm per year thereafter at time of assessment | 30 months |
| Absence of medical related osteonecrosis of the jaw (MRONJ) | Defined as no exposed bone, no fistula, no radiologic sign of MRONJ | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Health Impact Profile | Using OHIP-14 questionnaire to evaluate oral health-related quality of life | 30 months |
| EORTC QLQ-H&N 35 | Performance of the EORTC questionnaire for the assessment of quality of life in head and neck cancer patients |
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Inclusion Criteria:
Exclusion Criteria:
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Total or partial toothless patients treated with antiresorptive medication, treated at Copenhagen University Hospital due to treatment with high dose, adjuvant, or low dose > 4 years, antiresorptive treatment. The patients had former tooth extractions or resections of the jaw at our clinic.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanne Werner Moeller Andersen, DDS | Contact | 60625950 | 0045 | sanne@w-madsen.dk |
| Thomas Kofod, PhD | Contact | 35450626 | 0045 | thomas.steengaard@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Sanne Werner Moeller Andersen, DDS | Copenhagen University Hospital, Maxillofacial surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Maxillofacial Department | Recruiting | Copenhagen | Danmark | 2300 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35894761 | Derived | 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. | |
| 35084584 | Derived |
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| ID | Term |
|---|---|
| D000848 | Anodontia |
| D009369 | Neoplasms |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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|
| 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 |
|
| 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) |
|
| 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 |
|
| 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 |
|
| 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) |
|
| Prosthetic treatment | Procedure | Prosthetic treatment and loading of the dental implants |
|
| 30 months |
| 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. |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |