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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University of Alabama at Birmingham

Current Primary Outcome: Number od Participants With Consistent Connective Tissue Integration at a Histologic Level [ Time Frame: 8 weeks post-abutment placement ]

Connective tissue integration was assessed by radio graphic images of tissue and bone surrounding the implant.


Original Primary Outcome: Proliferation of Perpendicular Connective Tissue Fibers Attached to the Abutment [ Time Frame: 8 weeks post-abutment placement ]

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.


Current Secondary Outcome:

  • Grams of Force Needed to Disrupt Tissue Attachment to the Abutment [ Time Frame: 8 weeks post-abutment placement ]
    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. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.
  • Mean Change in Millimeters of Clinical Attachment to the Abutment [ Time Frame: 8 weeks post-abutment placement ]
    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. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.
  • Mean Change in Millimeters of Clinical Attachment to the Abutment [ Time Frame: 12 weeks post-abutment placement ]
    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. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.
  • Mean Change in Millimeters of Clinical Attachment to the Abutment [ Time Frame: 16 weeks post-abutment placement ]
    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. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.
  • Mean Change in Millimeters of Clinical Attachment to the Abutment [ Time Frame: 12 month post-abutment placement ]
    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. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.


Original Secondary Outcome:

  • Grams of Force Needed to Disrupt Tissue Attachment to the Abutment [ Time Frame: 8 weeks post-abutment placement ]
    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.
  • Change in millimeters of clinical attachment to the abutment [ Time Frame: 8 weeks, 12 weeks, 16 weeks, 12 months post-abutment placement ]
    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.
  • Changes in millimeters of gingival recession surrounding the abutment [ Time Frame: 8 weeks, 12 weeks, 16 weeks, 12 months post-abutment placement ]
    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.
  • Changes in Millimeters of Osseous Support to the Implant [ Time Frame: Implant placement, 16 weeks, 12 months post-implant placement ]
    Radiographs and image-processing software will be used to measure peri-implant linear bone height and to assess bone support over time.


Information By: University of Alabama at Birmingham

Dates:
Date Received: February 27, 2013
Date Started: November 2010
Date Completion:
Last Updated: November 29, 2016
Last Verified: September 2016