Evaluation of Implants Placed Immediately or Delayed Into Extraction Sites

Dental Caries Clinical Trial

Official title:

Prospective Evaluation of Immediate Temporized Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244997
• Other study ID #: IRB4729
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2010
• Last updated: November 19, 2010
• Start date: November 2003
• Est. completion date: May 2009

Study information

• Verified date: November 2010
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Months to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

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.

Locations

Country	Name	City	State
United States	LSU School of Dentistry	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crestal bone levels adjacent to the implants	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.	24 months	Yes