NCT01822223

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

January 25, 2017

Completed
Last Updated

January 25, 2017

Status Verified

September 1, 2016

Enrollment Period

3.8 years

First QC Date

February 27, 2013

Results QC Date

October 23, 2015

Last Update Submit

November 29, 2016

Conditions

Jaw, Edentulous, Partially

Keywords

Dental ImplantsImplant abutments

Outcome Measures

Primary Outcomes (1)

  • Number od Participants With Consistent Connective Tissue Integration at a Histologic Level

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

    8 weeks post-abutment placement

Secondary Outcomes (5)

  • Grams of Force Needed to Disrupt Tissue Attachment to the Abutment

    8 weeks post-abutment placement

  • Mean Change in Millimeters of Clinical Attachment to the Abutment

    8 weeks post-abutment placement

  • Mean Change in Millimeters of Clinical Attachment to the Abutment

    12 weeks post-abutment placement

  • Mean Change in Millimeters of Clinical Attachment to the Abutment

    16 weeks post-abutment placement

  • Mean Change in Millimeters of Clinical Attachment to the Abutment

    12 month post-abutment placement

Study Arms (2)

Laser-ablated dental implant-abutments

EXPERIMENTAL

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

Device: Dental implant-abutments

Smooth implant-abutments

ACTIVE COMPARATOR

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

Device: Dental implant-abutments

Interventions

Dental implant-abutmentsDEVICE

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.

Also known as: BioHorizons' Laser-Lok® abutment, BioHorizons' smooth-surfaced abutment
Laser-ablated dental implant-abutmentsSmooth implant-abutments

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 19 years old
  • Healthy enough to under go treatment
  • Have one or more edentulous sites that exhibit adequate natural bone and sufficient keratinized tissue
  • Demonstrated willingness to undergo study treatment and to comply with study timeline -

You may not qualify if:

  • Full edentulism
  • Any chronic health condition or medication that in the opinion of the investigators may adversely affect bone healing
  • Any indication of an inability to make autonomous decisions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham School of Dentistry

Birmingham, Alabama, 35294-0007, United States

Location

Related Publications (1)

  • 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.

    PMID: 31535464BACKGROUND

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Results Point of Contact

Title
Michael S. Reddy, DMD, DMSc
Organization
University of Alabama at Birmingham
mreddy@uab.edu
2059344720

Study Officials

  • Michael S Reddy, DMD, DMSc

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Dean, School of Dentistry

Study Record Dates

First Submitted

February 27, 2013

First Posted

April 2, 2013

Study Start

November 1, 2010

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

January 25, 2017

Results First Posted

January 25, 2017

Record last verified: 2016-09

Locations

US(1)