Medication-related osteonecrosis of the jaw and successful implant treatment in a patient on high-dose antiresorptive medication: A case report.
Camilla Ottesen, Sanne W M Andersen, Simon S Jensen...
https://pubmed.ncbi.nlm.nih.gov/35894761Actively Recruiting
All Genders
ID04741906
Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication
Led by Copenhagen University Hospital at Herlev · Updated on 2024-08-21
225
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Copenhagen University Hospital at Herlev
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the feasibility and predictability of dental implant therapy in patients who have been treated with antiresorptive medications for more than four years due to cancer or osteoporosis. The study focuses on patients receiving high, adjuvant, or low doses of these medications and investigates clinical and radiographic signs of successful implant integration, stability for abutment connection, and survival rates comparable to healthy individuals after one year of prosthetic use. Participants receive dental implant surgery followed by prosthetic treatment to load the implants. The study groups include patients with osteoporosis or cancer treated with antiresorptive medication, some with previous tooth extraction without jaw osteonecrosis, others with previously treated osteonecrosis, and some with ongoing osteonecrosis requiring surgical jaw resection and simultaneous implant placement. The intervention involves implant insertion without bone augmentation when local bone quality and quantity are sufficient. During the study, participants undergo planned assessments including clinical and radiographic evaluations to monitor implant survival and success at multiple time points from 3 to 30 months. Additional measures include quality of life assessments using oral health and cancer-related questionnaires. The researchers monitor the absence of medication-related osteonecrosis of the jaw and implant outcomes, with participants expected to comply with all assessments and have an anticipated lifespan of at least two years.
CONDITIONS
Brief Title
Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Patient with cancer or osteoporosis treated with antiresorptive medication
- Willingness and ability to comply with planned assessments
- Expected life span of at least 2 years at enrollment
- Local jaw bone quality and quantity sufficient for implant insertion without bone augmentation according to Cawood & Howell classification
You will not qualify if you...
- Smoking more than 10 cigarettes daily
- HbA1c greater than 53 mmol/mol
- Poor oral hygiene
- Poor general condition with ECOG score 3 or 4
- Expected survival less than 2 years
- Presence of liver or brain metastases
- Poor local jaw bone quality (Cawood classification stage 3 or 4)
- Unwillingness to comply with planned assessments and recordings
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to 1 week or until wound closure
Participants undergo dental implant surgery with submerged healing, including any necessary jaw resection and insertion of titanium reconstruction plates as applicable.
1 surgery visit and daily post-operative assessments for up to 1 week
Post-operative Follow-up
Duration - 3 to 4 months
Participants are monitored for clinical and radiographic signs of implant osseointegration and implant stability to allow for abutment connection.
Weekly visits for up to 12 weeks
Prosthetic Treatment
Duration - Up to 1 month
Participants receive prosthetic treatment and loading of the dental implants.
1 baseline visit and 1 follow-up visit
Long-term Monitoring
Duration - Up to 30 months
Participants are followed to assess dental implant survival, implant success, and absence of medical related osteonecrosis of the jaw (MRONJ), as well as oral health outcomes.
Visits approximately every 6 months for up to 30 months
Trial Site Locations
Total: 1 location
1
Copenhagen University Hospital, Maxillofacial Department
Copenhagen, Danmark, Denmark, 2300
Actively Recruiting
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Research Team
S
Sanne Werner Moeller Andersen, DDS
T
Thomas Kofod, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
9
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Published Research Related To This Trial
Outcome of healing after dental implant placement in patients with cancer on high-dose antiresorptive medications: a prospective feasibility study.
Sanne Werner Møller Andersen, Camilla Ottesen, Klaus Gotfredsen...
https://pubmed.ncbi.nlm.nih.gov/35084584