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

Dental Implant Failure Nos Clinical Trial

— Laser-Lok  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03982615
• Other study ID #: 2018-1358
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 8, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant Failure Nos

Intervention

Device:
• Laser-Lok abutment
Each subject will receive two dental implants. One implant will receive (by randomization) a laser-etched ("Laser-Lok") abutment.
• Standard healing abutment
Each subject will receive two dental implants. One implant will receive (by randomization) receive a standard healing abutment (not laser-etched).

Locations

Country	Name	City	State
United States	University of Illinois at Chicago, College of Dentistry, Clinical Research Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	BioHorizons, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Leong A, De Kok I, Mendonça 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. — View Citation

Outcome

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