Jaw, Edentulous, Partially3iNCT02021331
The Effect of Immediate Implant Placement and Provisionalization in the Esthetic Zone
A study testing immediate implant placement without provisionalization and immediate implant placement with immediate provisionalization in people with Jaw, Edentulous, Partially, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- immediate implant placement without provisionalization and immediate implant placement with immediate provisionalization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- immediate implant placement without provisionalization, immediate implant placement with immediate provisionalization
- Keywords
- jaw, edentulous, partially
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant placement without provisionalizationDevice
Also called BIOMET 3i Prevail Nanotite Certain - dental implant, Encode abutment
immediate implant placement with immediate provisionalizationDevice
Also called BIOMET 3i Prevail Nanotite Certain - dental implant, Encode abutment
| Study group | Role | What they receive |
|---|---|---|
| immediate implant placement without provisionalization | Active comparator | 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. Receives: Device: immediate implant placement without provisionalization |
| immediate implant placement with immediate provisionalization | Experimental | 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. Receives: Device: immediate implant placement with immediate provisionalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft Tissue Diemensional Change
Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.
Measured: Baseline, 12mo after baseline
Secondary outcomes (1)
Implant Survival
Checking to make sure the implant is stable.
Measured: 2wk, 4wk, 6wk, 3mo, 6mo, 12mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startDec 2012
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Low enrollment so sponsor stopped funding the study (did not renew)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Jaw, Edentulous, PartiallyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert M. Eber, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021331
- Sponsor's protocol ID
- HUM00041254
- Acronym
- 3i
- Status last verified
- Jun 2017
- First submitted
- 13 Dec 2013
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Immediate Implant Placement and Provisionalization in The Esthetic Zone: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02021331
- Acronym / sponsor ID
- 3i / HUM00041254
- Conditions
- Jaw, Edentulous, Partially
- Keywords
- jaw, edentulous, partially
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment so sponsor stopped funding the study (did not renew)
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Posted 28 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate implant placement without provisionalization | Active comparator | Device: immediate implant placement without provisionalizationThe 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 | Experimental | Device: immediate implant placement with immediate provisionalizationThe 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immediate implant placement without provisionalizationAlso: BIOMET 3i Prevail Nanotite Certain - dental implant, Encode abutment | Device | immediate implant placement without provisionalization |
| immediate implant placement with immediate provisionalizationAlso: BIOMET 3i Prevail Nanotite Certain - dental implant, Encode abutment | Device | immediate implant placement with immediate provisionalization |
Primary outcome
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.
1 secondary outcome
Implant Survival
Time frame: 2wk, 4wk, 6wk, 3mo, 6mo, 12mo
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate implant placement without provisionalization and immediate implant placement with immediate provisionalization in people with Jaw, Edentulous, Partially, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft Tissue Diemensional Change (time frame: Baseline, 12mo after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.