Status:
RECRUITING
Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication
Lead Sponsor:
Copenhagen University Hospital at Herlev
Collaborating Sponsors:
Amgen
Institut Straumann AG
Conditions:
Missing Teeth
Implants
Eligibility:
All Genders
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 doc...
Eligibility Criteria
Inclusion
- 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
- \> 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
Key Trial Info
Start Date :
August 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT04741906
Start Date
August 1 2017
End Date
December 31 2025
Last Update
August 21 2024
Active Locations (1)
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1
Copenhagen University Hospital, Maxillofacial Department
Copenhagen, Danmark, Denmark, 2300