Dental Implant Failure NosLaser-LokNCT03982615
Impact of Laser-modified Abutment Topography on Peri-implant Mucosal Integration
A study testing Laser-Lok abutment and Standard healing abutment in people with Dental Implant Failure Nos, run by University of Illinois Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failure Nos
- What is being tested?
- Laser-Lok abutment and Standard healing abutment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- History of bisphosphonate use
- Bone grafting required for implant placement
- Missing tooth is too small to be restored using a 4.2mm implant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago, College of Dentistry, Clinical Research Center
Chicago, Illinois, 60612
About this study
Official title: The Laser-Lok Trial: Impact of Laser-modified Abutment Topography on Peri-implant Mucosal Integration
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.
Read the detailed 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.
- Conditions
- Dental Implant Failure Nos
- Being tested
- Laser-Lok abutment, Standard healing abutment
- Keywords
- RNASeq, mucosal integration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser-Lok abutmentDevice
Also called laser-etched abutment
Each subject will receive two dental implants. One implant will receive (by randomization) a laser-etched ("Laser-Lok") abutment.
Standard healing abutmentDevice
Also called non-laser etched abutment
Each subject will receive two dental implants. One implant will receive (by randomization) receive a standard healing abutment (not laser-etched).
| Study group | Role | What they receive |
|---|---|---|
| Laser-Lok abutment | Experimental | Laser-etched abutment Receives: Device: Laser-Lok abutment |
| Standard Healing abutment | Active comparator | Standard abutment which is not laser-etched Receives: Device: Standard healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular profiling of peri-implant mucosal tissues
Fold change (> 2 fold) expression of junctional epithelial gene expression (e.g. ODAM., FDSCP)
Measured: 1 week, 2 week, 4 week, and 8 week after implant surgery
Secondary outcomes (1)
Radiographic parameter
mm change (> 0.1 mm) in peri-implant bone levels at mesial and distal positions
Measured: 1 week and 1 year post implant surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start8 May 2019
- Primary completion30 Jul 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Implant Failure NosStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- BioHorizons, Inc.
- Responsible party
- Principal investigator, Lyndon F Cooper, University of Illinois Chicago
- Investigators
- Lyndon F Cooper, DDS, PhD, Principal investigator, University of Illinois at Chicago College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982615
- Sponsor's protocol ID
- 2018-1358
- Acronym
- Laser-Lok
- Status last verified
- Mar 2021
- First submitted
- 21 May 2019
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30025007
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Laser-Lok Trial: Impact of Laser-modified Abutment Topography on Peri-implant Mucosal Integration
- ClinicalTrials.gov ID
- NCT03982615
- Acronym / sponsor ID
- Laser-Lok / 2018-1358
- Conditions
- Dental Implant Failure Nos
- Keywords
- RNASeq, mucosal integration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- BioHorizons, Inc.
- Study start
- 8 May 2019 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Laser-Lok abutment | Experimental | Device: Laser-Lok abutmentLaser-etched abutment |
| Standard Healing abutment | Active comparator | Device: Standard healing abutmentStandard abutment which is not laser-etched |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser-Lok abutmentAlso: laser-etched abutmentEach subject will receive two dental implants. One implant will receive (by randomization) a laser-etched ("Laser-Lok") abutment. | Device | Laser-Lok abutment |
| Standard healing abutmentAlso: non-laser etched abutmentEach subject will receive two dental implants. One implant will receive (by randomization) receive a standard healing abutment (not laser-etched). | Device | Standard Healing abutment |
Primary outcome
Molecular profiling of peri-implant mucosal tissues
Time frame: 1 week, 2 week, 4 week, and 8 week after implant surgery
Fold change (> 2 fold) expression of junctional epithelial gene expression (e.g. ODAM., FDSCP)
1 secondary outcome
Radiographic parameter
Time frame: 1 week and 1 year post implant surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Background: PubMed 30025007Leong 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.
- Individual participant dataSharing planned: No
Related trials for Dental Implant Failure Nos
Recruiting
Guided Lateral Sinus Lifting Using Autologous Serum Albumin/Platelet-Rich Fibrin
Sinus Perforation, Dental Implant Failure Nos
Recruiting
Clinical Efficacy of Nobel Parallel CC Implants With on1 Abutment in Posterior Area Participants
Mechanical Failure of Dental Implant Nos
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyndon F Cooper, DDS, PhD principal investigator
University of Illinois at Chicago College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser-Lok abutment and Standard healing abutment in people with Dental Implant Failure Nos, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular profiling of peri-implant mucosal tissues (time frame: 1 week, 2 week, 4 week, and 8 week after implant surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03982615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.