Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication
1 other identifier
observational
225
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 21, 2021
CompletedFirst Posted
Study publicly available on registry
February 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedAugust 21, 2024
August 1, 2024
8.4 years
January 21, 2021
August 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Dental implant survival
Defined as presence of the implant in the jaw after initial implant surgery before abutment surgery
3 months
Dental implant survival
Defined as presence of the implant at time of final prosthetics
6 months
Dental implant survival
Defined as presence of the implant 1 year after loading of the final prosthetics
18 months
Dental implant survival
Defined as presence of the implant 2 years after loading of the final prosthetics
30 months
Dental Implant success
Defined as less marginal bone loss than 1.5 mm the first year, and 0.2 mm per year thereafter at time of assessment
30 months
Absence of medical related osteonecrosis of the jaw (MRONJ)
Defined as no exposed bone, no fistula, no radiologic sign of MRONJ
30 months
Secondary Outcomes (2)
Oral Health Impact Profile
30 months
EORTC QLQ-H&N 35
30 months
Study Arms (9)
Patient with osteoporosis - antiresorptive treatment > 4 years. Previous tooth extraction
Patient with osteoporosis - antiresorptive treatment \> 4 years who have had previous tooth extraction without development of MRONJ
Patient with osteoporosis - antiresorptive treatment > 4 years. Previous resection
Patient with osteoporosis - antiresorptive treatment \> 4 years who have lost teeth due to having previous osteonecrosis of the jaw which has been successfully surgically treated and healed for at least 3 months without recurrence
Patient with osteoporosis - antiresorptive treatment > 4 years. Simultaneously with resection
Patient with osteoporosis - antiresorptive treatment \> 4 years with ongoing osteonecrosis of the jaw to be surgically treated with block resection of the lower jaw and insertion of a titanium reconstruction plate. Simultaneous insertion of dental implants, or resection of the upper jaw where there is sufficient remaining bone volume to have implants inserted simultaneously (without bone augmentation)
Patient with cancer - adjuvant dose antiresorptive treatment. Previous tooth extraction
Patient with cancer (breast, prostate or multiple myeloma) - adjuvant dose antiresorptive treatment who have had previous tooth extraction without development of MRONJ
Patient with cancer - adjuvant dose antiresorptive treatment. Previous resection
Patient with cancer (breast, prostate or multiple myeloma) - adjuvant dose antiresorptive treatment who have lost teeth due to having previous osteonecrosis of the jaw which has been successfully surgically treated and healed for at least 3 months without recurrence
Patient with cancer - adjuvant dose antiresorptive treatment. Simultaneously with resection
Patient with cancer (breast, prostate or multiple myeloma) - adjuvant dose antiresorptive treatment with ongoing osteonecrosis of the jaw to be surgically treated with block resection of the lower jaw and insertion of a titanium reconstruction plate. Simultaneous insertion of dental implants, or resection of the upper jaw where there is sufficient remaining bone volume to have implants inserted simultaneously (without bone augmentation)
Cancer patient treated with high dose antiresorptive treatment. Previous tooth extraction
Cancer patient treated with high dose antiresorptive treatment who have had previous tooth extraction without development of MRONJ
Cancer patient treated with high dose antiresorptive treatment. Previous resection
Cancer patient treated with high dose antiresorptive treatment who have lost teeth due to having previous osteonecrosis of the jaw which has been successfully surgically treated and healed for at least 3 months without recurrence
Cancer patient treated with high dose antiresorptive treatment. Simultaneously with resection
Cancer patients (breast, prostate or multiple myeloma) treated with high dose antiresorptive treatment with ongoing osteonecrosis of the jaw to be surgically treated with block resection of the lower jaw and insertion of a titanium reconstruction plate. Simultaneous insertion of dental implants, or resection of the upper jaw where there is sufficient remaining bone volume to have implants inserted simultaneously (without bone augmentation)
Interventions
Dental surgery in patients treated with antiresorptive medication
Prosthetic treatment and loading of the dental implants
Eligibility Criteria
Total or partial toothless patients treated with antiresorptive medication, treated at Copenhagen University Hospital due to treatment with high dose, adjuvant, or low dose \> 4 years, antiresorptive treatment. The patients had former tooth extractions or resections of the jaw at our clinic.
You may qualify if:
- 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.
You may not qualify if:
- \> 10 cigarettes daily
- HbA1c \> 53 mmol/mol
- Poor oral hygiene
- Poor general condition: ECOG score 3 or 4.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Copenhagen University Hospital at Herlevlead
- Amgencollaborator
- Institut Straumann AGcollaborator
Study Sites (1)
Copenhagen University Hospital, Maxillofacial Department
Copenhagen, Danmark, 2300, Denmark
Related Publications (2)
Ottesen C, Andersen SWM, Jensen SS, Kofod T, Gotfredsen K. Medication-related osteonecrosis of the jaw and successful implant treatment in a patient on high-dose antiresorptive medication: A case report. Clin Exp Dent Res. 2022 Oct;8(5):1059-1067. doi: 10.1002/cre2.620. Epub 2022 Jul 27.
PMID: 35894761DERIVEDAndersen SWM, Ottesen C, Gotfredsen K, Jensen SS, Kofod T, Schiodt M. Outcome of healing after dental implant placement in patients with cancer on high-dose antiresorptive medications: a prospective feasibility study. Oral Maxillofac Surg. 2023 Mar;27(1):89-100. doi: 10.1007/s10006-022-01042-5. Epub 2022 Jan 27.
PMID: 35084584DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanne Werner Moeller Andersen, DDS
Copenhagen University Hospital, Maxillofacial surgery
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Oral and Maxillofacial Surgeon
Study Record Dates
First Submitted
January 21, 2021
First Posted
February 5, 2021
Study Start
August 1, 2017
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
August 21, 2024
Record last verified: 2024-08