Replacement of Individual Teeth in the Esthetic Zone of Upper Jaw by Using a Monoblock Ceramic Implant: One Year Follow up
Sponsor study identifier
interventional
30
1 country
1
Study Start
May 1, 2014
Actual (reported)Primary Completion
December 31, 2019
Actual (reported)Study Completion
December 31, 2020
Actual (reported)The main objective is to evaluate peri-implant hard and soft tissues's stability with the use of a ceramic implant (Implant Straumann®Pure Ceramic) during one year follow up.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2014
Actual (reported)November 19, 2017
Actual (reported)November 24, 2017
Actual (reported)December 31, 2019
Actual (reported)December 31, 2020
Actual (reported)Marginal bone level change (MBLC)
Distance between the mesial/distal marginal crests and the first implant thread. This is calibrated based on the known length (1,8 mm) of the machined neck.
Change from baseline until 12 months
Gingival recession (REC)
Change from baseline (when the crown is cemented) until 12 months.
Jemt Papilla index score (JPIS)
Change from baseline until 12 months.
Surgical complications (SC)
Surgery and the next 7 days.
Prosthetic complications (PC)
Baseline, 4, 8 and 12 months.
Probing depth (PD)
Baseline, 4, 8 and 12 months.
Replacement of single tooth gaps with a Zirconia implant
The surgical technique begins with the lift of a vestibular mucoperiosteal flap respecting the papillae of the adjacent teeth. After the alveolar bone is exposed, the sequence of drilling and placement of the intra-bone fixation are carried out. In case of fenestrations or dehiscence, they are treated by xenograft and collagen-absorbable membrane. Once the implant is placed, a healing cap or provisional prosthesis is placed depending on the torque achieved. Finally, the flap is replaced and sutured.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country
Leioa, Biscay, 48940, Spain
Gahlert M, Roehling S, Sprecher CM, Kniha H, Milz S, Bormann K. In vivo performance of zirconia and titanium implants: a histomorphometric study in mini pig maxillae. Clin Oral Implants Res. 2012 Mar;23(3):281-6. doi: 10.1111/j.1600-0501.2011.02157.x. Epub 2011 Aug 2.
Kohal RJ, Knauf M, Larsson B, Sahlin H, Butz F. One-piece zirconia oral implants: one-year results from a prospective cohort study. 1. Single tooth replacement. J Clin Periodontol. 2012 Jun;39(6):590-7. doi: 10.1111/j.1600-051X.2012.01876.x. Epub 2012 Apr 23.
Luis Antonio Aguirre Zorzano, Dr.
University of the Basque Country (UPV/EHU)
Luis Barbier Herrero, Dr.
University of the Basque Country (UPV/EHU)
Miren Vilor Fernández, Lcda.
University of the Basque Country (UPV/EHU)
Ana Maria García de la Fuente, Dr.
University of the Basque Country (UPV/EHU)
30 participants (actual enrollment reported by the registry).
First Submitted
November 19, 2017
First Posted
November 24, 2017
Study Start
May 1, 2014
Actual (reported)Contact the study team to confirm eligibility.
Payer M, Arnetzl V, Kirmeier R, Koller M, Arnetzl G, Jakse N. Immediate provisional restoration of single-piece zirconia implants: a prospective case series - results after 24 months of clinical function. Clin Oral Implants Res. 2013 May;24(5):569-75. doi: 10.1111/j.1600-0501.2012.02425.x. Epub 2012 Feb 15.
Gahlert M, Burtscher D, Pfundstein G, Grunert I, Kniha H, Roehling S. Dental zirconia implants up to three years in function: a retrospective clinical study and evaluation of prosthetic restorations and failures. Int J Oral Maxillofac Implants. 2013 May-Jun;28(3):896-904. doi: 10.11607/jomi.2211.
Borgonovo AE, Censi R, Vavassori V, Arnaboldi O, Maiorana C, Re D. Zirconia Implants in Esthetic Areas: 4-Year Follow-Up Evaluation Study. Int J Dent. 2015;2015:415029. doi: 10.1155/2015/415029. Epub 2015 Jun 1.
Gahlert M, Kniha H, Weingart D, Schild S, Gellrich NC, Bormann KH. A prospective clinical study to evaluate the performance of zirconium dioxide dental implants in single-tooth gaps. Clin Oral Implants Res. 2016 Dec;27(12):e176-e184. doi: 10.1111/clr.12598. Epub 2015 Apr 1.
Siddiqi A, Kieser JA, De Silva RK, Thomson WM, Duncan WJ. Soft and Hard Tissue Response to Zirconia versus Titanium One-Piece Implants Placed in Alveolar and Palatal Sites: A Randomized Control Trial. Clin Implant Dent Relat Res. 2015 Jun;17(3):483-96. doi: 10.1111/cid.12159. Epub 2013 Sep 23.
Hashim D, Cionca N, Courvoisier DS, Mombelli A. A systematic review of the clinical survival of zirconia implants. Clin Oral Investig. 2016 Sep;20(7):1403-17. doi: 10.1007/s00784-016-1853-9. Epub 2016 May 24.
Linares A, Grize L, Munoz F, Pippenger BE, Dard M, Domken O, Blanco-Carrion J. Histological assessment of hard and soft tissues surrounding a novel ceramic implant: a pilot study in the minipig. J Clin Periodontol. 2016 Jun;43(6):538-46. doi: 10.1111/jcpe.12543. Epub 2016 May 2.
Gahlert M, Rohling S, Wieland M, Eichhorn S, Kuchenhoff H, Kniha H. A comparison study of the osseointegration of zirconia and titanium dental implants. A biomechanical evaluation in the maxilla of pigs. Clin Implant Dent Relat Res. 2010 Dec;12(4):297-305. doi: 10.1111/j.1708-8208.2009.00168.x.
Oliva J, Oliva X, Oliva JD. Five-year success rate of 831 consecutively placed Zirconia dental implants in humans: a comparison of three different rough surfaces. Int J Oral Maxillofac Implants. 2010 Mar-Apr;25(2):336-44.
Sicilia A, Cuesta S, Coma G, Arregui I, Guisasola C, Ruiz E, Maestro A. Titanium allergy in dental implant patients: a clinical study on 1500 consecutive patients. Clin Oral Implants Res. 2008 Aug;19(8):823-35. doi: 10.1111/j.1600-0501.2008.01544.x.
Grassi FR, Capogreco M, Consonni D, Bilardi G, Buti J, Kalemaj Z. Immediate occlusal loading of one-piece zirconia implants: five-year radiographic and clinical evaluation. Int J Oral Maxillofac Implants. 2015 May-Jun;30(3):671-80. doi: 10.11607/jomi.3831.
Thoma DS, Benic GI, Munoz F, Kohal R, Sanz Martin I, Cantalapiedra AG, Hammerle CH, Jung RE. Marginal bone-level alterations of loaded zirconia and titanium dental implants: an experimental study in the dog mandible. Clin Oral Implants Res. 2016 Apr;27(4):412-20. doi: 10.1111/clr.12595. Epub 2015 Apr 10.
Ruth Estefanía Fresco, Dr.
University of the Basque Country (UPV/EHU)
Xabier Marichalar Mendia, Dr.
University of the Basque Country (UPV/EHU)
Elena Ruiz de Gopegui Palacios, Lcda.
University of the Basque Country (UPV/EHU)
Primary Completion
December 31, 2019
Actual (reported)Study Completion
December 31, 2020
Actual (reported)Last Updated
July 22, 2021
Record last verified: 2021-07
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