A Study to Evaluate the Effectiveness of Laser-Ablated Implant-Abutments to Promote Tissue Healing

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.

Inclusion Criteria:

1. At least 19 years old
2. Healthy enough to under go treatment
3. Have one or more edentulous sites that exhibit adequate natural bone and sufficient keratinized tissue
4. Demonstrated willingness to undergo study treatment and to comply with study timeline -

Exclusion Criteria:

1. Full edentulism

2. Any chronic health condition or medication that in the opinion of the investigators may adversely affect bone healing

3. Any indication of an inability to make autonomous decisions

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