Facial Mucosal Level Determinants for Single Immediately Placed Implants Evaluated by Novel Ultrasonography
12 lutego 2019 zaktualizowane przez: Hsun-Liang Chan, University of Michigan
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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
Facial mucosal recession still poses a threat to long-term success of implant therapy especially esthetic appearance.
To study the timing and extent of mucosal recession and the associated risks, a prospective study is strategically important.
This will allow the collection of valuable longitudinal data about facial mucosal level changes, peri-implant tissue dimensions, and implant/restoration parameters that are considered critical for determining the mucosal level.
Forty adult patients who meet the inclusion criteria will be recruited to participate in this study.
Patients that had an implant crown placed a minimum time frame of 6 months and have existing relevant clinical data (mucosal level and thickness, radiographs, cone beam computed tomogram (CBCT) scans, study casts and intra-oral photographs) at baseline and if possible at other follow-up visits will be invited to participate in this study.
Patients that volunteer to be screened will not be examined for study eligibility until an informed consent has been obtained.
Patient information will be protected according to HIPAA.
The enrolled subjects will have research measurements taken, an ultrasound scan, intraoral photos and an impression of the arch including the study implant.
One dental cone beam computed tomography (CBCT) scan will be taken to evaluate the implant position in relation to the alveolar ridge and to evaluate relative bone quality.
The primary outcome will analyze the changes in the facial mucosal level, by superimposing the digital images of the stone models that were taken previously.
On ultrasound images, peri-implant tissue parameters, implant positions, restoration contour, etc., will be measured and recorded.
The primary outcome will then be equated with clinical and radiographic readings, and ultrasound parameters, along with timing of provisionalization or final restoration, in regression analysis to identify factors related to facial mucosal recession.
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
28
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48109
- University of Michigan School of Dentistry
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Subjects who had a single implant restoration in the maxillary anterior position with sufficient baseline data will be recruited for this study.
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Kohorta
- Perspektywy czasowe: Przekrojowe
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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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.
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Soft tissue measurements
Ultrasound measures of implant crown contour.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Mucosal recession on the tested implant
Ramy czasowe: 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.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Crown contour of the tested implant
Ramy czasowe: 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.
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Hsun-Liang Chan, DDS, MS, Department of Periodontics and Oral Medicine University of Michigan School of Dentistry
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
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- 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.
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- 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.
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
7 sierpnia 2018
Zakończenie podstawowe (Rzeczywisty)
22 stycznia 2019
Ukończenie studiów (Rzeczywisty)
22 stycznia 2019
Daty rejestracji na studia
Pierwszy przesłany
18 maja 2018
Pierwszy przesłany, który spełnia kryteria kontroli jakości
13 czerwca 2018
Pierwszy wysłany (Rzeczywisty)
15 czerwca 2018
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
15 lutego 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
12 lutego 2019
Ostatnia weryfikacja
1 lutego 2019
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HUM00139630
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Niezdecydowany
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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