Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication

Recruiting

• Conditions: Osteoporosis; Cancer; Missing Teeth; Implants

• Registration Number: NCT04741906
• Lead Sponsor: Copenhagen University Hospital at Herlev

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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absence of medical related osteonecrosis of the jaw (MRONJ)	30 months	Defined as no exposed bone, no fistula, no radiologic sign of MRONJ
Dental implant survival	30 months	Defined as presence of the implant 2 years after loading of the final prosthetics
Dental Implant success	30 months	Defined as less marginal bone loss than 1.5 mm the first year, and 0.2 mm per year thereafter at time of assessment

Secondary Outcome Measures

Name	Time	Method
EORTC QLQ-H&N 35	30 months	Performance of the EORTC questionnaire for the assessment of quality of life in head and neck cancer patients
Oral Health Impact Profile	30 months	Using OHIP-14 questionnaire to evaluate oral health-related quality of life

Trial Locations

Locations (1)

Copenhagen University Hospital, Maxillofacial Department; 🇩🇰 Copenhagen, Danmark, Denmark