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The study outline has been described before in the 1‐year report of Guljé et al. (2013) and the 3‐year report of Zadeh et al. (2018).

Material & methods : Comparison of 6‐mm and 11‐mm dental implants (1)

author: Felix L Gulj,Henny J A Meijer,Ingemar Abrahamsson,Christopher A Barwacz,Stephen Chen,Paul J Palmer,Homayoun Zadeh,Clark M Stanfo | publisher: drg. Andreas Tjandra, Sp. Perio, FISID

2 MATERIAL AND METHODS

2.1 Study design

The study outline has been described before in the 1‐year report of Guljé et al. (2013) and the 3‐year report of Zadeh et al. (2018). Inclusion/exclusion criteria, treatment and evaluation procedures are described in detail in these publications. The present report has been prepared in accordance with guidelines outlined in the CONSORT statement for reporting of randomized controlled trials (Moher et al., 2010). A summary of the procedures utilized in the present 5‐year evaluation is described below.

The design was an international multicenter randomized clinical trial. The study groups were:

  • 6‐mm group: patients to receive two or three 6‐mm implants (to replace two or three missing premolars/molars) and a fixed denture prosthesis (Figure 1);
  • 11‐mm group: patients to receive two or three 11‐mm implants (to replace two or three missing premolars/molars) and a fixed denture prosthesis (Figure 2).

Titanium implants (either 6 mm in length or 11 mm in length) with a diameter of 4 mm were used (OsseoSpeed implants, Dentsply Sirona Implants).

The study protocol was registered with clinicaltrials.gov (registration number NCT00545818) prior to its commencement. The study took place at six centers in six countries worldwide. All six study centers obtained approval of their institutional review boards or medical ethics committees prior to the initiation of the study. The enrollment of participants started November 2007 and the last patient was included in June 2010.

 

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