Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03982615
Study type Interventional
Source University of Illinois at Chicago
Contact
Status Active, not recruiting
Phase N/A
Start date May 8, 2019
Completion date December 31, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03459547 - Soft Peri-implant Tissue Around Different Abutment Materials N/A
Completed NCT05724706 - An Evaluation of Salivary Oxidant and Antioxidant Levels in Peri-implant Health and Disease
Completed NCT05494476 - Stability of the Marginal Bone Around Subcrestal Implants N/A
Completed NCT02625597 - Assessment of the Effects of Different Implant Abutment Occluding Materials on Dental Implant Health Parameters and Microbiology N/A
Completed NCT03501199 - Comparison of Different Materials Contribution to Implants Stability N/A
Recruiting NCT05924711 - "Association of Peri-implantitis and Maxillary Sinusitis: a Case-control Study".
Not yet recruiting NCT04299386 - Effect of Nanocrystal Gels on the Management of Peri-implant Diseases N/A
Recruiting NCT03524872 - Implant/Abutment Module Stability of Original vs Compatible Connections N/A
Completed NCT03041584 - Dental Implants Placed by Using a Drill Guide Versus Non-guided Placement. Follow-up Study N/A
Recruiting NCT04906161 - Vitamin D and Serum Calcium Level Insufficiency and Early Dental Implant Failure
Active, not recruiting NCT05156294 - Effect of Soft Tissue Augmentation With an Acellular Dermal Matrix in Marginal Bone Levels Around Implants Phase 3
Active, not recruiting NCT05595772 - Comparison of Two Different Types of Platelet Concentrate to Augment Bone Around Immediate Dental Implant N/A
Recruiting NCT06135506 - Artificial Intelligence/Computer Guided Ridge Splitting for Treating Horizontal Ridge Defects N/A
Completed NCT04082143 - CATER: Comprehensive Alveolar and Tooth Esthetic Replacement Phase 3
Completed NCT06131541 - Ridge Splitting With Implant Placement Using Autogenous Tooth Graft N/A