Clinical Trials Directory

Trials / Unknown

UnknownNCT03479333

Short vs Standard Implants in Maxilla

Short vs Standard Implants in Maxilla: a Randomized Clinical Trial

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Federal University of Pelotas · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

Summary

The prosthetic treatment with dental implants is challenging in posterior maxilla, where there is a sinus pneumatization. For the rehabilitation of patients with intermediate bone level, short implants have been used as alternative. It is also needed to look for the prosthetic context of rehabilitation with implants, like the use of different materials as abutments. The aim of this study is to compare the survival of two sizes of implants (short vs standard) placed in upper premolars region with need of bone graft, with a minimum of three years of follow-up, and assess the behavior of different abutments (titanium vs zirconia) in prosthesis in this context. This will be a randomized clinical trial with two groups: 1) standard implants and sinus lift; and 2) short implants without sinus lift. The patients who fulfill the inclusion criteria and accept to participate of this study, will be included in the randomization process. At the implant installation, a brown envelope, with the word SHORT or STANDARD, will be open, in order to determine the group. Abutment type will be also randomized. Four months after the installation, torque will be confirmed and the abutment will be installed. Implant failure and prosthesis failure in function of the abutment will be the outcomes. Data analysis will be conducted following a previously established spreadsheet using the Kaplan-Meier method and log rank test for success and survival, followed by Cox regression, if possible and according to the number of failures.

Conditions

Interventions

TypeNameDescription
DEVICEShort implantShort implant will be placed depending on the previous randomization. For that, a surgical access will be done, and the implant will be placed, cover screw will be installed and the access closed. The patient will receive the definitive crown after five months after the short implant installation.
DEVICEStandard implant with sinus liftFirst, a surgical access will be performed, followed by sinus lift procedure. Next, a standard implant will be placed, cover screw will be installed and the access closed. The patient will receive the definitive crown after five months after the short implant installation.

Timeline

Start date
2018-04-01
Primary completion
2019-04-01
Completion
2020-04-01
First posted
2018-03-27
Last updated
2018-11-15

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03479333. Inclusion in this directory is not an endorsement.