Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication

Cancer Clinical Trial

Official title:

Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04741906
• Other study ID #: Oral rehabilitation of MRONJ
• Status: Recruiting
• Start date: August 1, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2022
• Source: Copenhagen University Hospital at Herlev
• Contact: Sanne Werner Moeller Andersen, DDS
• Phone: 60625950
• Email: sanne[@]w-madsen.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anodontia
• Cancer
• Implants
• Missing Teeth
• Osteoporosis
• Tooth Loss

Intervention

Procedure:
• Dental implant surgery
Dental surgery in patients treated with antiresorptive medication
• Prosthetic treatment
Prosthetic treatment and loading of the dental implants

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Maxillofacial Department	Copenhagen	Danmark

Sponsors (3)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev	Amgen, Institut Straumann AG

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental implant survival	Defined as presence of the implant in the jaw after initial implant surgery before abutment surgery	3 months
Primary	Dental implant survival	Defined as presence of the implant at time of final prosthetics	6 months
Primary	Dental implant survival	Defined as presence of the implant 1 year after loading of the final prosthetics	18 months
Primary	Dental implant survival	Defined as presence of the implant 2 years after loading of the final prosthetics	30 months
Primary	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	30 months
Primary	Absence of medical related osteonecrosis of the jaw (MRONJ)	Defined as no exposed bone, no fistula, no radiologic sign of MRONJ	30 months
Secondary	Oral Health Impact Profile	Using OHIP-14 questionnaire to evaluate oral health-related quality of life	30 months
Secondary	EORTC QLQ-H&N 35	Performance of the EORTC questionnaire for the assessment of quality of life in head and neck cancer patients	30 months