Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication

August 20, 2024 updated by: Sanne Werner Moeller Andersen, Copenhagen University Hospital at Herlev
Aim of the study is to examine the feasibility of dental implant insertion in patients receiving high, adjuvant and low dose > 4 years.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sanne Werner Moeller Andersen, DDS
  • Phone Number: 0045 60625950
  • Email: sanne@w-madsen.dk

Study Contact Backup

Study Locations

  • Denmark
    • Danmark
      • Copenhagen, Danmark, Denmark, 2300
        • Recruiting
        • Copenhagen University Hospital, Maxillofacial Department
        • Contact:
          • Sanne Werner Moeller Andersen, DDS
          • Phone Number: 0045 60625950
          • Email: sanne@w-madsen.dk
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Procedure: Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Procedure: Prosthetic treatment
Prosthetic treatment and loading of the dental implants
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
Procedure: Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Procedure: Prosthetic treatment
Prosthetic treatment and loading of the dental implants
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)
Procedure: Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Procedure: Prosthetic treatment
Prosthetic treatment and loading of the dental implants
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
Procedure: Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Procedure: Prosthetic treatment
Prosthetic treatment and loading of the dental implants
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
Procedure: Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Procedure: Prosthetic treatment
Prosthetic treatment and loading of the dental implants
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)
Procedure: Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Procedure: Prosthetic treatment
Prosthetic treatment and loading of the dental implants
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
Procedure: Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Procedure: Prosthetic treatment
Prosthetic treatment and loading of the dental implants
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
Procedure: Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Procedure: Prosthetic treatment
Prosthetic treatment and loading of the dental implants
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)
Procedure: Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
Procedure: Prosthetic treatment
Prosthetic treatment and loading of the dental implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental implant survival
Time Frame: 3 months
Defined as presence of the implant in the jaw after initial implant surgery before abutment surgery
3 months
Dental implant survival
Time Frame: 6 months
Defined as presence of the implant at time of final prosthetics
6 months
Dental implant survival
Time Frame: 18 months
Defined as presence of the implant 1 year after loading of the final prosthetics
18 months
Dental implant survival
Time Frame: 30 months
Defined as presence of the implant 2 years after loading of the final prosthetics
30 months
Dental Implant success
Time Frame: 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
30 months
Absence of medical related osteonecrosis of the jaw (MRONJ)
Time Frame: 30 months
Defined as no exposed bone, no fistula, no radiologic sign of MRONJ
30 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Collaborators

Institut Straumann AG
Amgen

Investigators

  • Principal Investigator: Sanne Werner Moeller Andersen, DDS, Copenhagen University Hospital, Maxillofacial surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 21, 2021

First Submitted That Met QC Criteria

February 3, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oral rehabilitation of MRONJ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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