Missing TeethNCT04741906
Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication
An observational study of Missing Teeth and Implants, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
Aim of the study is to examine the feasibility of dental implant insertion in patients receiving high, adjuvant and low dose > 4 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Missing Teeth, Implants, Cancer
- What is being tested?
- Dental implant surgery and Prosthetic treatment
- Type of treatment
- Surgery or procedure
- How many people
- 225 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2017to 31 Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- > 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital, Maxillofacial Department
Copenhagen, Danmark, 2300
Sanne Werner Moeller Andersen, DDS, 60625950 ext. 0045, sanne@w-madsen.dk
Thomas Steengaard Kofod, PhD, 35450626 ext. 0045, thomas.steengaard@regionh.dk
About this study
Aim of the study is to examine the feasibility of dental implant insertion in patients receiving high, adjuvant and low dose > 4 years.
Read the 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.
- Conditions
- Missing Teeth, Implants, Cancer, Osteoporosis
- Being tested
- Dental implant surgery, Prosthetic treatment
- Keywords
- Dental implants, High dose antiresorptive medication, Rehabilitation, Denosumab, Bisphosphonate, Oral rehabilitation, Adjuvant dose antiresorptive medication, Low dose antiresorptive medication, Bone modifying agents
- Medical subject headings
- Anodontia, Neoplasms, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant surgeryProcedure or surgery
Dental surgery in patients treated with antiresorptive medication
Prosthetic treatmentProcedure or surgery
Prosthetic treatment and loading of the dental implants
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Dental implant surgery; Procedure: Prosthetic treatment | |
| 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 Receives: Procedure: Dental implant surgery; Procedure: Prosthetic treatment | |
| 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) Receives: Procedure: Dental implant surgery; Procedure: Prosthetic treatment | |
| 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 Receives: Procedure: Dental implant surgery; Procedure: Prosthetic treatment | |
| 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 Receives: Procedure: Dental implant surgery; Procedure: Prosthetic treatment | |
| 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) Receives: Procedure: Dental implant surgery; Procedure: Prosthetic treatment | |
| 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 Receives: Procedure: Dental implant surgery; Procedure: Prosthetic treatment | |
| 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 Receives: Procedure: Dental implant surgery; Procedure: Prosthetic treatment | |
| 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) Receives: Procedure: Dental implant surgery; Procedure: Prosthetic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental implant survival
Defined as presence of the implant in the jaw after initial implant surgery before abutment surgery
Measured: 3 months
Dental implant survival
Defined as presence of the implant at time of final prosthetics
Measured: 6 months
Dental implant survival
Defined as presence of the implant 1 year after loading of the final prosthetics
Measured: 18 months
Dental implant survival
Defined as presence of the implant 2 years after loading of the final prosthetics
Measured: 30 months
Dental Implant success
Defined as less marginal bone loss than 1.5 mm the first year, and 0.2 mm per year thereafter at time of assessment
Measured: 30 months
Absence of medical related osteonecrosis of the jaw (MRONJ)
Defined as no exposed bone, no fistula, no radiologic sign of MRONJ
Measured: 30 months
Secondary outcomes (2)
Oral Health Impact Profile
Using OHIP-14 questionnaire to evaluate oral health-related quality of life
Measured: 30 months
EORTC QLQ-H&N 35
Performance of the EORTC questionnaire for the assessment of quality of life in head and neck cancer patients
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Aug 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Missing TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, Institut Straumann AG
- Responsible party
- Principal investigator, Sanne Werner Moeller Andersen, Copenhagen University Hospital at Herlev
- Investigators
- Sanne Werner Moeller Andersen, DDS, Principal investigator, Copenhagen University Hospital, Maxillofacial surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741906
- Sponsor's protocol ID
- Oral rehabilitation of MRONJ
- Status last verified
- Aug 2024
- First submitted
- 21 Jan 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35894761Andersen 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.
