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Clinical Trials/NCT03479333
NCT03479333
Unknown
Not Applicable

Short vs Standard Implants in Maxilla: a Randomized Clinical Trial

Federal University of Pelotas1 site in 1 country50 target enrollmentApril 1, 2018
ConditionsDental Implant

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implant
Sponsor
Federal University of Pelotas
Enrollment
50
Locations
1
Primary Endpoint
implant survival
Last Updated
7 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
April 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Pelotas
Responsible Party
Principal Investigator
Principal Investigator

Maximiliano Sergio Cenci

Professor

Federal University of Pelotas

Eligibility Criteria

Inclusion Criteria

  • good general and dental health;
  • minimum of 6 mm bone width (BP);
  • bone height in sinus region between 5 and 9 mm;
  • bilateral posterior occlusal contact.

Exclusion Criteria

  • removable or partial denture;
  • patient with systemic disease treatment in course;
  • pregnant women;
  • recent extraction at the site to receive the implant.

Outcomes

Primary Outcomes

implant survival

Time Frame: five months after the implant placement

survival will be evaluated by osseointegration presence.

Study Sites (1)

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