Examining dental implants in patients on antiresorptive medication
Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication
This study is testing if dental implants can be safely placed in patients who have been on certain medications for bone health for a long time, and how well these implants work compared to those in healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Sex | All |
| Sponsor | Copenhagen University Hospital at Herlev Academic / other |
| Locations | 1 site (Copenhagen, Danmark) |
| Trial ID | NCT04741906 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of dental implant insertion in patients who have been treated with high, adjuvant, or low doses of antiresorptive medication for over four years. The research aims to assess clinical and radiographic signs of osseointegration after 3-4 months, as well as the stability of the implants for abutment connection and their survival rates compared to healthy individuals after one year of prosthetic loading. The study will involve dental implant surgery and subsequent prosthetic treatment to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with cancer or osteoporosis who have been on antiresorptive treatment and have sufficient local bone quality for implant insertion.
Not a fit: Patients with poor oral hygiene, significant comorbidities, or those with a poor prognosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a viable option for dental rehabilitation in patients with cancer or osteoporosis who are on antiresorptive therapy.
How similar studies have performed: Other studies have shown promising results in similar patient populations, indicating that this approach may be feasible.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen, Danmark
- Copenhagen University Hospital, Maxillofacial Department — Copenhagen, Danmark, Denmark (Recruiting)
Study contacts
- Principal investigator: Sanne Werner Moeller Andersen, DDS — Copenhagen University Hospital, Maxillofacial surgery
- Study coordinator: Sanne Werner Moeller Andersen, DDS
- Email: sanne@w-madsen.dk
- Phone: 60625950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.