Cancer, Implants, Missing Teeth, Osteoporosis
Conditions
Keywords
Dental implants, High dose antiresorptive medication, Rehabilitation, Denosumab, Bisphosphonate, Oral rehabilitation, Adjuvant dose antiresorptive medication, Low dose antiresorptive medication, Bone modifying agents
Brief summary
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
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.
Interventions
PROCEDUREDental implant surgery
Dental surgery in patients treated with antiresorptive medication
PROCEDUREProsthetic treatment
Prosthetic treatment and loading of the dental implants
Sponsors
Amgen
Institut Straumann AG
Copenhagen University Hospital at Herlev
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dental implant survival | 3 months | Defined as presence of the implant in the jaw after initial implant surgery before abutment surgery |
| Dental Implant success | 30 months | Defined as less marginal bone loss than 1.5 mm the first year, and 0.2 mm per year thereafter at time of assessment |
| Absence of medical related osteonecrosis of the jaw (MRONJ) | 30 months | Defined as no exposed bone, no fistula, no radiologic sign of MRONJ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral Health Impact Profile | 30 months | Using OHIP-14 questionnaire to evaluate oral health-related quality of life |
| EORTC QLQ-H&N 35 | 30 months | Performance of the EORTC questionnaire for the assessment of quality of life in head and neck cancer patients |
Countries
Denmark
Contacts
Primary ContactSanne Werner Moeller Andersen, DDS
Backup ContactThomas Kofod, PhD
Outcome results
None listed