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

NCT03572244 | Completed Results DMC FDA Device

• 1 other identifier: 201507837
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Implants

Keywords

Laser-Lok; Crevicular fluid; Machined; Abutment

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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

Study Arms (2)

Laser-Lok

EXPERIMENTAL

A Laser-Lok microgrooved implant will be placed.

Device: Laser-Lok

Machine

ACTIVE COMPARATOR

A machined implant will be placed.

Device: Machined

Interventions

Laser-Lok DEVICE

A microgrooved abutment will be placed

Laser-Lok

Machined DEVICE

A machined transmucosal healing abutment will be placed

Machine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christopher Barwacz: lead
• BioHorizons, Inc.: collaborator

Related Publications (26)

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Limitations and Caveats

One of the primary limitations is the small sample size (n=12).

Results Point of Contact

• Title: Dr. Chris Barwacz
• Organization: University of Iowa

chris-barwacz@uiowa.edu

3193843002

Study Officials

• Chris Barwacz, DDS

  The University of Iowa College of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 28, 2018
• Study Start: January 13, 2016
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: January 3, 2022
• Results First Posted: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share