Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication

Recruiting

• Conditions: Osteoporosis; Cancer; Missing Teeth; Implants
• Interventions: Procedure: Dental implant surgery; Procedure: Prosthetic treatment

• 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

Arm && Interventions

Group	Intervention	Description
Patient with osteoporosis - antiresorptive treatment > 4 years. Previous resection	Prosthetic treatment	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
Patient with osteoporosis - antiresorptive treatment > 4 years. Previous tooth extraction	Dental implant surgery	Patient with osteoporosis - antiresorptive treatment \> 4 years who have had previous tooth extraction without development of MRONJ
Patient with osteoporosis - antiresorptive treatment > 4 years. Previous tooth extraction	Prosthetic treatment	Patient 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	Dental implant surgery	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
Patient with cancer - adjuvant dose antiresorptive treatment. Previous resection	Prosthetic treatment	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
Patient with cancer - adjuvant dose antiresorptive treatment. Simultaneously with resection	Dental implant surgery	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)
Cancer patient treated with high dose antiresorptive treatment. Simultaneously with resection	Dental implant surgery	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)
Cancer patient treated with high dose antiresorptive treatment. Simultaneously with resection	Prosthetic treatment	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)
Patient with cancer - adjuvant dose antiresorptive treatment. Previous tooth extraction	Dental implant surgery	Patient 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. Simultaneously with resection	Prosthetic treatment	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)
Cancer patient treated with high dose antiresorptive treatment. Previous tooth extraction	Prosthetic treatment	Cancer 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	Dental implant surgery	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
Patient with osteoporosis - antiresorptive treatment > 4 years. Simultaneously with resection	Dental implant surgery	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)
Patient with cancer - adjuvant dose antiresorptive treatment. Previous tooth extraction	Prosthetic treatment	Patient with cancer (breast, prostate or multiple myeloma) - adjuvant dose antiresorptive treatment who have had previous tooth extraction without development of MRONJ
Cancer patient treated with high dose antiresorptive treatment. Previous tooth extraction	Dental implant surgery	Cancer patient treated with high dose antiresorptive treatment who have had previous tooth extraction without development of MRONJ
Patient with osteoporosis - antiresorptive treatment > 4 years. Simultaneously with resection	Prosthetic treatment	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)
Patient with cancer - adjuvant dose antiresorptive treatment. Previous resection	Dental implant surgery	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
Cancer patient treated with high dose antiresorptive treatment. Previous resection	Prosthetic treatment	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

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