Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 225
- Locations
- 1
- Primary Endpoint
- Absence of medical related osteonecrosis of the jaw (MRONJ)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts 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
- •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
- •Unwillingness to comply with the planned assessments and recordings
Outcomes
Primary Outcomes
Absence of medical related osteonecrosis of the jaw (MRONJ)
Time Frame: 30 months
Defined as no exposed bone, no fistula, no radiologic sign of MRONJ
Dental implant survival
Time Frame: 30 months
Defined as presence of the implant 2 years after loading of the final prosthetics
Dental Implant success
Time Frame: 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
Secondary Outcomes
- EORTC QLQ-H&N 35(30 months)
- Oral Health Impact Profile(30 months)
Investigators
Sanne Werner Moeller Andersen
Oral and Maxillofacial Surgeon
Copenhagen University Hospital at Herlev