- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03558282
Facial Mucosal Level Determinants for Single Immediately Placed Implants Evaluated by Novel Ultrasonography
A single center, prospective clinical trial is planned to investigate the effect of different emergence angles of implant restorations on peri-implant soft tissue recession and implant marginal bone loss.
The primary outcome is to systematically evaluate the association of implant-, peri-implant tissue-, and restoration-related factors with facial mucosal level changes.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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-
Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- University of Michigan School of Dentistry
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Subjects 18 years old or older
- One immediate maxillary implant placement with 2 adjacent neighboring teeth
- Available pre-surgery model
- Radiographic documentation (either peri-apical x-rays or CBCT)
- Have final restoration for at least 6 months.
Exclusion Criteria:
- Are under 18 years of age.
- Are unwilling or unable to read and sign this informed consent document.
- Have any medical conditions that we believe may influence the outcome of the study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Maxillary Anterior Implant
Subjects who have a single implant restoration in the maxillary anterior position with sufficient baseline data.
Recession observation and crown contour observation of the implant will be completed.
|
Soft tissue measurements
Ultrasound measures of implant crown contour.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mucosal recession on the tested implant
Tidsramme: At least 12 months following implant placement.
|
It is a one-time measurement (this study is only one-time visit) within the study timeframe, measured from a reference, adjacent tooth landmark, to the mucosal margin of the implant.
|
At least 12 months following implant placement.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Crown contour of the tested implant
Tidsramme: At least 12 months following implant placement.
|
It is a one-time measurement (this study is only one-time visit) within the study timeframe.
It is measured on ultrasound images.
It is the angle between the tangent line of the implant crown and implant fixture.
|
At least 12 months following implant placement.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Hsun-Liang Chan, DDS, MS, Department of Periodontics and Oral Medicine University of Michigan School of Dentistry
Publikasjoner og nyttige lenker
Generelle publikasjoner
- De Bruyckere T, Eghbali A, Younes F, De Bruyn H, Cosyn J. Horizontal stability of connective tissue grafts at the buccal aspect of single implants: a 1-year prospective case series. J Clin Periodontol. 2015 Sep;42(9):876-882. doi: 10.1111/jcpe.12448. Epub 2015 Sep 16.
- Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
- Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334.
- Katafuchi M, Weinstein BF, Leroux BG, Chen YW, Daubert DM. Restoration contour is a risk indicator for peri-implantitis: A cross-sectional radiographic analysis. J Clin Periodontol. 2018 Feb;45(2):225-232. doi: 10.1111/jcpe.12829. Epub 2017 Dec 5.
- Grunder U, Gracis S, Capelli M. Influence of the 3-D bone-to-implant relationship on esthetics. Int J Periodontics Restorative Dent. 2005 Apr;25(2):113-9.
- Dierens M, de Bruecker E, Vandeweghe S, Kisch J, de Bruyn H, Cosyn J. Alterations in soft tissue levels and aesthetics over a 16-22 year period following single implant treatment in periodontally-healthy patients: a retrospective case series. J Clin Periodontol. 2013 Mar;40(3):311-8. doi: 10.1111/jcpe.12049. Epub 2013 Jan 9.
- Abduo J. Axial Tooth Contour Alteration Following Fixed Prosthodontic Treatment. Eur J Prosthodont Restor Dent. 2014 Dec;22(4):174-82.
- Berglundh T, Abrahamsson I, Welander M, Lang NP, Lindhe J. Morphogenesis of the peri-implant mucosa: an experimental study in dogs. Clin Oral Implants Res. 2007 Feb;18(1):1-8. doi: 10.1111/j.1600-0501.2006.01380.x.
- Bichacho N, Landsberg CJ. Single implant restorations: prosthetically induced soft tissue topography. Pract Periodontics Aesthet Dent. 1997 Sep;9(7):745-52; quiz 754.
- Canullo L, Tallarico M, Radovanovic S, Delibasic B, Covani U, Rakic M. Distinguishing predictive profiles for patient-based risk assessment and diagnostics of plaque induced, surgically and prosthetically triggered peri-implantitis. Clin Oral Implants Res. 2016 Oct;27(10):1243-1250. doi: 10.1111/clr.12738. Epub 2015 Nov 20.
- Chan HL, Garaicoa-Pazmino C, Suarez F, Monje A, Benavides E, Oh TJ, Wang HL. Incidence of implant buccal plate fenestration in the esthetic zone: a cone beam computed tomography study. Int J Oral Maxillofac Implants. 2014 Jan-Feb;29(1):171-7. doi: 10.11607/jomi.3397.
