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Bone Remodeling After Immediate Implant Placement With and Without Bone Grafting

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ClinicalTrials.gov Identifier: NCT02174198
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Geistlich Pharma AG
Information provided by (Responsible Party):
Nurit Bittner Fogel, Columbia University

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.


Condition or disease Intervention/treatment Phase
Tooth Loss Device: BioOss Collagen at the time of implant placement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Esthetic Effect of Bio-OSS Collagen® on the Mid-facial Gingival Dimensions When Placed Into Gaps Between 3i® Implants Placed Into Fresh Extraction Sockets and the Labial Plate of Bone
Actual Study Start Date : January 2014
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts
Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: BioOss Collagen
Intervention: BioOss Collagen at the time of implant placement
Device: BioOss Collagen at the time of implant placement
Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen
Other Name: BioOss Collagen, Geistlich Pharma Inc.

No Intervention: No Bone Graft
No placement of BioOss at the time of implant placement



Primary Outcome Measures :
  1. Height of Keratinized Tissue [ Time Frame: Up to 24 months ]
    Measured at 3,6,12, 24 months post surgery.

  2. Thickness of Keratinized Tissue [ Time Frame: Up to 24 months ]
    Measured at 3,6,12, 24 months post surgery.


Secondary Outcome Measures :
  1. Periodontal Probing Depth [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174198


Locations
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United States, New York
Columbia University, College of Dental Medicine
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Geistlich Pharma AG
Investigators
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Principal Investigator: Nurit Bittner Fogel, DDS Columbia University

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Responsible Party: Nurit Bittner Fogel, Assistant Professor of Dental Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT02174198     History of Changes
Other Study ID Numbers: AAAM4053
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Nurit Bittner Fogel, Columbia University:
Immediate implant
bone graft
immediate restoration

Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases