Bone Remodeling After Immediate Implant Placement With and Without Bone Grafting

NCT ID: NCT02174198

Last Updated: 2019-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2018-08-31

Brief Summary

This study compares two ways of placing a dental implant on the day of tooth extraction. One method will place a additional bone graft (derived from bovine bone) and the other group will not have the graft placed. Both groups will be restored at the same time with an immediate crown.

The investigators will be researching and comparing the changes in gum level that occur after each surgical method, as well as changes in jaw width where the implant is placed.

The investigators will enroll 16 patients per group. The patients will be followed for 3, 6, and 12 months post-immediate implant placement to observe healing.

Detailed Description

The purpose of the current study is to evaluate the soft tissue dimensional changes after extraction of teeth in the esthetic zone, when combined with the placement of implants into these fresh extraction sockets. In addition, the effect of placing a graft material, such as Bio-Oss Collagen® into the gap between implant and the labial plate of bone will be evaluated after an immediately loaded provisional restoration is placed. 32 subjects will have an immediate dental implant placed in the maxillary anterior region (#4-12) after extraction of a hopeless tooth. 16 subjects will be randomly selected to receive Bio-Oss Collagen® (Test group) and 16 subjects will have no graft (Control group) in the gap between the implant and the labial plate of bone. Hopeless maxillary anterior teeth will be extracted and implants will be placed in a flapless procedure. Implants will be immediately loaded with provisional restorations once determined that the implant is stable. Changes in vertical height and horizontal dimensional changes of the free gingival margins will be evaluated at 3, 6, and 12 months post-immediate implant placement.

Conditions

Tooth Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BioOss Collagen

Intervention: BioOss Collagen at the time of implant placement

Group Type: EXPERIMENTAL

BioOss Collagen at the time of implant placement

Intervention Type: DEVICE

Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen

No Bone Graft

No placement of BioOss at the time of implant placement

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

BioOss Collagen at the time of implant placement

Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen

Intervention Type: DEVICE

Other Intervention Names

BioOss Collagen, Geistlich Pharma Inc.

Eligibility Criteria

Inclusion Criteria

1. Subject must have read, understood and signed an informed consent form.

2. Subjects must be willing and able to follow study procedures and instructions.

3. Subjects must have labial plate of bone present after extraction no more than 4 mm from the free gingival margin.

4. Subjects must require one maxillary anterior implant.

5. Subjects must be older than 18 years

Exclusion Criteria

1. Subjects having participated within the last six months in other clinical studies.

2. Subjects who have failed to maintain good plaque control.

3. Subjects with any systemic condition like uncontrolled diabetes mellitus, cancer, human immunodeficiency virus (HIV), disorders that compromise wound healing, chronic high dose steroid therapy, bone metabolic diseases, radiation or other immuno-suppressive therapy which would preclude periodontal surgery.

4. Subjects with the presence of acute infectious lesions in the areas intended for surgery.

5. History within the last 6 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking and cigarette smoking (greater than 10 cigarettes per day).

6. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study.

7. Subjects on Bisphosphonate Therapy with C-terminal telopeptide (CTX) values <100

8. Subjects requiring antibiotic prophylaxis for subacute bacterial endocarditis (SBE) or late prosthetic joint infection. Patients who cannot undergo standard oral surgery procedure for any reason.

9. Subjects that have adjacent teeth next to tooth slated for extraction and immediate placement showing periodontal disease, endodontic and/or caries pathology will be excluded.

10. Subjects having unfavorable occlusal schemes for immediate loading, parafunctional habits and inadequate posterior support to properly protect the anterior teeth during function.

11. Implant site will not be next to an adjacent implant.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Geistlich Pharma AG

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Nurit Bittner Fogel

Assistant Professor of Dental Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nurit Bittner Fogel, DDS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University, College of Dental Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAM4053

Identifier Type: -

Identifier Source: org_study_id