Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCopenhagen University Hospital at Herlev
About this trial
Aim of the study is to examine the feasibility of dental implant insertion in patients receiving high, adjuvant and low dose \> 4 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
> 10 cigarettes daily
HbA1c > 53 mmol/mol
Poor oral hygiene
Poor general condition: ECOG score 3 or 4.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Dental implant surgery
Procedure/SurgeryDental surgery in patients treated with antiresorptive medication
Prosthetic treatment
Procedure/SurgeryProsthetic treatment and loading of the dental implants
Treatment groups
225 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: Patient with osteoporosis - antiresorptive treatment > 4 years. Previous tooth extraction2 interventions
Group B: Patient with osteoporosis - antiresorptive treatment > 4 years. Previous resection2 interventions
Group C: Patient with osteoporosis - antiresorptive treatment > 4 years. Simultaneously with resection2 interventions
Group D: Patient with cancer - adjuvant dose antiresorptive treatment. Previous tooth extraction2 interventions
Group E: Patient with cancer - adjuvant dose antiresorptive treatment. Previous resection2 interventions
Group F: Patient with cancer - adjuvant dose antiresorptive treatment. Simultaneously with resection2 interventions
Group G: Cancer patient treated with high dose antiresorptive treatment. Previous tooth extraction2 interventions
Group H: Cancer patient treated with high dose antiresorptive treatment. Previous resection2 interventions
Group I: Cancer patient treated with high dose antiresorptive treatment. Simultaneously with resection2 interventions
Trial outcomes
Primary outcomes
1
Dental implant survival
Defined as presence of the implant in the jaw after initial implant surgery before abutment surgery
Time frame
3 months2
Dental implant survival
Defined as presence of the implant at time of final prosthetics
Time frame
6 months3
Dental implant survival
Defined as presence of the implant 1 year after loading of the final prosthetics
Time frame
18 months4
Dental implant survival
Defined as presence of the implant 2 years after loading of the final prosthetics
Time frame
30 monthsSecondary outcomes
1
Oral Health Impact Profile
Using OHIP-14 questionnaire to evaluate oral health-related quality of life
Time frame
30 months2
EORTC QLQ-H&N 35
Performance of the EORTC questionnaire for the assessment of quality of life in head and neck cancer patients
Time frame
30 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Copenhagen University Hospital at Herlev
Lead sponsor
Amgen
Collaborator
Institut Straumann AG
Collaborator
Source ClinicalTrials.gov