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

Status unconfirmed · Not applicable

Conditions studied: Dental Implant Failure Nos

In brief

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.

Key facts

Study ID

NCT03982615

Run by

University of Illinois at Chicago

People needed

20

Starts

2019-05-08

Expected to finish

2021-12-31

Last updated by the study team

2021-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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