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

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ClinicalTrials.gov Identifier: NCT02021331
Recruitment Status : Terminated (Low enrollment so sponsor stopped funding the study (did not renew))
First Posted : December 27, 2013
Results First Posted : April 28, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Robert M. Eber, University of Michigan

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Jaw, Edentulous, Partially Device: immediate implant placement without provisionalization Device: immediate implant placement with immediate provisionalization Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Immediate Implant Placement and Provisionalization in The Esthetic Zone: A Randomized Clinical Trial
Actual Study Start Date : December 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Implant Survival [ Time Frame: 2wk, 4wk, 6wk, 3mo, 6mo, 12mo ]
    Checking to make sure the implant is stable.


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021331


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
More Information
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Responsible Party: Robert M. Eber, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT02021331    
Other Study ID Numbers: HUM00041254
First Posted: December 27, 2013    Key Record Dates
Results First Posted: April 28, 2017
Last Update Posted: July 11, 2017
Last Verified: June 2017
Keywords provided by Robert M. Eber, University of Michigan:
jaw, edentulous, partially
Additional relevant MeSH terms:
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Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases
Ethanol
Povidone-Iodine
Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
 Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants