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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Copenhagen University Hospital at Herlev

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut Straumann AG
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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