Study Stopped
Low enrollment so sponsor stopped funding the study (did not renew)
The Effect of Immediate Implant Placement and Provisionalization in the Esthetic Zone
3i
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 13, 2013
CompletedFirst Posted
Study publicly available on registry
December 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
April 28, 2017
CompletedJuly 11, 2017
June 1, 2017
3.3 years
December 13, 2013
March 20, 2017
June 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Soft Tissue Diemensional Change
Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.
Baseline, 12mo after baseline
Secondary Outcomes (1)
Implant Survival
2wk, 4wk, 6wk, 3mo, 6mo, 12mo
Other Outcomes (1)
Bony Dimensional Changes
Baseline, 6mo & 12mo after baseline
Study Arms (2)
immediate implant placement without provisionalization
ACTIVE COMPARATORThe 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.
immediate implant placement with immediate provisionalization
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Robert Eber
- Organization
- University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 13, 2013
First Posted
December 27, 2013
Study Start
December 1, 2012
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
July 11, 2017
Results First Posted
April 28, 2017
Record last verified: 2017-06