Evaluation of Implants Placed Immediately or Delayed Into Extraction Sites
NCT ID: NCT01244997
Last Updated: 2010-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
75 participants
INTERVENTIONAL
2003-11-30
2009-05-31
Brief Summary
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The purpose of this study is to determine and compare the crestal bone levels as the primary endpoint variable for implants placed and temporized in extraction sites, to implants placed into extraction sites after the extraction site has been grafted and healed for 4 months, all immediately restored with an anatomic provisional restoration.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Immediate implant placement
This arm is an immediate placement of a dental implant following tooth extraction.
Dental Implant
This is designed to compare the response of the crestal bone after implants are placed whether delayed or immediately after tooth extraction in the maxilla.
Delayed Implant
This is the traditional method for implants. This arm will be done following a healing of the area.
Dental Implant
This is designed to compare the response of the crestal bone after implants are placed whether delayed or immediately after tooth extraction in the maxilla.
Interventions
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Dental Implant
This is designed to compare the response of the crestal bone after implants are placed whether delayed or immediately after tooth extraction in the maxilla.
Eligibility Criteria
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Inclusion Criteria
* All patients will be free of uncontrolled diabetes (any type, existing malignancy, and will not be receiving any therapy that suppresses their immune system, such as radiation, chemotherapy, or chronic steroid usage
* Need for extraction of a single rooted maxillary central or lateral incisor, canine, or premolar, with no signs of acute infection (purulent exudate, erythema, pain and swelling).
* Patients will have bone present on all surfaces of the tooth within 3mm of the gingival margin of the planned restoration, in order to provide sufficient bone to circumferentially cover the implant.
* all patients will have adequate space for satisfactory restoration of the edentulous space.
* each patients dentition will be free of active periodontal disease or exhibit controllable periodontal disease such that their teeth will clinically be non-mobile and have probing depths less than 3mm.
* All prospective sites will have at least 2mm of attached or keratinized gingiva.
* The crestal bone width should be enough to accommodate either a 3.75mm diameter implant for the central incisor, canine, and premolar sites or a 3.25 mm diameter implant for the lateral incisor tooth sites. Bone heights should be at least 14mm for accommodation of the implant.
Exclusion Criteria
* Patients who cannot come for follow up due to conflicts of schedules will not be accepted into the study.
* Patients with advanced cardiovascular, pulmonary, renal, liver disease that place them in an ASA III or IV rating will be excluded. Post-menopausal women with known osteoporosis as determined by their medical internist, will be excluded. Patients with known alcohol abuse will be excluded.
21 Months
65 Years
ALL
Yes
Sponsors
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Louisiana State University Health Sciences Center in New Orleans
OTHER
Responsible Party
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LSU School of Dentistry
Locations
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LSU School of Dentistry
New Orleans, Louisiana, United States
Countries
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References
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Ryser MR, Block MS, Mercante DE. Correlation of papilla to crestal bone levels around single tooth implants in immediate or delayed crown protocols. J Oral Maxillofac Surg. 2005 Aug;63(8):1184-95. doi: 10.1016/j.joms.2005.04.025.
Other Identifiers
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IRB4729
Identifier Type: -
Identifier Source: org_study_id