Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dental implant surgery, Prosthetic treatment.
- Who it may be relevant to
- Registry conditions: Missing Teeth, Implants, Cancer, Osteoporosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Dental implant surgery
Dental surgery in patients treated with antiresorptive medication - Procedure Prosthetic treatment
Prosthetic treatment and loading of the dental implants
Primary outcome measures
- Dental implant survival [Time frame: 3 months]
- Dental implant survival [Time frame: 6 months]
- Dental implant survival [Time frame: 18 months]
- Dental implant survival [Time frame: 30 months]
- Dental Implant success [Time frame: 30 months]
- Absence of medical related osteonecrosis of the jaw (MRONJ) [Time frame: 30 months]
Secondary outcome measures (2)
- Oral Health Impact Profile [Time frame: 30 months]
- EORTC QLQ-H&N 35 [Time frame: 30 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Copenhagen University Hospital, Maxillofacial Department — Copenhagen
Publications
- 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 35894761
- Andersen 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 35084584
Identifiers
NCT: NCT04741906 · Oral rehabilitation of MRONJ