Clinical trial NCT03572244: Comparing Pro-Inflammatory Cytokines and Bone Metabolism Mediators Around Laser-Lok and Machined Transmucosal Abutments
Official title: Comparison of Pro-Inflammatory Cytokines and Bone Metabolism Mediators Around Laser-Lok and Machined Transmucosal Abutments: A Pilot, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Keywords: Laser-Lok
Crevicular fluid
Machined
Abutment
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: BioHorizons, Inc.
First posted: 2018-06-28
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 6 subjects will be randomized to Laser-Lok placement, and 6 subjects will be randomized to machined healing abutment placement. The assignment will be a 1:1 scheme, with the study coordinator randomly opening pre-assigned envelopes to determine implant.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 8 weeks after implant placement
measure: 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
timeFrame: 8 weeks after implant placement
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The University of Iowa College of Dentistry
name: Chris Barwacz, DDS
role: PRINCIPAL_INVESTIGATOR
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