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

The Laser-Lok Trial: Impact of Laser-modified Abutment Topography on Peri-implant Mucosal Integration

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Implant Failure Nos
• Intervention / Treatment: Device: Laser-Lok abutment; Device: Standard healing abutment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago, College of Dentistry, Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: non-laser etched abutment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic parameter	mm change (> 0.1 mm) in peri-implant bone levels at mesial and distal positions	1 week and 1 year post implant surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-implant probing depth	in mm	1 week and 1 year post implant surgery
Bleeding on probing	yes/no at mesial, distal, buccal and lingual positions	1 week and 1 year post implant surgery
Gingival Index	tissue redness 1 - 4	1 week and 1 year post implant surgery

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: BioHorizons, Inc.
• Investigators: Principal Investigator: Lyndon F Cooper, DDS, PhD, University of Illinois at Chicago College of Dentistry

Publications and helpful links

General Publications

• Leong A, De Kok I, Mendonca D, Cooper LF. Molecular Assessment of Human Peri-implant Mucosal Healing at Laser-Modified and Machined Titanium Abutments. Int J Oral Maxillofac Implants. 2018 Jul/Aug;33(4):895-904. doi: 10.11607/jomi.6367.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2019
• Primary Completion (Anticipated): July 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: RNASeq; mucosal integration
• Other Study ID Numbers: 2018-1358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes