Evaluation of Implants Placed Immediately or Delayed Into Extraction Sites

This study has been completed.
Sponsor:
Information provided by:
Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier:
NCT01244997
First received: November 19, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

IRB4729 Study Hypothesis: Is there a significant difference in the hard and soft tissue response comparing immediate with delayed implant after tooth removal, with immediate provisionalization, in maxillary anterior sites.

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.


Condition Intervention Phase
Dental Caries
Procedure: Dental Implant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Immediate Temporized Implants

Resource links provided by NLM:


Further study details as provided by Louisiana State University Health Sciences Center in New Orleans:

Primary Outcome Measures:
  • Crestal bone levels adjacent to the implants [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    An evaluation of crestal bone level changes when implants are placed into extraction sites. Levels will be measured on standardized digital radiographs of the implants using their threads as a monitor of magnification and a preextraction reference in the measurement.


Enrollment: 75
Study Start Date: November 2003
Study Completion Date: May 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate implant placement
This arm is an immediate placement of a dental implant following tooth extraction.
Procedure: 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.
Active Comparator: Delayed Implant
This is the traditional method for implants. This arm will be done following a healing of the area.
Procedure: 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

Ages Eligible for Study:   21 Months to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients will be willing to be present for examination two times a year for at least three years, as well as maintenance cleaning twice a year 3 months prior to the data collection visit
  • 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 with labial dehiscence defects greater than 3mm from the proposed gingival margin of the planned restoration will be excluded from this study.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244997

Locations
United States, Louisiana
LSU School of Dentistry
New Orleans, Louisiana, United States, 70119
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
  More Information

Publications:
Responsible Party: Michael S. Block DMD, LSU School of Dentistry
ClinicalTrials.gov Identifier: NCT01244997     History of Changes
Other Study ID Numbers: IRB4729
Study First Received: November 19, 2010
Last Updated: November 19, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Louisiana State University Health Sciences Center in New Orleans:
Partial edentulism
Bone atrophy
Bone healing

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 23, 2014