Impact of Laser-modified Abutment Topography on Peri-implant Mucosal Integration (NCT03982615) | Clinical Trial Compass
UnknownNot Applicable
Impact of Laser-modified Abutment Topography on Peri-implant Mucosal Integration
United States20 participantsStarted 2019-05-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Molecular profiling of peri-implant mucosal tissues
Timeframe: 1 week, 2 week, 4 week, and 8 week after implant surgery