Immediate Dentoalveolar Restoration Compared to Bio-oss (IDRBio-oss)

May 9, 2022 updated by: Alex Nogueira Haas, Federal University of Rio Grande do Sul

Immediate Dentoalveolar Restoration Compared to Demineralized Bovine Bone in Immediate Implants Placed in Fresh Sockets With Buccal Bone Resorption: 18-months Randomized Controlled Trial

This randomised controlled trial compares the immediate dentoalveolar restoration and bovine demineralised bone in immediate implants placed in fresh sockets with buccal resorption. A total of 34 patients will be included and followed clinically and radiographically for 18 months. Patient centred outcomes will also be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uruguay
      • Montevideo, Uruguay
        • Universidad de La Republica del Uruguay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Tooth extraction indicated for teeth in anterior area between second premolars

Exclusion Criteria:

  • Diabetes and other systemic conditions that may affect osseointegration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDR
Immediate dentoalveolar restoration conducted with bone removed from the tuber
Procedure: Immediate dentoalveolar restoration
Block of bone removed from the tuber and placed in the buccal resorption of the socket together with an immediate implant
Other Names:
  • IDR
Active Comparator: Bio-oss
Bovine demineralized bone (Bio-oss Collagen) applied on the buccal resorption of the immediate implant
Procedure: Demineralized bovine bone
Block of demineralised bovine bone placed in the buccal resorption of the socket together with an immediate implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Buccal-palatal thickness
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral-health related quality of life
Time Frame: 18 months
The OHIP-14 will be applied and satisfaction will also be recorded
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Collaborators

University of the Republic, Uruguay

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

June 26, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 28, 2017

Study Record Updates

Last Update Posted (Actual)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Udelar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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