Evaluation of Implants Placed Immediately or Delayed Into Extraction Sites

NCT01244997 | Completed Phase 3

• 1 other identifier: IRB4729
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries

Keywords

Partial edentulism; Bone atrophy; Bone healing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Immediate implant placement

EXPERIMENTAL

This arm is an immediate placement of a dental implant following tooth extraction.

Procedure: Dental Implant

Delayed Implant

ACTIVE COMPARATOR

This is the traditional method for implants. This arm will be done following a healing of the area.

Procedure: Dental Implant

Interventions

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.

Delayed Implant; Immediate implant placement

Eligibility Criteria

• Age: 21 Months - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead

Study Sites (1)

LSU School of Dentistry

New Orleans, Louisiana, 70119, United States

Location

Related 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. doi: 10.1016/j.joms.2005.04.025.

  PMID: 16094589 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 22, 2010
• Study Start: November 1, 2003
• Primary Completion: April 1, 2008
• Study Completion: May 1, 2009
• Last Updated: November 22, 2010

Record last verified: 2010-11

Locations

US (1)