Short vs Standard Implants in Maxilla

NCT ID: NCT03479333

Last Updated: 2018-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2020-04-30

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.

Conditions

Dental Implant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Short implant

Group Type: EXPERIMENTAL

Short implant

Intervention Type: DEVICE

Short 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.

standard implant with sinus lift

Group Type: ACTIVE_COMPARATOR

Standard implant with sinus lift

Intervention Type: DEVICE

First, 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.

Interventions

Short implant

Short 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.

Intervention Type: DEVICE

Standard implant with sinus lift

First, 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Pelotas

OTHER

Sponsor Role: lead

Responsible Party

Maximiliano Sergio Cenci

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Pelotas - School of Dentistry

Pelotas, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Tatiana Pereira-Cenci, PhD

Role: primary

tatiana.dds@ufpel.tche.br

+555332256741 ext. 134

Bruna M Vetromilla, MS

Role: backup

bvetromilla@gmail.com

+55 53 981110520

Other Identifiers

PPGO025

Identifier Type: -

Identifier Source: org_study_id