Short vs Standard Implants in Maxilla

Short vs Standard Implants in Maxilla: a Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Dental Implant
• Intervention / Treatment: Device: Short implant; Device: Standard implant with sinus lift

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Pelotas, RS, Brazil, 96015560
      • Recruiting
      • Federal University of Pelotas - School of Dentistry
      • Contact: Tatiana Pereira-Cenci, PhD; Phone Number: 134 +555332256741; Email: tatiana.dds@ufpel.tche.br
      • Contact: Bruna M Vetromilla, MS; Phone Number: +55 53 981110520; Email: bvetromilla@gmail.com
      • Sub-Investigator: Victório Poletto-Neto, MSc
      • Principal Investigator: Tatiana Pereira-Cenci, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short implant	Device: 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.
Active Comparator: standard implant with sinus lift	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implant survival	survival will be evaluated by osseointegration presence.	five months after the implant placement

Collaborators and Investigators

• Sponsor: Federal University of Pelotas

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 14, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PPGO025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No