Clinical trial NCT01822223: A Study to Evaluate the Effectiveness of Laser-Ablated Implant-Abutments to Promote Tissue Healing
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Keywords: Dental Implants
Implant abutments
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: BioHorizons, Inc.
First posted: 2013-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

   -

Primary outcomes:
measure: Number od Participants With Consistent Connective Tissue Integration at a Histologic Level
timeFrame: 8 weeks post-abutment placement
Secondary outcomes:
measure: Grams of Force Needed to Disrupt Tissue Attachment to the Abutment
timeFrame: 8 weeks post-abutment placement
measure: Mean Change in Millimeters of Clinical Attachment to the Abutment
timeFrame: 8 weeks post-abutment placement
measure: Mean Change in Millimeters of Clinical Attachment to the Abutment
timeFrame: 12 weeks post-abutment placement
measure: Mean Change in Millimeters of Clinical Attachment to the Abutment
timeFrame: 16 weeks post-abutment placement
measure: Mean Change in Millimeters of Clinical Attachment to the Abutment
timeFrame: 12 month post-abutment placement
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham School of Dentistry
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael S Reddy, DMD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Geurs NC, Geisinger ML, Vassilopoulos PJ, O'Neal SJ, Haigh SJ, Reddy MS. Optimizing Connective Tissue Integration on Laser-Ablated Implant Abutments. Clin Adv Periodontics. 2016 Aug;6(3):153-159. doi: 10.1902/cap.2016.150068.