- Chan HL, Sinjab K, Chung MP, Chiang YC, Wang HL, Giannobile WV, Kripfgans OD. Non-invasive evaluation of facial crestal bone with ultrasonography. PLoS One. 2017 Feb 8;12(2):e0171237. doi: 10.1371/journal.pone.0171237. eCollection 2017.
- Chan HL, Wang HL, Fowlkes JB, Giannobile WV, Kripfgans OD. Non-ionizing real-time ultrasonography in implant and oral surgery: A feasibility study. Clin Oral Implants Res. 2017 Mar;28(3):341-347. doi: 10.1111/clr.12805. Epub 2016 Mar 19.
- Chifor R, Hedesiu M, Bolfa P, Catoi C, Crisan M, Serbanescu A, Badea AF, Moga I, Badea ME. The evaluation of 20 MHz ultrasonography, computed tomography scans as compared to direct microscopy for periodontal system assessment. Med Ultrason. 2011 Jun;13(2):120-6.
- Chu SJ, Paravina RD. Periodontal-prosthodontics in contemporary practice. J Dent. 2013 Aug;41 Suppl 3:e1-2. doi: 10.1016/j.jdent.2013.06.010. No abstract available.
- Cooper LF, Pin-Harry OC. "Rules of Six"--diagnostic and therapeutic guidelines for single-tooth implant success. Compend Contin Educ Dent. 2013 Feb;34(2):94-8, 100-1; quiz 102, 117.
- Davarpanah M, Martinez H, Tecucianu JF. Apical-coronal implant position: recent surgical proposals. Technical note. Int J Oral Maxillofac Implants. 2000 Nov-Dec;15(6):865-72.
- Du JK, Li HY, Wu JH, Lee HE, Wang CH. Emergence angles of the cementoenamel junction in natural maxillary anterior teeth. J Esthet Restor Dent. 2011 Dec;23(6):362-9. doi: 10.1111/j.1708-8240.2011.00471.x. Epub 2011 Sep 20.
- Eghbali A, De Bruyn H, Cosyn J, Kerckaert I, Van Hoof T. Ultrasonic Assessment of Mucosal Thickness around Implants: Validity, Reproducibility, and Stability of Connective Tissue Grafts at the Buccal Aspect. Clin Implant Dent Relat Res. 2016 Feb;18(1):51-61. doi: 10.1111/cid.12245. Epub 2014 Jul 17.
- Ericsson I, Lindhe J. Probing depth at implants and teeth. An experimental study in the dog. J Clin Periodontol. 1993 Oct;20(9):623-7. doi: 10.1111/j.1600-051x.1993.tb00706.x.
- Funato A, Salama MA, Ishikawa T, Garber DA, Salama H. Timing, positioning, and sequential staging in esthetic implant therapy: a four-dimensional perspective. Int J Periodontics Restorative Dent. 2007 Aug;27(4):313-23.
- Garber DA, Belser UC. Restoration-driven implant placement with restoration-generated site development. Compend Contin Educ Dent. 1995 Aug;16(8):796, 798-802, 804.
- Ishikawa T, Salama M, Funato A, Kitajima H, Moroi H, Salama H, Garber D. Three-dimensional bone and soft tissue requirements for optimizing esthetic results in compromised cases with multiple implants. Int J Periodontics Restorative Dent. 2010 Oct;30(5):503-11.
- Kois JC. Predictable single tooth peri-implant esthetics: five diagnostic keys. Compend Contin Educ Dent. 2001 Mar;22(3):199-206; quiz 208.
- Le BT, Borzabadi-Farahani A, Pluemsakunthai W. Is buccolingual angulation of maxillary anterior implants associated with the crestal labial soft tissue thickness? Int J Oral Maxillofac Surg. 2014 Jul;43(7):874-8. doi: 10.1016/j.ijom.2014.02.009. Epub 2014 Mar 15.
- Lee EA. Transitional custom abutments: optimizing aesthetic treatment in implant-supported restorations. Pract Periodontics Aesthet Dent. 1999 Nov-Dec;11(9):1027-34; quiz 1036.
- Lin GH, Chan HL, Wang HL. Effects of currently available surgical and restorative interventions on reducing midfacial mucosal recession of immediately placed single-tooth implants: a systematic review. J Periodontol. 2014 Jan;85(1):92-102. doi: 10.1902/jop.2013.130064. Epub 2013 Apr 11.
- Linkevicius T, Vindasiute E, Puisys A, Peciuliene V. The influence of margin location on the amount of undetected cement excess after delivery of cement-retained implant restorations. Clin Oral Implants Res. 2011 Dec;22(12):1379-84. doi: 10.1111/j.1600-0501.2010.02119.x. Epub 2011 Mar 8.
