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NCT Number: NCT04741906

Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital, Maxillofacial Department

Copenhagen, Danmark, 2300, Denmark

Location status: Recruiting

Location contact

Sanne Werner Moeller Andersen, DDS

CONTACT

[email protected]

60625950 ext. 0045

Thomas Steengaard Kofod, PhD

CONTACT

[email protected]

35450626 ext. 0045

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental implant surgery

Procedure

Dental surgery in patients treated with antiresorptive medication

Prosthetic treatment

Procedure

Prosthetic treatment and loading of the dental implants

Primary outcomes

  1. Dental implant survival

    Time frame: 3 months

    Defined as presence of the implant in the jaw after initial implant surgery before abutment surgery

  2. Dental implant survival

    Time frame: 6 months

    Defined as presence of the implant at time of final prosthetics

  3. Dental implant survival

    Time frame: 18 months

    Defined as presence of the implant 1 year after loading of the final prosthetics

  4. Dental implant survival

    Time frame: 30 months

    Defined as presence of the implant 2 years after loading of the final prosthetics

  5. 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

  6. 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

Secondary outcomes

  1. Oral Health Impact Profile

    Time frame: 30 months

    Using OHIP-14 questionnaire to evaluate oral health-related quality of life

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sanne Werner Moeller Andersen, DDS

CONTACT

[email protected]

60625950 ext. 0045

Thomas Kofod, PhD

CONTACT

[email protected]

35450626 ext. 0045

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital at Herlev

Other

Collaborators

  • Amgen
  • Institut Straumann AG

Registry information

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2021
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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