Bone Remodeling After Immediate Implant Placement With and Without Bone Grafting

Completed · Not applicable

Conditions studied: Tooth Loss

In brief

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.

Key facts

Study ID

NCT02174198

Run by

Columbia University

People needed

32

Starts

2014-01-01

Expected to finish

2018-08-01

Last updated by the study team

2019-06-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject must have read, understood and signed an informed consent form.
• Subjects must be willing and able to follow study procedures and instructions.
• Subjects must have labial plate of bone present after extraction no more than 4 mm from the free gingival margin.
• Subjects must require one maxillary anterior implant.
• Subjects must be older than 18 years

You may not qualify if…

• Subjects having participated within the last six months in other clinical studies.
• Subjects who have failed to maintain good plaque control.
• 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.
• Subjects with the presence of acute infectious lesions in the areas intended for surgery.
• 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).
• Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study.
• Subjects on Bisphosphonate Therapy with C-terminal telopeptide (CTX) values <100
• 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.
• 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.
• Subjects having unfavorable occlusal schemes for immediate loading, parafunctional habits and inadequate posterior support to properly protect the anterior teeth during function.
• Implant site will not be next to an adjacent implant.

Where it is running

• Columbia University, College of Dental Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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