Dental ImplantsNCT03572244
Comparing Pro-Inflammatory Cytokines and Bone Metabolism Mediators Around Laser-Lok and Machined Transmucosal Abutments
A study testing Laser-Lok and Machined in people with Dental Implants, run by Christopher Barwacz.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants
- What is being tested?
- Laser-Lok and Machined
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2016to 24 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Implants
- Being tested
- Laser-Lok, Machined
- Keywords
- Laser-Lok, Crevicular fluid, Machined, Abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser-LokDevice
A microgrooved abutment will be placed
MachinedDevice
A machined transmucosal healing abutment will be placed
| Study group | Role | What they receive |
|---|---|---|
| Laser-Lok | Experimental | A Laser-Lok microgrooved implant will be placed. Receives: Device: Laser-Lok |
| Machine | Active comparator | A machined implant will be placed. Receives: Device: Machined |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start13 Jan 2016
- Primary completion24 May 2019
- Study completion24 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- 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
- 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.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Barwacz
- Sponsor type
- University, hospital or other
- Collaborators
- BioHorizons, Inc.
- Responsible party
- Sponsor-investigator, Christopher Barwacz, University of Iowa
- Investigators
- Chris Barwacz, DDS, Principal investigator, The University of Iowa College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572244
- Sponsor's protocol ID
- 201507837
- Status last verified
- Dec 2021
- First submitted
- 19 Jun 2018
- Last updated
- 3 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Nevins M, Nevins ML, Camelo M, Boyesen JL, Kim DM. Human histologic evidence of a connective tissue attachment to a dental implant. Int J Periodontics Restorative Dent. 2008 Apr;28(2):111-21.
PubMed 18546807Pecora GE, Ceccarelli R, Bonelli M, Alexander H, Ricci JL. Clinical evaluation of laser microtexturing for soft tissue and bone attachment to dental implants. Implant Dent. 2009 Feb;18(1):57-66. doi: 10.1097/ID.0b013e31818c5a6d.
PubMed 19212238Shapoff CA, Lahey B, Wasserlauf PA, Kim DM. Radiographic analysis of crestal bone levels around Laser-Lok collar dental implants. Int J Periodontics Restorative Dent. 2010 Apr;30(2):129-37.
PubMed 20228972Botos S, Yousef H, Zweig B, Flinton R, Weiner S. The effects of laser microtexturing of the dental implant collar on crestal bone levels and peri-implant health. Int J Oral Maxillofac Implants. 2011 May-Jun;26(3):492-8.
PubMed 21691595Geurs NC, Geisinger ML, Vassilopoulos PJ, O'Neal SJ, Haigh SJ, Reddy MS. Optimizing Connective Tissue Integration on Laser-Ablated Implant Abutments. Clin Adv Periodontics. 2016 Aug;6(3):153-159. doi: 10.1902/cap.2016.150068.
PubMed 31535464Nevins M, Camelo M, Nevins ML, Schupbach P, Kim DM. Connective tissue attachment to laser-microgrooved abutments: a human histologic case report. Int J Periodontics Restorative Dent. 2012 Aug;32(4):385-92.
PubMed 22577643Nevins M, Nevins M, Gobbato L, Lee HJ, Wang CW, Kim DM. Maintaining interimplant crestal bone height via a combined platform-switched, Laser-Lok implant/abutment system: a proof-of-principle canine study. Int J Periodontics Restorative Dent. 2013 May-Jun;33(3):261-7. doi: 10.11607/prd.1773.
PubMed 23593619Norton MR. Understanding the intimate relationship between biomechanics and optimal clinical performance: application of implant design. Compend Contin Educ Dent. 2002 Sep;23(9 Suppl 2):21-5.
PubMed 12790010Steigenga JT, al-Shammari KF, Nociti FH, Misch CE, Wang HL. Dental implant design and its relationship to long-term implant success. Implant Dent. 2003;12(4):306-17. doi: 10.1097/01.id.0000091140.76130.a1.
PubMed 14752967Stanford CM. Biomechanical and functional behavior of implants. Adv Dent Res. 1999 Jun;13:88-92. doi: 10.1177/08959374990130012101.
PubMed 11276753Ratner BD. Replacing and renewing: synthetic materials, biomimetics, and tissue engineering in implant dentistry. J Dent Educ. 2001 Dec;65(12):1340-7.
PubMed 11780652Lowney JJ, Norton LA, Shafer DM, Rossomando EF. Orthodontic forces increase tumor necrosis factor alpha in the human gingival sulcus. Am J Orthod Dentofacial Orthop. 1995 Nov;108(5):519-24. doi: 10.1016/s0889-5406(95)70052-8.
PubMed 7484971Fiorellini JP, Nevins ML, Sekler J, Chung A, Oringer RJ. Correlation of peri-implant health and aspartate aminotransferase levels: a cross-sectional clinical study. Int J Oral Maxillofac Implants. 2000 Jul-Aug;15(4):500-4.
PubMed 10960982Nowzari H, Botero JE, DeGiacomo M, Villacres MC, Rich SK. Microbiology and cytokine levels around healthy dental implants and teeth. Clin Implant Dent Relat Res. 2008 Sep;10(3):166-73. doi: 10.1111/j.1708-8208.2007.00076.x. Epub 2008 Jan 24.
