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OpenTrials
Completed

NCT Number: NCT01244997

Evaluation of Implants Placed Immediately or Delayed Into Extraction Sites

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.

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Key information

Age range

21 month–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

LSU School of Dentistry

New Orleans, Louisiana, 70119, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dental implant

Procedure

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.

Primary outcomes

  1. Crestal bone levels adjacent to the implants

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Registry information

Official study title

Prospective Evaluation of Immediate Temporized Implants

Important dates

Study start
2003
Primary completion
2008
Study completion
2009
First posted
Nov 22, 2010
Registry last updated
Nov 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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