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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03352284
Study type Interventional
Source Basque Country University
Contact
Status Completed
Phase N/A
Start date May 1, 2014
Completion date December 31, 2020

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT06314425 - Zirconia Implants: Practice-based Evidence N/A
Recruiting NCT04598776 - PMCF Study of CeraRoot Ceramic Implants One-piece: 1year, 5 Years Follow up