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

NCT ID: NCT01822223

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-09-30

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.

Conditions

Jaw, Edentulous, Partially

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Laser-ablated dental implant-abutments

Laser-ablated dental implant abutments will be attached to surgically placed dental implants.

Group Type: EXPERIMENTAL

Dental implant-abutments

Intervention Type: DEVICE

At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.

Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.

The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration.

Smooth implant-abutments

Smooth dental implant-abutments will be attached to surgically placed dental implants.

Group Type: ACTIVE_COMPARATOR

Dental implant-abutments

Intervention Type: DEVICE

At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.

Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.

The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration.

Interventions

Dental implant-abutments

At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.

Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.

The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration.

Intervention Type: DEVICE

Other Intervention Names

BioHorizons' Laser-Lok® abutment; BioHorizons' smooth-surfaced abutment

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

-

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioHorizons, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Michael Reddy, DMD

Professor, Dean, School of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael S Reddy, DMD, DMSc

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham School of Dentistry

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31535464 (View on PubMed)

Other Identifiers

Bio-LL-001

Identifier Type: -

Identifier Source: org_study_id