Facial Mucosal Level Determinants for Single Immediately Placed Implants Evaluated by Novel Ultrasonography
12 février 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
28
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Michigan
-
Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan School of Dentistry
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Subjects who had a single implant restoration in the maxillary anterior position with sufficient baseline data will be recruited for this study.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Transversale
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mucosal recession on the tested implant
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Crown contour of the tested implant
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Hsun-Liang Chan, DDS, MS, Department of Periodontics and Oral Medicine University of Michigan School of Dentistry
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
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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.
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- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
7 août 2018
Achèvement primaire (Réel)
22 janvier 2019
Achèvement de l'étude (Réel)
22 janvier 2019
Dates d'inscription aux études
Première soumission
18 mai 2018
Première soumission répondant aux critères de contrôle qualité
13 juin 2018
Première publication (Réel)
15 juin 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 février 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 février 2019
Dernière vérification
1 février 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HUM00139630
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Indécis
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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