Immediate vs Delayed Placement of Straumann BLX Implants in Molar Extraction Sockets

Summary

The aim of this study is to clinically and radiographically compare the success and survival of implants immediately placed in molar fresh extraction socket to delayed implant placement at least 12 weeks post molar extraction. The secondary aim is to evaluate the peri-implant tissue response around implants with immediate vs. delayed placement.

Conditions

• Immediate Placement of Straumann BLX Implants in Molar Extraction Sockets

Interventions

DEVICE

Immediate placement non-occlusal loading molar implant (Straumann BLX 6.5mm)

At the screening visit, potential subjects will be informed about the protocol and all questions related to the study will be answered. Medical and dental histories will be reviewed and physical evaluations will be performed in order to rule out local or systemic factors that would compromise the outcome of the study. A detailed extra and intra oral examination will be performed. Appropriate radiographic imaging studies will be obtained prior to the surgical visit (per the protocol of the University of Kentucky, College of Dentistry) including CBCT and intraoral scans for treatment planning implant through Straumann Guided Surgery workflow. The duration of the present study is 1 year including the baseline or surgical visit, 2-weeks postoperative visit, 12-weeks baseline for control group and postoperative evaluations at 3, and 12 months.

DEVICE

Delayed placement non-occlusal loading molar implant (Straumann BLX 5.0mm)

At the screening visit, potential subjects will be informed about the protocol and all questions related to the study will be answered. Medical and dental histories will be reviewed and physical evaluations will be performed in order to rule out local or systemic factors that would compromise the outcome of the study. A detailed extra and intra oral examination will be performed. Appropriate radiographic imaging studies will be obtained prior to the surgical visit (per the protocol of the University of Kentucky, College of Dentistry) including CBCT and intraoral scans for treatment planning implant through Straumann Guided Surgery workflow. The duration of the present study is 1 year including the baseline or surgical visit, 2-weeks postoperative visit, 12-weeks baseline for control group and postoperative evaluations at 3, and 12 months.

Sponsors & Collaborators

• Straumann USA

  collaborator UNKNOWN

• Ahmad Kutkut

  lead OTHER

Principal Investigators

• Ahmad KutKut, DDS, MS · University of Kentucky

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

22 Years

Max Age

78 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-08-01

Primary Completion

2024-06-01

Completion

2024-06-01

FDA Device

Yes

Countries

• United States

Study Locations