Status:
UNKNOWN
Guided Surgery for Horizontal Bone Augmentation
Lead Sponsor:
KU Leuven
Collaborating Sponsors:
ITI Foundation
Conditions:
Edentulous Alveolar Ridge Atrophy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the research project is to develop a novel protocol for guided bone regeneration (GBR) and assess whether such a patient specific 3D printed guide can improve the accuracy of the resulting ...
Eligibility Criteria
Inclusion
- presence of at least one site requiring bone augmentation prior to or simultaneously with implant placement;
- the above mentioned site should have adjacent teeth both mesially and distally;
- a history of edentulism in the area of implant treatment of at least 3 months;
- provision of informed consent.
Exclusion
- unlikely to be able to comply with the study procedures, as judged by the investigator;
- untreated periodontal disease;
- known or suspected current malignancy;
- history of chemotherapy within 5 years prior to study;
- history of radiation in the head and neck region;
- history of other metabolic bone diseases;
- a medical history that makes bone augmentation or implant insertion unfavorable;
- need for systemic corticosteroids;
- current or previous use of intravenous bisphosphonates;
- current or previous use of oral bisphosphonates;
- history of bone grafting and/or sinus lift in the planned implant area;
- present alcohol and/or drug abuse;
- involvement in the planning and conduct of the study;
- previous enrolment in the present study.
Key Trial Info
Start Date :
May 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05282862
Start Date
May 28 2019
End Date
March 1 2023
Last Update
March 31 2022
Active Locations (1)
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1
UZ Leuven Sint Rafaël Campus
Leuven, Belgium, 3000