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

NCT03982615 | Unknown FDA Device

• 1 other identifier: 2018-1358
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant Failure Nos

Keywords

RNASeq; mucosal integration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Radiographic parameter

  1 week and 1 year post implant surgery

Other Outcomes (3)

• Peri-implant probing depth

  1 week and 1 year post implant surgery

• Bleeding on probing

  1 week and 1 year post implant surgery

• Gingival Index

  1 week and 1 year post implant surgery

Study Arms (2)

Laser-Lok abutment

EXPERIMENTAL

Laser-etched abutment

Device: Laser-Lok abutment

Standard Healing abutment

ACTIVE COMPARATOR

Standard abutment which is not laser-etched

Device: Standard healing abutment

Interventions

Laser-Lok abutment DEVICE

Each subject will receive two dental implants. One implant will receive (by randomization) a laser-etched ("Laser-Lok") abutment.

Also known as: laser-etched abutment

Laser-Lok abutment

Standard healing abutment DEVICE

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

Also known as: non-laser etched abutment

Standard Healing abutment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• BioHorizons, Inc.: collaborator

Study Sites (1)

University of Illinois at Chicago, College of Dentistry, Clinical Research Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 30025007 BACKGROUND

Study Officials

• Lyndon F Cooper, DDS, PhD

  University of Illinois at Chicago College of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean of Research, Chair-Department of Oral Biology, College of Dentistry

Model Details: 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).

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: June 11, 2019
• Study Start: May 8, 2019
• Primary Completion: July 30, 2021
• Study Completion: December 31, 2021
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)