Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication

Conditions
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Missing Teeth, Implants, Cancer, Osteoporosis

Intervention / Treatment
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* Procedure: Dental implant surgery
* Procedure: Prosthetic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with cancer or osteoporosis, treated with antiresorptive treatment. 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: > 10 cigarettes daily 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with osteoporosis - antiresorptive treatment > 4 years. Previous tooth extraction<br>Patient with osteoporosis - antiresorptive treatment > 4 years who have had previous tooth extraction without development of MRONJ | Procedure: Dental implant surgery<br>* Dental surgery in patients treated with antiresorptive medication<br>Procedure: Prosthetic treatment<br>* Prosthetic treatment and loading of the dental implants<br>|
| Patient with osteoporosis - antiresorptive treatment > 4 years. Previous resection<br>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 | Procedure: Dental implant surgery<br>* Dental surgery in patients treated with antiresorptive medication<br>Procedure: Prosthetic treatment<br>* Prosthetic treatment and loading of the dental implants<br>|
| Patient with osteoporosis - antiresorptive treatment > 4 years. Simultaneously with resection<br>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) | Procedure: Dental implant surgery<br>* Dental surgery in patients treated with antiresorptive medication<br>Procedure: Prosthetic treatment<br>* Prosthetic treatment and loading of the dental implants<br>|
| Patient with cancer - adjuvant dose antiresorptive treatment. Previous tooth extraction<br>Patient with cancer (breast, prostate or multiple myeloma) - adjuvant dose antiresorptive treatment who have had previous tooth extraction without development of MRONJ | Procedure: Dental implant surgery<br>* Dental surgery in patients treated with antiresorptive medication<br>Procedure: Prosthetic treatment<br>* Prosthetic treatment and loading of the dental implants<br>|
| Patient with cancer - adjuvant dose antiresorptive treatment. Previous resection<br>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 | Procedure: Dental implant surgery<br>* Dental surgery in patients treated with antiresorptive medication<br>Procedure: Prosthetic treatment<br>* Prosthetic treatment and loading of the dental implants<br>|
| Patient with cancer - adjuvant dose antiresorptive treatment. Simultaneously with resection<br>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) | Procedure: Dental implant surgery<br>* Dental surgery in patients treated with antiresorptive medication<br>Procedure: Prosthetic treatment<br>* Prosthetic treatment and loading of the dental implants<br>|
| Cancer patient treated with high dose antiresorptive treatment. Previous tooth extraction<br>Cancer patient treated with high dose antiresorptive treatment who have had previous tooth extraction without development of MRONJ | Procedure: Dental implant surgery<br>* Dental surgery in patients treated with antiresorptive medication<br>Procedure: Prosthetic treatment<br>* Prosthetic treatment and loading of the dental implants<br>|
| Cancer patient treated with high dose antiresorptive treatment. Previous resection<br>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 | Procedure: Dental implant surgery<br>* Dental surgery in patients treated with antiresorptive medication<br>Procedure: Prosthetic treatment<br>* Prosthetic treatment and loading of the dental implants<br>|
| Cancer patient treated with high dose antiresorptive treatment. Simultaneously with resection<br>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) | Procedure: Dental implant surgery<br>* Dental surgery in patients treated with antiresorptive medication<br>Procedure: Prosthetic treatment<br>* Prosthetic treatment and loading of the dental implants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental implants, High dose antiresorptive medication, Rehabilitation, Denosumab, Bisphosphonate, Oral rehabilitation, Adjuvant dose antiresorptive medication, Low dose antiresorptive medication, Bone modifying agents