The Effect of Immediate Implant Placement and Provisionalization in the Esthetic Zone (3i)

June 8, 2017 updated by: Robert M. Eber, University of Michigan

The Effect of Immediate Implant Placement and Provisionalization in The Esthetic Zone: A Randomized Clinical Trial

The purpose of this study is to compare two different techniques of placing dental implants: 1) removing the tooth and placing the implant immediately and 2) removing the tooth and placing both the implant and a temporary crown immediately. Both procedures currently are accepted methods for replacing missing teeth but direct comparisons of the two procedures are lacking. The results of this study should aid clinicians in selecting the best implant placement technique for their patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

To qualify, patients must be between 18 to 79 years old, in good health, have a tooth in the upper jaw (except molars) that needs to be extracted, and able and willing to return to the University of Michigan Dental School for all follow-up appointments (8 follow-up visits over a period of 12 months). Sufficient number of natural teeth and/or replacements to provide a stable occlusion as determined by the investigator

Patients will be excluded for any of the following conditions: Women who are pregnant or plan to become pregnant, an existing implant adjacent to the area of study, current smoker or quit smoking less than one year ago, antibiotic therapy for more than two weeks within 3 months of baseline, need for antibiotics prior to dental treatment (due to prosthetic joint replacement or other medical condition), chronic use of medications known to affect the gum tissues (calcium channel blocker (less than 6 months, or over 6 months and have experienced overgrowth of your gums), anticonvulsants, immunosuppressive drugs, nonsteroidal anti-inflammatory medications...), current orthodontic treatment, or active periodontal treatment. Participants must inform the investigators if they are enrolled in any other studies because it may becloud them from participation in this study.

Study Type

Interventional

Enrollment (Actual)

5

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

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

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 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • between 18 to 79 years old
  • in good health
  • have a single tooth in the upper jaw (except molars) that needs to be extracted
  • able and willing to return to the University of Michigan Dental School for all follow-up appointments (8 follow-up visits over a period of 12 months)
  • Sufficient number of natural teeth and/or replacements to provide a stable occlusion as determined by the investigator

Exclusion Criteria:

  • an existing implant adjacent to the area of study
  • current smoker or quit smoking less than one year ago
  • antibiotic therapy for more than two weeks within 3 months of baseline, need for antibiotics prior to dental treatment (due to prosthetic joint replacement or other medical condition)
  • chronic use of medications known to affect the gum tissues (calcium channel blocker (less than 6 months, or over 6 months and have experienced overgrowth of your gums), anticonvulsants, immunosuppressive drugs, nonsteroidal anti-inflammatory medications...)
  • current orthodontic treatment, or active periodontal treatment
  • Women who are pregnant or plan to become pregnant during the course of the study, and nursing mothers
  • unstable medical condition or if you are unable to have routine dental surgery then you should not participate in this study. If you are already participating in another study, we ask that you inform the investigators because participating in more than one study may be harmful to you.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: immediate implant placement without provisionalization
The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.
Device: immediate implant placement without provisionalization
Other Names:
  • BIOMET 3i Prevail Nanotite Certain - dental implant
  • Encode abutment
Experimental: immediate implant placement with immediate provisionalization
The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.
Device: immediate implant placement with immediate provisionalization
Other Names:
  • BIOMET 3i Prevail Nanotite Certain - dental implant
  • Encode abutment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft Tissue Diemensional Change
Time Frame: Baseline, 12mo after baseline
Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.
Baseline, 12mo after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Survival
Time Frame: 2wk, 4wk, 6wk, 3mo, 6mo, 12mo
Checking to make sure the implant is stable.
2wk, 4wk, 6wk, 3mo, 6mo, 12mo

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bony Dimensional Changes
Time Frame: Baseline, 6mo & 12mo after baseline
Measurements will be based off of standardized x-rays and CBCT.
Baseline, 6mo & 12mo after baseline

Collaborators and Investigators

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

Sponsor

University of Michigan

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)

December 1, 2012

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 13, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Actual)

July 11, 2017

Last Update Submitted That Met QC Criteria

June 8, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00041254

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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