- Listgarten MA, Lang NP, Schroeder HE, Schroeder A. Periodontal tissues and their counterparts around endosseous implants [corrected and republished with original paging, article orginally printed in Clin Oral Implants Res 1991 Jan-Mar;2(1):1-19]. Clin Oral Implants Res. 1991 Jul-Sep;2(3):1-19. doi: 10.1034/j.1600-0501.1991.020309.x. No abstract available.
- Muller HP, Barrieshi-Nusair KM, Kononen E. Repeatability of ultrasonic determination of gingival thickness. Clin Oral Investig. 2007 Dec;11(4):439-42. doi: 10.1007/s00784-007-0125-0. Epub 2007 May 24.
- Muller HP, Schaller N, Eger T. Ultrasonic determination of thickness of masticatory mucosa: a methodologic study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999 Aug;88(2):248-53. doi: 10.1016/s1079-2104(99)70123-x.
- Nguyen KC, Le LH, Kaipatur NR, Major PW. Imaging the Cemento-Enamel Junction Using a 20-MHz Ultrasonic Transducer. Ultrasound Med Biol. 2016 Jan;42(1):333-8. doi: 10.1016/j.ultrasmedbio.2015.09.012. Epub 2015 Nov 3.
- Nguyen KT, Le LH, Kaipatur NR, Zheng R, Lou EH, Major PW. High-Resolution Ultrasonic Imaging of Dento-Periodontal Tissues Using a Multi-Element Phased Array System. Ann Biomed Eng. 2016 Oct;44(10):2874-2886. doi: 10.1007/s10439-016-1634-2. Epub 2016 May 9.
- Palou ME, McQuade MJ, Rossmann JA. The use of ultrasound for the determination of periodontal bone morphology. J Periodontol. 1987 Apr;58(4):262-5. doi: 10.1902/jop.1987.58.4.262.
- Rompen E, Raepsaet N, Domken O, Touati B, Van Dooren E. Soft tissue stability at the facial aspect of gingivally converging abutments in the esthetic zone: a pilot clinical study. J Prosthet Dent. 2007 Jun;97(6 Suppl):S119-25. doi: 10.1016/S0022-3913(07)60015-8. Erratum In: J Prosthet Dent. 2008 Mar;99(3):167.
- Saker S, El-Shahat S, Ghazy M. Fracture Resistance of Straight and Angulated Zirconia Implant Abutments Supporting Anterior Three-Unit Lithium Disilicate Fixed Dental Prostheses. Int J Oral Maxillofac Implants. 2016 Nov/Dec;31(6):1240-1246. doi: 10.11607/jomi.4131.
- Scutella F, Weinstein T, Lazzara R, Testori T. Buccolingual implant position and vertical abutment finish line geometry: two strictly related factors that may influence the implant esthetic outcome. Implant Dent. 2015 Jun;24(3):343-8. doi: 10.1097/ID.0000000000000235.
- Smukler H, Castellucci F, Capri D. The role of the implant housing in obtaining aesthetics: generation of peri-implant gingivae and papillae--Part 1. Pract Proced Aesthet Dent. 2003 Mar;15(2):141-9; quiz 150.
- Spray JR, Black CG, Morris HF, Ochi S. The influence of bone thickness on facial marginal bone response: stage 1 placement through stage 2 uncovering. Ann Periodontol. 2000 Dec;5(1):119-28. doi: 10.1902/annals.2000.5.1.119.
- Steigmann M, Monje A, Chan HL, Wang HL. Emergence profile design based on implant position in the esthetic zone. Int J Periodontics Restorative Dent. 2014 Jul-Aug;34(4):559-63. doi: 10.11607/prd.2016.
- Su H, Gonzalez-Martin O, Weisgold A, Lee E. Considerations of implant abutment and crown contour: critical contour and subcritical contour. Int J Periodontics Restorative Dent. 2010 Aug;30(4):335-43.
- Thoma DS, Sanz Martin I, Benic GI, Roos M, Hammerle CH. Prospective randomized controlled clinical study comparing two dental implant systems: demographic and radiographic results at one year of loading. Clin Oral Implants Res. 2014 Feb;25(2):142-9. doi: 10.1111/clr.12120. Epub 2013 Feb 19.
- Tsiolis FI, Needleman IG, Griffiths GS. Periodontal ultrasonography. J Clin Periodontol. 2003 Oct;30(10):849-54. doi: 10.1034/j.1600-051x.2003.00380.x.
- Tzoumpas M, Mohr B, Kurtulus-Waschulewski I, Wahl G. The Use of High-Frequency Ultrasound in the Measurement of Thickness of the Maxillary Attached Gingiva. Int J Prosthodont. 2015 Jul-Aug;28(4):374-82. doi: 10.11607/ijp.4250.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
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