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.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 19 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham School of Dentistry | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | BioHorizons, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proliferation of Perpendicular Connective Tissue Fibers Attached to the Abutment | Tissues surrounding the abutment will be harvested via a 2 mm internal-diameter soft-tissue trephine. The tissue will be placed in an appropriately labeled vial containing a fixative; a batched histological assessment, via scanning microscopy, will be performed after tissues have been collected from 100% of participants. Microscopic analysis will categorize the proliferation and nature of peri-abutment soft tissue cells, the orientation of connective tissue fibers (if present), and will identify functionally oriented perpendicular connective tissue fibers formed as an attachment to the abutment. | 8 weeks post-abutment placement | Yes |
Secondary | Grams of Force needed to disrupt tissue attachment to the abutment | A force transducing periodontal probe instrument will electronically capture the grams of force needed to disrupt the attachment to the implant abutment; tissues will be probed from the gingival margin to the alveolar bone crest at 4 points around each abutment and an adjacent tooth: measurements will be captured from the mesial, buccal, distal, and lingual. | 8 weeks post-abutment placement | Yes |
Secondary | Change in millimeters of clinical attachment to the abutment | A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. | 8 weeks, 12 weeks, 16 weeks, 12 months post-abutment placement | Yes |
Secondary | Changes in millimeters of gingival recession surrounding the abutment | A periodontal probe will be used to measure the depth of gingival recession surrounding the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. | 8 weeks, 12 weeks, 16 weeks, 12 months post-abutment placement | Yes |
Secondary | Changes in Millimeters of Osseous Support to the Implant | Radiographs and image-processing software will be used to measure peri-implant linear bone height and to assess bone support over time. | Implant placement, 16 weeks, 12 months post-implant placement | Yes |
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