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Evaluation of Implants Placed Immediately or Delayed Into Extraction Sites

Primary Purpose

Dental Caries

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Dental Implant

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Partial edentulism, Bone atrophy, Bone healing

Eligibility Criteria

21 Months - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

LSU School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate implant placement

Delayed Implant

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01244997

First Posted

November 19, 2010

Last Updated

November 19, 2010

Sponsor

Louisiana State University Health Sciences Center in New Orleans

1. Study Identification

Unique Protocol Identification Number

NCT01244997

Brief Title

Evaluation of Implants Placed Immediately or Delayed Into Extraction Sites

Official Title

Prospective Evaluation of Immediate Temporized Implants

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

November 2003 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Louisiana State University Health Sciences Center in New Orleans

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

Partial edentulism, Bone atrophy, Bone healing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immediate implant placement

Arm Type

Experimental

Arm Description

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

Arm Title

Delayed Implant

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Dental Implant

Intervention Description

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 Outcome Measure Information:

Title

Crestal bone levels adjacent to the implants

Description

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Months

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

LSU School of Dentistry

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70119

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16094589

Citation

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.

Results Reference

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Evaluation of Implants Placed Immediately or Delayed Into Extraction Sites

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