Short vs Standard Implants in Maxilla

NCT03479333 | Unknown

• 1 other identifier: PPGO025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• implant survival

  survival will be evaluated by osseointegration presence.

  five months after the implant placement

Study Arms (2)

Short implant

EXPERIMENTAL

Device: Short implant

standard implant with sinus lift

ACTIVE COMPARATOR

Device: Standard implant with sinus lift

Interventions

Short implant 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.

Short implant

Standard implant with sinus lift 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.

standard implant with sinus lift

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Federal University of Pelotas - School of Dentistry

Pelotas, Rio Grande do Sul, 96015560, Brazil

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 27, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2020
• Last Updated: November 15, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)