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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.
Nowadays, the material of choice for the manufacture of dental implants is titanium. However, if we consider the aesthetics, the use of metallic implants can lead to complications, namely metal translucency through the peri-implant mucosa or the presence of soft tissue recessions causing metal exposure. As an alternative to the use of titanium, we have zirconium, that is highly biocompatible and whose use in implantology has demonstrated a predictable osseointegration. In addition, some studies suggest a different histology that could help maintaining the stability of the peri-implant mucosa and, therefore, an improvement in long-term aesthetic results.
The reason for designing this study is that there is not too much data about this type of implants, that can be, really, an alternative to those we know.
To achieve those objectives a single-arm clinical trial is designed, using marginal bone loss as a primary response variable. It is estimated with the calculation of the sample size, we would need 30 patients to get relevant data.
An experienced surgeon (M.V) will perform implant surgery. Later, experienced and calibrated examiners (R.E and E.RG) will collect the following clinical parameters at baseline, and at 4, 8 and 12 months: gingival recession, papillary Jemt index, width and height of the keratinized gingiva, probing depth, plaque index and bleeding on probing.
Finally, a blind statistic (X.M) will analyze the data using the SPSS software, having as unit of analysis the implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Straumann Pure Ceramic Implant | Experimental | Replacement of single tooth gaps with a Zirconia implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Straumann Pure Ceramic Implant | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival recession (REC) | Distance in mm from incisal edge to gingival margin. | Change from baseline (when the crown is cemented) until 12 months. |
| Jemt Papilla index score (JPIS) | This score ranges from 0 to 3. Index score 0 denotes no soft tissue in the area; index score 1 denotes soft tissue reaching less than half the distance between the reference line and the contact point; index score 2 denotes more soft tissue than indicated by index score 1 but not extending all the way to the contact point; and index score 3 denotes tissue filling the entire embrasure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Antonio Aguirre Zorzano, Dr. | University of the Basque Country (UPV/EHU) | Study Director |
| Luis Barbier Herrero, Dr. | University of the Basque Country (UPV/EHU) | Study Director |
| Miren Vilor Fernández, Lcda. | University of the Basque Country (UPV/EHU) | Principal Investigator |
| Ana Maria GarcÃa de la Fuente, Dr. | University of the Basque Country (UPV/EHU) | Study Chair |
| Ruth EstefanÃa Fresco, Dr. | University of the Basque Country (UPV/EHU) | Study Chair |
| Xabier Marichalar Mendia, Dr. | University of the Basque Country (UPV/EHU) | Study Chair |
| Elena Ruiz de Gopegui Palacios, Lcda. | University of the Basque Country (UPV/EHU) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country | Leioa | Biscay | 48940 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21806681 | Background | 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. | |
| 22519944 | Background | 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. |
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|
| Change from baseline until 12 months. |
| Surgical complications (SC) | Any complication, as bleeding, dehiscence, loss of suture, etc... that may appear will be collected. | Surgery and the next 7 days. |
| Prosthetic complications (PC) | Any difficulty during the confection of the crown, complications as descementation, chipping, etc... will be registered. | Baseline, 4, 8 and 12 months. |
| Probing depth (PD) | Distance in mm from the gingival margin to the bottom of peri-implant pocket. It will be recorded in 6 points (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual). | Baseline, 4, 8 and 12 months. |
| Bleeding on probing (BOP) | Presence or not of bleeding after probing. It will be recorded in 6 points (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual). | Baseline, 4, 8 and 12 months. |
| Plaque index (PI) | A plaque developer is used and the presence of plaque is recorded at 6 points per tooth/implant and the percentage of sites with plaque is calculated (O'Leary et al 1972). | Baseline, 4, 8 and 12 months. |
| Width of keratinized tissue (WKT) | Distance in mm from the mucogingival junction to the gingival margin, measured at the vestibular midpoint. | Baseline and 12 months. |
| Thickness of keratinized tissue (TKT) | The thickness of the gingiva around the implant is measured approximately 2 mm apical to gingival margin on the facial aspect of the implant. After topical application of anesthetic, the thickness is measured by gently inserting a 27-gauge needle with a rubber stopper in the tip until the underlying hard structure had been contacted. The distance between the tip of the needle and the rubber stopper is measure with a periodontal probe. | Baseline and 12 months |
| 22335358 | Background | 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. |
| 23748325 | Background | 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. |
| 26124836 | Background | 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. |
| 25827600 | Background | 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. |
| 24112624 | Background | 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. |
| 27217032 | Background | 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. |
| 26969899 | Background | 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. |
| 19438936 | Background | 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. |
| 20369093 | Background | 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. |
| 18705814 | Background | 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. |
| 26009919 | Background | 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. |
| 25864523 | Background | 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. |