Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication

Copenhagen University Hospital at Herlev

Status: Enrolling

Conditions: Osteoporosis; Cancer; Implants; Missing Teeth

Treatments: Procedure: Dental implant surgery; Procedure: Prosthetic treatment

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04741906

Oral rehabilitation of MRONJ

Details and patient eligibility

About

Aim of the study is to examine the feasibility of dental implant insertion in patients receiving high, adjuvant and low dose > 4 years.

Full 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.

Enrollment: 225 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

225 participants in 9 patient groups

Patient with osteoporosis - antiresorptive treatment > 4 years. Previous tooth extraction

Description:

Patient with osteoporosis - antiresorptive treatment \> 4 years who have had previous tooth extraction without development of MRONJ

Treatment:

Procedure: Prosthetic treatment

Procedure: Dental implant surgery

Patient with osteoporosis - antiresorptive treatment > 4 years. Previous resection

Description:

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

Treatment:

Procedure: Prosthetic treatment

Procedure: Dental implant surgery

Patient with osteoporosis - antiresorptive treatment > 4 years. Simultaneously with resection

Description:

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)

Treatment:

Procedure: Prosthetic treatment

Procedure: Dental implant surgery

Patient with cancer - adjuvant dose antiresorptive treatment. Previous tooth extraction

Description:

Patient with cancer (breast, prostate or multiple myeloma) - adjuvant dose antiresorptive treatment who have had previous tooth extraction without development of MRONJ

Treatment:

Procedure: Prosthetic treatment

Procedure: Dental implant surgery

Patient with cancer - adjuvant dose antiresorptive treatment. Previous resection

Description:

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

Treatment:

Procedure: Prosthetic treatment

Procedure: Dental implant surgery

Patient with cancer - adjuvant dose antiresorptive treatment. Simultaneously with resection

Description:

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)

Treatment:

Procedure: Prosthetic treatment

Procedure: Dental implant surgery

Cancer patient treated with high dose antiresorptive treatment. Previous tooth extraction

Description:

Cancer patient treated with high dose antiresorptive treatment who have had previous tooth extraction without development of MRONJ

Treatment:

Procedure: Prosthetic treatment

Procedure: Dental implant surgery

Cancer patient treated with high dose antiresorptive treatment. Previous resection

Description:

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

Treatment:

Procedure: Prosthetic treatment

Procedure: Dental implant surgery

Cancer patient treated with high dose antiresorptive treatment. Simultaneously with resection

Description:

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)

Treatment:

Procedure: Prosthetic treatment

Procedure: Dental implant surgery