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

Not Applicable

Completed

• Conditions: Jaw, Edentulous, Partially
• Interventions: Device: Dental implant-abutments

• Registration Number: NCT01822223
• Lead Sponsor: University of Alabama at Birmingham

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 Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2013-02-27
• Study First Submitted QC: 2013-03-27
• Study First Posted: 2013-04-02
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Results First Submitted: 2015-10-23
• Status Verified: 2016-09
• Results First Submitted QC: 2016-11-29
• Last Update Submitted: 2016-11-29
• Results First Posted: 2017-01-25
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 -

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser-ablated dental implant-abutments	Dental implant-abutments	Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
Smooth implant-abutments	Dental implant-abutments	Smooth dental implant-abutments will be attached to surgically placed dental implants.

Primary Outcome Measures

Name	Time	Method
Number od Participants With Consistent Connective Tissue Integration at a Histologic Level	8 weeks post-abutment placement	Connective tissue integration was assessed by radio graphic images of tissue and bone surrounding the implant.

Secondary Outcome Measures

Name	Time	Method
Grams of Force Needed to Disrupt Tissue Attachment to the Abutment	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	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham School of Dentistry; 🇺🇸 Birmingham, Alabama, United States