Missing ToothNCT02397044
"Prospective Evaluation of Immediate & Early Loading of Zimmer Hydroxyapatite Coated Dental Implants"
An observational study of Missing Tooth, run by Louisiana State University Health Sciences Center in New Orleans.
Trial summary
The purpose of this study is to compare the success rates of two surgical protocols. One protocol will have the implants placed at the time of tooth extraction and placed into function. The other protocol will have the implants placed into healed extraction sites and placed into function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Missing Tooth
- What is being tested?
- Implant surgery
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers over the age of 18 needing a tooth replacement.
Who may be able to join
- May be either male or female
- Must be at least 18 years of age
- Must be of sufficiently good health to undergo routine dental treatment. including the surgical procedures associated with placement of dental implants.
- Must be partially edentulous requiring single dental implants in their maxilla or mandible
- Must have sufficient amount of native bone or healed bone grafted sites (by socket grafting, maxillary sinus augmentation and ridge augmentation).
- Must not have any active infection
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- Must have adequate bone height for at least a 10mm long dental implant
- Must be physically, emotionally and financially able to undergo the surgical procedure planned
- Must be adequately compliant
- -
Who cannot join
- Have any requirements for antibiotic premedication for infective endocarditis, artificial joints or any other condition
- Have uncontrolled hypertension
- Have uncontrolled diabetes
- Are serological HIV positive
- Have a history of significant heart, stomach, liver, kidney, blood, immune system or other organ impairment or systemic disease that would prevent their undergoing the proposed treatment
- Smoke cigarettes or use other tobacco products
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- Have taken any investigational drugs anytime in the previous month
- Have dental conditions likely to require treatment, necessitating exit from the study such as deep cavities, abscesses, or moderate-severe gum disease
- Have had radiation therapy to the head and neck
- Are unwilling or unable to sign the informed consent
- Don't demonstrate willingness to return for a required number of visits
- Need an immediate dental implant placement following tooth extraction
- -
About this study
Official title: Immediate and Early Loading of Hydrothermally Treated, Hydroxyapatite-Coated Dental Implants:a Controlled Randomized Prospective Clinical Study
The purpose of this study is to compare the success rates of two surgical protocols. One protocol will have the implants placed at the time of tooth extraction and placed into function. The other protocol will have the implants placed into healed extraction sites and placed into function.
Read the detailed description
Forty-eight patients (22 men, 26 women) were enrolled in the study and received 48 implants. The population was divided into 2 groups: Group A implants (n=23) were loaded immediately on the day of surgery and Group B implants (n=19) were loaded 3 weeks after surgery. Cone Beam Computed Tomography (CBCT) scans were taken preoperatively to aid in treatment planning. Bone density was evaluated on CBCT scans in Hounsfield units (HU) and by tactile feedback during surgery. Insertion torque was recorded at time of implant placement. Resonance frequency analysis, performed on the day of surgery, at the time of loading, and at 6, 12 and 24 months, was used to record implant stability according to the unit's Implant Stability Quotient (Osstell ISQ). Standardized radiographs were taken at time of implant placement and at 6, 12 and 24 months to measure crestal bone stability. Bone level changes were measured by software (Image J, available online at: http://rsbweb.nih.gov/ij/download.html; last accessed 28 August 2014).
- Conditions
- Missing Tooth
- Being tested
- Implant surgery
- Keywords
- Implants, stability, loading
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant surgeryProcedure or surgery
Compare surgical protocols
| Study group | Role | What they receive |
|---|---|---|
| Implant loading Immediate | Dental implant surgery with immediate loading Receives: Procedure: Implant surgery | |
| Implant Loading Early | Dental implant surgery with delayed loading Receives: Procedure: Implant surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint Measurement: Implant survival
The primary endpoint for this protocol is implant survival.
Measured: 6 months
Secondary Endpoint Measurements: Crestal Bone Loss, ISQ
Implant survival
- Crestal Bone Loss will be determined radiographically and will be defined as having occurred when greater than 1.5 mm of bone loss is evident. This endpoint will be summarized for the subgroups of the study population which are formed by stratifying on implant diameter, implant length, implant location and patient age. Rates of crestal bone loss will be computed at one year.
