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| Name | Class |
|---|---|
| BioHorizons, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser-Lok | Experimental | A Laser-Lok microgrooved implant will be placed. |
|
| Machine | Active Comparator | A machined implant will be placed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser-Lok | Device | A microgrooved abutment will be placed |
| |
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Barwacz, DDS | The University of Iowa College of Dentistry | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18546807 | Background | 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. | |
| 19212238 | Background | Pecora 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. |
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Of the 23 enrolled participants, 12 met the inclusion criteria, were randomized to treatment, and completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Laser-Lok | A Laser-Lok microgrooved implant will be placed. Laser-Lok: A microgrooved abutment will be placed |
| FG001 | Machine | A machined implant will be placed. Machined: A machined transmucosal healing abutment will be placed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Laser-Lok | A Laser-Lok microgrooved implant will be placed. Laser-Lok: A microgrooved abutment will be placed |
| BG001 | Machine | A machined implant will be placed. Machined: A machined transmucosal healing abutment will be placed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | log pg/ml | 8 weeks after implant placement |
|
14 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laser-Lok | A Laser-Lok microgrooved implant will be placed. Laser-Lok: A microgrooved abutment will be placed |
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One of the primary limitations is the small sample size (n=12).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chris Barwacz | University of Iowa | 3193843002 | chris-barwacz@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 15, 2015 | Aug 4, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2018 | Aug 4, 2021 | SAP_001.pdf |
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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.
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| Machined |
| Device |
A machined transmucosal healing abutment will be placed |
|
| 20228972 | Background | Shapoff 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. |
| 21691595 | Background | Botos 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. |
| 31535464 | Background | Geurs 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. |
| 22577643 | Background | Nevins 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. |
| 23593619 | Background | Nevins 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. |
| 12790010 | Background | Norton 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. |
| 14752967 | Background | Steigenga 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. |
| 11276753 | Background | Stanford CM. Biomechanical and functional behavior of implants. Adv Dent Res. 1999 Jun;13:88-92. doi: 10.1177/08959374990130012101. |
| 11780652 | Background | Ratner BD. Replacing and renewing: synthetic materials, biomimetics, and tissue engineering in implant dentistry. J Dent Educ. 2001 Dec;65(12):1340-7. |
| 7484971 | Background | Lowney 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. |
| 10960982 | Background | Fiorellini 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. |
| 18218050 | Background | Nowzari 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. |
| 20662860 | Background | Nowzari 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. |
| 18384390 | Background | Schierano G, Pejrone G, Brusco P, Trombetta A, Martinasso G, Preti G, Canuto RA. TNF-alpha TGF-beta2 and IL-1beta levels in gingival and peri-implant crevicular fluid before and after de novo plaque accumulation. J Clin Periodontol. 2008 Jun;35(6):532-8. doi: 10.1111/j.1600-051X.2008.01224.x. Epub 2008 Apr 1. |
| 21806683 | Background | Salvi GE, Aglietta M, Eick S, Sculean A, Lang NP, Ramseier CA. Reversibility of experimental peri-implant mucositis compared with experimental gingivitis in humans. Clin Oral Implants Res. 2012 Feb;23(2):182-190. doi: 10.1111/j.1600-0501.2011.02220.x. Epub 2011 Aug 2. |
| 20207110 | Background | Petkovic AB, Matic SM, Stamatovic NV, Vojvodic DV, Todorovic TM, Lazic ZR, Kozomara RJ. Proinflammatory cytokines (IL-1beta and TNF-alpha) and chemokines (IL-8 and MIP-1alpha) as markers of peri-implant tissue condition. Int J Oral Maxillofac Surg. 2010 May;39(5):478-85. doi: 10.1016/j.ijom.2010.01.014. Epub 2010 Mar 5. |
| 12519339 | Background | Murata M, Tatsumi J, Kato Y, Suda S, Nunokawa Y, Kobayashi Y, Takeda H, Araki H, Shin K, Okuda K, Miyata T, Yoshie H. Osteocalcin, deoxypyridinoline and interleukin-1beta in peri-implant crevicular fluid of patients with peri-implantitis. Clin Oral Implants Res. 2002 Dec;13(6):637-43. doi: 10.1034/j.1600-0501.2002.130610.x. |
| 21306703 | Background | Severino VO, Napimoga MH, de Lima Pereira SA. Expression of IL-6, IL-10, IL-17 and IL-8 in the peri-implant crevicular fluid of patients with peri-implantitis. Arch Oral Biol. 2011 Aug;56(8):823-8. doi: 10.1016/j.archoralbio.2011.01.006. Epub 2011 Feb 8. |
| 20870421 | Background | Javed F, Al-Hezaimi K, Salameh Z, Almas K, Romanos GE. Proinflammatory cytokines in the crevicular fluid of patients with peri-implantitis. Cytokine. 2011 Jan;53(1):8-12. doi: 10.1016/j.cyto.2010.08.013. Epub 2010 Sep 25. |
| 17348886 | Background | Lachmann S, Kimmerle-Muller E, Axmann D, Scheideler L, Weber H, Haas R. Associations between peri-implant crevicular fluid volume, concentrations of crevicular inflammatory mediators, and composite IL-1A -889 and IL-1B +3954 genotype. A cross-sectional study on implant recall patients with and without clinical signs of peri-implantitis. Clin Oral Implants Res. 2007 Apr;18(2):212-23. doi: 10.1111/j.1600-0501.2006.01322.x. |
| 19081897 | Background | Andreiotelli M, Koutayas SO, Madianos PN, Strub JR. Relationship between interleukin-1 genotype and peri-implantitis: a literature review. Quintessence Int. 2008 Apr;39(4):289-98. |
| 21212999 | Background | Boynuegri AD, Yalim M, Nemli SK, Erguder BI, Gokalp P. Effect of different localizations of microgap on clinical parameters and inflammatory cytokines in peri-implant crevicular fluid: a prospective comparative study. Clin Oral Investig. 2012 Apr;16(2):353-61. doi: 10.1007/s00784-010-0497-4. Epub 2011 Jan 7. |
| 12453123 | Background | Ataoglu H, Alptekin NO, Haliloglu S, Gursel M, Ataoglu T, Serpek B, Durmus E. Interleukin-1beta, tumor necrosis factor-alpha levels and neutrophil elastase activity in peri-implant crevicular fluid. Clin Oral Implants Res. 2002 Oct;13(5):470-6. doi: 10.1034/j.1600-0501.2002.130505.x. |
| 24417614 | Background | Barwacz CA, Brogden KA, Stanford CM, Dawson DV, Recker EN, Blanchette D. Comparison of pro-inflammatory cytokines and bone metabolism mediators around titanium and zirconia dental implant abutments following a minimum of 6 months of clinical function. Clin Oral Implants Res. 2015 Apr;26(4):e35-e41. doi: 10.1111/clr.12326. Epub 2014 Jan 13. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
A machined implant will be placed.
Machined: A machined transmucosal healing abutment will be placed
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | log pg/ml | 8 weeks after implant placement |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Machine | A machined implant will be placed. Machined: A machined transmucosal healing abutment will be placed | 0 | 6 | 0 | 6 | 0 | 6 |
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| logIL8 |
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| logMMP1 |
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| logIP10 |
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| logMMP8b |
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| logIL_1B |
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| logMMP13 |
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| logENA78 |
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| logMIG |
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| logOsteopontin |
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| logITAC1 |
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| logOsteoprotegerin |
|