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Impact of Laser-modified Abutment Topography on Peri-implant Mucosal Integration (Laser-Lok)

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ClinicalTrials.gov Identifier: NCT03982615
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
BioHorizons, Inc.
Information provided by (Responsible Party):
Lyndon F Cooper, University of Illinois at Chicago

Brief Summary:

This study is a prospective randomized split mouth study intended to evaluate the healing and health of peri-implant mucosal tissue following placement of titanium abutments with or without laser-etching.

Each subject will receive two implants. Following placement of the two 4.2mm diameter implants, one implant will receive (by randomization) a laser-etched abutment ('Laser-Lok'). The other implant will receive a standard, non-etched healing abutment. Subjects will be sequentially subdivided into four groups (n=5) and scheduled for a biopsy of the peri-implant tissues of both implants at either 8 weeks, 4 weeks, 2 weeks or 1 week after implant surgery. These biopsies, about the size of a grain of rice, will be analyzed using immunohistochemical and RNASeq techniques to identify molecular changes in response to laser etching.

At approximately 8 weeks after implant surgery, subjects will have abutments removed from both implants and digital impressions taken for final crown fabrication. At approximately 11-12 weeks after implant surgery, final crowns will be placed. Subjects return to clinic at approximately 1 year post surgery for a final study visit to assess the peri-implant mucosa surrounding both implants as measured by bleeding upon probing, probing depth and peri-apical radiography.


Condition or disease Intervention/treatment Phase
Dental Implant Failure Nos Device: Laser-Lok abutment Device: Standard healing abutment Not Applicable

Detailed Description:

A dental implant is an artificial "root" for a missing tooth made out of surgical grade metals, usually titanium, which is placed in the jaw. An implant is designed to provide a strong foundation for an artificial replacement tooth, also called a "crown". An abutment is a medical grade connector, usually made of titanium, which is placed on top of the implant, and is designed to hold and connect the crown to the implant. A crown, also called a "dental cap" is an artificial tooth, generally made of porcelain or surgical grade metals.

Osseointegration is defined as the fusion of a dental implant and abutment with the surrounding jaw bone and is a critical step during implant therapy. During this process, the titanium and bone need to become one solid structure (without any intervening inflammatory mucosal tissue in between) for optimum strength and viability.

It is hypothesized that use of an abutment whose surface has been etched with a laser ("laser-etched") will enhance the attachment of the abutment to the surrounding bone and mucosal tissue and optimize healing.

The goal of this research is to compare, by split mouth design, the healing process of peri-implant mucosal tissue adjacent to a standard healing abutment (not laser-etched) versus mucosal tissue healing adjacent to a laser-etched abutment .

Each subject will receive two implants. One implant will receive (by randomization) a standard titanium healing abutment that is not laser-etched. The other implant will receive a laser-etched ("Laser-Lok") abutment. Subjects will be sequentially subdivided into 4 groups (n=5) and scheduled for a biopsy of peri-implant tissue at both implant sites at either 8 weeks, 4 weeks, 2 weeks or 1 week after implant surgery. The biopsies, about the size of a grain of rice, will be analyzed using histological and molecular techniques to identify cellular changes in response to laser-etching.

Approximately 8 weeks after implant placement, subject will have abutments removed and digital impressions taken for final crown fabrication. At approximately 11-12 weeks post implant placement, final crowns will be placed. Subjects return to clinic at approximately 1 year post surgery for a final study visit to assess the peri-implant mucosa around both implants as measured by bleeding upon probing, probing depth and peri-apical radiography.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Prospective randomized split mouth designed study intended to evaluate the healing and health of peri-implant mucosa following placement of titanium abutments with or without laser-etching.

Each subject will receive two dental implants. One implant will receive (by randomization) a laser-etched ("Laser-Lok") abutment. The other implant will receive a standard healing abutment (not laser-etched).

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Laser-Lok Trial: Impact of Laser-modified Abutment Topography on Peri-implant Mucosal Integration
Actual Study Start Date : May 8, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Laser-Lok abutment
Laser-etched abutment
Device: Laser-Lok abutment
Each subject will receive two dental implants. One implant will receive (by randomization) a laser-etched ("Laser-Lok") abutment.
Other Name: laser-etched abutment

Active Comparator: Standard Healing abutment
Standard abutment which is not laser-etched
Device: Standard healing abutment
Each subject will receive two dental implants. One implant will receive (by randomization) receive a standard healing abutment (not laser-etched).
Other Name: non-laser etched abutment




Primary Outcome Measures :
  1. Molecular profiling of peri-implant mucosal tissues [ Time Frame: 1 week, 2 week, 4 week, and 8 week after implant surgery ]
    Fold change (> 2 fold) expression of junctional epithelial gene expression (e.g. ODAM., FDSCP)


Secondary Outcome Measures :
  1. Radiographic parameter [ Time Frame: 1 week and 1 year post implant surgery ]
    mm change (> 0.1 mm) in peri-implant bone levels at mesial and distal positions


Other Outcome Measures:
  1. Peri-implant probing depth [ Time Frame: 1 week and 1 year post implant surgery ]
    in mm

  2. Bleeding on probing [ Time Frame: 1 week and 1 year post implant surgery ]
    yes/no at mesial, distal, buccal and lingual positions

  3. Gingival Index [ Time Frame: 1 week and 1 year post implant surgery ]
    tissue redness 1 - 4



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult, able to provide informed written consent and available for 1 year follow-up visit
  • Have 2 edentulous sites requiring single tooth implants for restoration in two separate quadrants
  • Implant sites must be restorable with 4.2mm diameter implants
  • Have natural teeth adjacent (at least unilaterally) to proposed implant sites
  • Able to pay for implant crowns at UIC College of Dentistry postgraduate fees to complete treatment

Exclusion Criteria:

  • Uncontrolled/rampant caries or periodontal disease
  • Unable to demonstrate adequate home oral hygiene
  • smoker within the past 6 months
  • ASA Class 3+, immune-compromised
  • Pregnant or planning to become pregnant within 6 months
  • Severe bruxism
  • History of bisphosphonate use
  • Bone grafting required for implant placement
  • Missing tooth is too small to be restored using a 4.2mm implant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982615


Contacts
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Contact: Susan D Ferguson, MS (312) 996-7226 DentCRC@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago, College of Dentistry, Clinical Research Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Susan D Ferguson    312-996-7226    DentCRC@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
BioHorizons, Inc.
Investigators
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Principal Investigator: Lyndon F Cooper, DDS, PhD University of Illinois at Chicago College of Dentistry
Publications:
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Responsible Party: Lyndon F Cooper, Associate Dean of Research, Chair-Department of Oral Biology, College of Dentistry, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03982615    
Other Study ID Numbers: 2018-1358
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Lyndon F Cooper, University of Illinois at Chicago:
RNASeq
mucosal integration