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Implant Retained Rehabilitation With Surgical and Prosthetic Digital Workflow

NCT04066309 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-11-13

No results posted yet for this study

Summary

The aim of this study is to prospectively collect clinical data to confirm the safety and clinical performance of Neodent Titanium Base Abutment and Pro PEEK Abutment in daily dental practice setting, by means of a randomized clinical study of prosthetic rehabilitation using these devices.

A total of 48 healed implant sites (at least 4 months post-extraction) shall be included during the sample enrollment (24 patients), which will be randomly divided into two groups, so that each patient receives one implant from each group (removal and non-removal of the abutment placed at the time of surgery).

Patients will be followed for 24 months after implant loading. It is expected that there is no difference in peri-implant bone level change between the two treatment groups.

Conditions

  • Jaw, Edentulous, Partially

Interventions

DEVICE

Neodent GM Helix Implant

4.0x10 mm Neodent GM Helix Implants will be placed 2mm subcrestally (in relation to the buccal bone plate) in the posterior region of the maxilla, under local anesthesia and with adequate bone bed preparation, as recommended by the manufacturer, using the guided surgery technique.

DEVICE

GM Customizable Healing Abutment

Customizable healing abutments will be placed at the time of implant placement.

DEVICE

GM Pro PEEK Abutment

Placement of temporary single prostheses (early loading), over temporary abutments.

DEVICE

GM Exact Titanium Base

Insertion of the final abutment (Titanium Base and Zirconia Coping), following the digital workflow.

Sponsors & Collaborators

  • Neodent

    lead INDUSTRY

Principal Investigators

  • Larissa Trojan, PhD · Neodent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-02
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04066309 on ClinicalTrials.gov