- ISQ will be measured at the time of implant placement, at 5 months and at one year post implant placement. Insertion torque will be measured at time of placement only.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing ToothStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Dental
- Responsible party
- Principal investigator, David E. Simmons D.D.S., Louisiana State University Health Sciences Center in New Orleans
- Investigators
- David E Simmons, D.D.S., Principal investigator, LSU Helath Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397044
- Sponsor's protocol ID
- IRB 7438
- Status last verified
- Mar 2015
- First submitted
- 18 Mar 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Early Loading of Hydrothermally Treated, Hydroxyapatite-Coated Dental Implants:a Controlled Randomized Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT02397044
- Acronym / sponsor ID
- IRB 7438
- Conditions
- Missing Tooth
- Keywords
- Implants, stability, loading
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- Zimmer Dental
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
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 the success rates of two surgical protocols. One protocol will have the implants placed at the time of tooth extraction and placed into function. The other protocol will have the implants placed into healed extraction sites and placed into function.
Detailed description
Forty-eight patients (22 men, 26 women) were enrolled in the study and received 48 implants. The population was divided into 2 groups: Group A implants (n=23) were loaded immediately on the day of surgery and Group B implants (n=19) were loaded 3 weeks after surgery. Cone Beam Computed Tomography (CBCT) scans were taken preoperatively to aid in treatment planning. Bone density was evaluated on CBCT scans in Hounsfield units (HU) and by tactile feedback during surgery. Insertion torque was recorded at time of implant placement. Resonance frequency analysis, performed on the day of surgery, at the time of loading, and at 6, 12 and 24 months, was used to record implant stability according to the unit's Implant Stability Quotient (Osstell ISQ). Standardized radiographs were taken at time of implant placement and at 6, 12 and 24 months to measure crestal bone stability. Bone level changes were measured by software (Image J, available online at: http://rsbweb.nih.gov/ij/download.html; last accessed 28 August 2014).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implant loading Immediate | – | Procedure: Implant surgeryDental implant surgery with immediate loading |
| Implant Loading Early | – | Procedure: Implant surgeryDental implant surgery with delayed loading |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers over the age of 18 needing a tooth replacement.
Key inclusion criteria (10 listed)
- May be either male or female
- Must be at least 18 years of age
- Must be of sufficiently good health to undergo routine dental treatment. including the surgical procedures associated with placement of dental implants.
- Must be partially edentulous requiring single dental implants in their maxilla or mandible
- Must have sufficient amount of native bone or healed bone grafted sites (by socket grafting, maxillary sinus augmentation and ridge augmentation).
Key exclusion criteria (13 listed)
- Have any requirements for antibiotic premedication for infective endocarditis, artificial joints or any other condition
- Have uncontrolled hypertension
- Have uncontrolled diabetes
- Are serological HIV positive
- Have a history of significant heart, stomach, liver, kidney, blood, immune system or other organ impairment or systemic disease that would prevent their undergoing the proposed 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 |
|---|---|---|
| Implant surgeryCompare surgical protocols | Procedure or surgery | Implant Loading Early, Implant loading Immediate |
Primary outcome
Primary Endpoint Measurement: Implant survival
Time frame: 6 months
The primary endpoint for this protocol is implant survival.
Secondary Endpoint Measurements: Crestal Bone Loss, ISQ
Time frame: 1 year
Implant survival * Crestal Bone Loss will be determined radiographically and will be defined as having occurred when greater than 1.5 mm of bone loss is evident. This endpoint will be summarized for the subgroups of the study population which are formed by stratifying on implant diameter, implant length, implant location and patient age. Rates of crestal bone loss will be computed at one year. * ISQ will be measured at the time of implant placement, at 5 months and at one year post implant placement. Insertion torque will be measured at time of placement only.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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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.
David E Simmons, D.D.S. principal investigator
LSU Helath Sciences Center
Questions about this trial
What is this clinical trial studying?
An observational study of Missing Tooth, run by Louisiana State University Health Sciences Center in New Orleans.
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 10 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Primary Endpoint Measurement: Implant survival (time frame: 6 months). The study lists 2 primary outcomes in all. 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 24 Mar 2015.