Comparing Pro-Inflammatory Cytokines and Bone Metabolism Mediators Around Laser-Lok and Machined Transmucosal Abutments

December 2, 2021 updated by: Christopher Barwacz

Comparison of Pro-Inflammatory Cytokines and Bone Metabolism Mediators Around Laser-Lok and Machined Transmucosal Abutments: A Pilot, Randomized Clinical Trial

A pilot, prospective, randomized clinical trial is proposed. It is primarily aimed at assessing the expression of pro-inflammatory cytokine and bone metabolism mediators adjacent to Laser-Lok microgrooved (LL) or machined (M) transmucosal healing abutments. The pilot study would seek recruitment of 12 subjects requiring replacement of a single, toothbound molar or premolar in the maxilla or mandible with an implant-supported restoration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research study is to compare two different implant abutment designs, microgrooved and machined. The implant abutment is the dental prosthetic part that connects the implant to the crown. As a part of this study, subjects will have a dental implant surgically placed in their jaw bone. The implant will serve as the artificial root. After the implant heals, subjects will have the abutment and crown placed on the implant.

This study will compare levels of inflammation next to the implant abutment. Both implant abutment designs are FDA approved but differ in microtexturing. This study will determine if these texture differences have any impact on the healing of subjects' jaw bone and gums after implant surgery.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or greater
  • Subjects requiring the replacement of either a tooth-bound molar or premolar in either arch that do not require simultaneous implant site development (i.e., bone and/or soft-tissue grafting)
  • Teeth adjacent (mesial and distal) to study site must consist of two stable, natural teeth without signs of periodontal attachment loss up to 2.0mm
  • An opposing dentition with teeth, implants, or fixed prosthesis
  • Subjects must be willing to forgo use of a provisional appliance (e.g., removable interim partial denture (or) "flipper", essix appliance, etc.) during the active portion (from implant placement to 8 week +IP visit) of the study protocol.
  • Subjects must be willing to follow instructions related to the study procedures
  • Subjects must have read, understood, and signed the informed consent document

Exclusion Criteria:

  • Insufficient interocclusal space for implant placement and/or restoration at study site
  • Insufficient lateral ridge volume for implant placement in a prosthetically-driven location
  • More than 2.0 mm of vertical bone loss at study site as measured from the interproximal crestal bone on the adjacent teeth
  • Untreated rampant caries
  • Tobacco use free for ≤ 6 months
  • Liver or kidney dysfunction/failure
  • Active severe infectious diseases that may affect normal healing and/or bone metabolism
  • Uncontrolled diabetes determined as HbA1c value > 7%
  • Current alcohol or drug abuse
  • Need for systemic medications (e.g., corticosteroids) that may influence postoperative healing and/or osseointegration
  • History of relevant head/neck cancer and/or radiation of the head/neck within the last 24 months
  • Subjects who currently use IV bisphosphonates or have a history of IV bisphosphonate use
  • Subjects with metabolic bone diseases such as severe osteoporosis or Paget's disease of bone
  • Known pregnancy or nursing mothers
  • Unwilling to forgo use of a provisional appliance (e.g., removable interim partial denture (or) "flipper", essix appliance, etc.) during the active portion (from implant placement to 8 week +IP visit) of the study protocol.
  • Unable or unwilling to return for follow-up visits for a period of 1 year
  • Unlikely to be able to comply with study procedures according to investigators judgement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Laser-Lok
A Laser-Lok microgrooved implant will be placed.
Device: Laser-Lok
A microgrooved abutment will be placed
ACTIVE_COMPARATOR: Machine
A machined implant will be placed.
Device: Machined
A machined transmucosal healing abutment will be placed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in PICF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
Time Frame: 8 weeks after implant placement
Determine if there is a difference in peri-implant crevicular fluid's pro-inflammatory and bone-metabolism mediator profiles, specifically for peri-implant crevicular fluid that is next to Laser-Lok microgrooved (LL) and machined (M) healing abutments after a healing period of 8 weeks after implant placement.
8 weeks after implant placement
Difference in GCF Cytokine Levels (Log pg/ml) for Various Biomarkers, Specifically at Laser-Lok Abutment Sites and Machined Abutment Sites at 8 Weeks After Implant Placement
Time Frame: 8 weeks after implant placement
Determine if there is a difference in gingival crevicular fluid's pro-inflammatory and bone-metabolism mediator profiles, specifically for gingival crevicular fluid that is next to Laser-Lok microgrooved abutments (LL) and machined (M) habutments after a healing period of 8 weeks after implant placement.
8 weeks after implant placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christopher Barwacz

Collaborators

BioHorizons, Inc.

Investigators

  • Principal Investigator: Chris Barwacz, DDS, The University of Iowa College of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 13, 2016

Primary Completion (ACTUAL)

May 24, 2019

Study Completion (ACTUAL)

May 24, 2019

Study Registration Dates

First Submitted

June 19, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (ACTUAL)

June 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201507837

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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