PubMed 18218050Nowzari H, Phamduong S, Botero JE, Villacres MC, Rich SK. The profile of inflammatory cytokines in gingival crevicular fluid around healthy osseointegrated implants. Clin Implant Dent Relat Res. 2012 Aug;14(4):546-52. doi: 10.1111/j.1708-8208.2010.00299.x. Epub 2010 Jul 17.
PubMed 20662860
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pro-Inflammatory Cytokines and Bone Metabolism Mediators Around Laser-Lok and Machined Transmucosal Abutments: A Pilot, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03572244
- Acronym / sponsor ID
- 201507837
- Conditions
- Dental Implants
- Keywords
- Laser-Lok, Crevicular fluid, Machined, Abutment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Christopher BarwaczUniversity, hospital or other
- Collaborators
- BioHorizons, Inc.
- Study start
- 13 Jan 2016 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 24 May 2019 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Posted 3 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Laser-Lok | Experimental | Device: Laser-LokA Laser-Lok microgrooved implant will be placed. |
| Machine | Active comparator | Device: MachinedA machined implant will be placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
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-LokA microgrooved abutment will be placed | Device | Laser-Lok |
| MachinedA machined transmucosal healing abutment will be placed | Device | Machine |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18546807Nevins M, Nevins ML, Camelo M, Boyesen JL, Kim DM. Human histologic evidence of a connective tissue attachment to a dental implant. Int J Periodontics Restorative Dent. 2008 Apr;28(2):111-21.
- Background: PubMed 19212238Pecora GE, Ceccarelli R, Bonelli M, Alexander H, Ricci JL. Clinical evaluation of laser microtexturing for soft tissue and bone attachment to dental implants. Implant Dent. 2009 Feb;18(1):57-66. doi: 10.1097/ID.0b013e31818c5a6d.
- Background: PubMed 20228972Shapoff CA, Lahey B, Wasserlauf PA, Kim DM. Radiographic analysis of crestal bone levels around Laser-Lok collar dental implants. Int J Periodontics Restorative Dent. 2010 Apr;30(2):129-37.
- Background: PubMed 21691595Botos S, Yousef H, Zweig B, Flinton R, Weiner S. The effects of laser microtexturing of the dental implant collar on crestal bone levels and peri-implant health. Int J Oral Maxillofac Implants. 2011 May-Jun;26(3):492-8.
- Background: PubMed 31535464Geurs NC, Geisinger ML, Vassilopoulos PJ, O'Neal SJ, Haigh SJ, Reddy MS. Optimizing Connective Tissue Integration on Laser-Ablated Implant Abutments. Clin Adv Periodontics. 2016 Aug;6(3):153-159. doi: 10.1902/cap.2016.150068.
- Background: PubMed 22577643Nevins M, Camelo M, Nevins ML, Schupbach P, Kim DM. Connective tissue attachment to laser-microgrooved abutments: a human histologic case report. Int J Periodontics Restorative Dent. 2012 Aug;32(4):385-92.
- Background: PubMed 23593619Nevins M, Nevins M, Gobbato L, Lee HJ, Wang CW, Kim DM. Maintaining interimplant crestal bone height via a combined platform-switched, Laser-Lok implant/abutment system: a proof-of-principle canine study. Int J Periodontics Restorative Dent. 2013 May-Jun;33(3):261-7. doi: 10.11607/prd.1773.
- Background: PubMed 12790010Norton MR. Understanding the intimate relationship between biomechanics and optimal clinical performance: application of implant design. Compend Contin Educ Dent. 2002 Sep;23(9 Suppl 2):21-5.
- Background: PubMed 14752967Steigenga JT, al-Shammari KF, Nociti FH, Misch CE, Wang HL. Dental implant design and its relationship to long-term implant success. Implant Dent. 2003;12(4):306-17. doi: 10.1097/01.id.0000091140.76130.a1.
- Background: PubMed 11276753Stanford CM. Biomechanical and functional behavior of implants. Adv Dent Res. 1999 Jun;13:88-92. doi: 10.1177/08959374990130012101.
- Background: PubMed 11780652Ratner BD. Replacing and renewing: synthetic materials, biomimetics, and tissue engineering in implant dentistry. J Dent Educ. 2001 Dec;65(12):1340-7.
- Background: PubMed 7484971Lowney JJ, Norton LA, Shafer DM, Rossomando EF. Orthodontic forces increase tumor necrosis factor alpha in the human gingival sulcus. Am J Orthod Dentofacial Orthop. 1995 Nov;108(5):519-24. doi: 10.1016/s0889-5406(95)70052-8.
- Individual participant dataSharing planned: No
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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.
Chris Barwacz, DDS principal investigator
The University of Iowa College of Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing Laser-Lok and Machined in people with Dental Implants, run by Christopher Barwacz.
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 7 inclusion and 17 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: finished, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 3 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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). The study lists 2 primary outcomes in all. 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 NCT03572244, which also lists 26 linked publications.
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 3 Jan 2022.