Jaw, Edentulous, Partially Clinical Trial
Official title:
A Controlled, Double-Blind, Randomized, Parallel-Arm, Clinical Trial to Evaluate the Effectiveness of Laser-Ablated Implant-Abutments for Enhanced Oral Mucosal Healing
The purpose of this study is to determine which implant-abutment design is more likely to promote early soft-tissue healing processes and/or will enhance longitudinal peri-implant bone and soft-tissue health.
The study will assess the integrity of the peri-implant oral soft-tissue attachment to
implant abutments by comparing tissue responses to a laser-ablated implant-abutment and an
implant-abutment manufactured with a smooth surface.
Investigators will assess the initial post-surgical peri-implant attachment-seal and will
test whether or not the tissue-abutment interface re-forms with equal integrity when the
abutment is removed and replaced with a new abutment.
Data will include histological, radiographic, clinical, and subjective aesthetics to compare
the effectiveness of two abutment designs. Both devices are supplied by the BioHorizons
Implant Systems Inc. of Birmingham, Alabama; the abutments are analogous in design and
material except the test device has a laser-ablated surface and the control abutment is
smooth.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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