Clinical trial NCT04741906: Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication
Official title: Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Missing Teeth
Implants
Cancer
Osteoporosis
Keywords: Dental implants
High dose antiresorptive medication
Rehabilitation
Denosumab
Bisphosphonate
Oral rehabilitation
Adjuvant dose antiresorptive medication
Low dose antiresorptive medication
Bone modifying agents
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: Amgen
name: Institut Straumann AG
First posted: 2021-02-05
Enrollment: 225
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.

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.

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

Primary outcomes:
measure: Dental implant survival
timeFrame: 3 months
measure: Dental implant survival
timeFrame: 6 months
measure: Dental implant survival
timeFrame: 18 months
measure: Dental implant survival
timeFrame: 30 months
measure: Dental Implant success
timeFrame: 30 months
measure: Absence of medical related osteonecrosis of the jaw (MRONJ)
timeFrame: 30 months
Secondary outcomes:
measure: Oral Health Impact Profile
timeFrame: 30 months
measure: EORTC QLQ-H&N 35
timeFrame: 30 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Maxillofacial Department
state: Danmark
Study officials:
affiliation: Copenhagen University Hospital, Maxillofacial surgery
name: Sanne Werner Moeller Andersen, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.