PubMed 35084584
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication
- ClinicalTrials.gov ID
- NCT04741906
- Acronym / sponsor ID
- Oral rehabilitation of MRONJ
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Collaborators
- Amgen, Institut Straumann AG
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Patient with osteoporosis - antiresorptive treatment > 4 years. Previous tooth extraction | – | Procedure: Dental implant surgery, Procedure: Prosthetic treatmentPatient with osteoporosis - antiresorptive treatment > 4 years who have had previous tooth extraction without development of MRONJ |
| Patient with osteoporosis - antiresorptive treatment > 4 years. Previous resection | – | Procedure: Dental implant surgery, Procedure: Prosthetic treatmentPatient 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 |
| Patient with osteoporosis - antiresorptive treatment > 4 years. Simultaneously with resection | – | Procedure: Dental implant surgery, Procedure: Prosthetic treatmentPatient 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) |
| Patient with cancer - adjuvant dose antiresorptive treatment. Previous tooth extraction | – | Procedure: Dental implant surgery, Procedure: Prosthetic treatmentPatient with cancer (breast, prostate or multiple myeloma) - adjuvant dose antiresorptive treatment who have had previous tooth extraction without development of MRONJ |
| Patient with cancer - adjuvant dose antiresorptive treatment. Previous resection | – | Procedure: Dental implant surgery, Procedure: Prosthetic treatmentPatient 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 |
| Patient with cancer - adjuvant dose antiresorptive treatment. Simultaneously with resection | – | Procedure: Dental implant surgery, Procedure: Prosthetic treatmentPatient 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) |
| Cancer patient treated with high dose antiresorptive treatment. Previous tooth extraction | – | Procedure: Dental implant surgery, Procedure: Prosthetic treatmentCancer patient treated with high dose antiresorptive treatment who have had previous tooth extraction without development of MRONJ |
| Cancer patient treated with high dose antiresorptive treatment. Previous resection | – | Procedure: Dental implant surgery, Procedure: Prosthetic treatmentCancer 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 |
| Cancer patient treated with high dose antiresorptive treatment. Simultaneously with resection | – | Procedure: Dental implant surgery, Procedure: Prosthetic treatmentCancer 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- > 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental implant surgeryDental surgery in patients treated with antiresorptive medication | Procedure or surgery | Cancer patient treated with high dose antiresorptive treatment. Previous resection, Cancer patient treated with high dose antiresorptive treatment. Previous tooth extraction, Cancer patient treated with high dose antiresorptive treatment. Simultaneously with resection, Patient with cancer - adjuvant dose antiresorptive treatment. Previous resection, Patient with cancer - adjuvant dose antiresorptive treatment. Previous tooth extraction, Patient with cancer - adjuvant dose antiresorptive treatment. Simultaneously with resection, Patient with osteoporosis - antiresorptive treatment > 4 years. Previous resection, Patient with osteoporosis - antiresorptive treatment > 4 years. Previous tooth extraction, Patient with osteoporosis - antiresorptive treatment > 4 years. Simultaneously with resection |
| Prosthetic treatmentProsthetic treatment and loading of the dental implants | Procedure or surgery | Cancer patient treated with high dose antiresorptive treatment. Previous resection, Cancer patient treated with high dose antiresorptive treatment. Previous tooth extraction, Cancer patient treated with high dose antiresorptive treatment. Simultaneously with resection, Patient with cancer - adjuvant dose antiresorptive treatment. Previous resection, Patient with cancer - adjuvant dose antiresorptive treatment. Previous tooth extraction, Patient with cancer - adjuvant dose antiresorptive treatment. Simultaneously with resection, Patient with osteoporosis - antiresorptive treatment > 4 years. Previous resection, Patient with osteoporosis - antiresorptive treatment > 4 years. Previous tooth extraction, Patient with osteoporosis - antiresorptive treatment > 4 years. Simultaneously with resection |
Primary outcome
Dental implant survival
Time frame: 3 months
Defined as presence of the implant in the jaw after initial implant surgery before abutment surgery
Dental implant survival
Time frame: 6 months
Defined as presence of the implant at time of final prosthetics
Dental implant survival
Time frame: 18 months
Defined as presence of the implant 1 year after loading of the final prosthetics
Dental implant survival
Time frame: 30 months
Defined as presence of the implant 2 years after loading of the final prosthetics
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
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
2 secondary outcomes
Oral Health Impact Profile
Time frame: 30 months
EORTC QLQ-H&N 35
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Derived from this study: PubMed 35894761Ottesen 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.
- Derived from this study: PubMed 35084584Andersen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanne Werner Moeller Andersen, DDS principal investigator
Copenhagen University Hospital, Maxillofacial surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Missing Teeth and Implants, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanne Werner Moeller Andersen, DDS (60625950 ext. 0045, sanne@w-madsen.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental implant survival (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04741906, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.