Clinical trial NCT02174198: Bone Remodeling After Immediate Implant Placement With and Without Bone Grafting
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Loss
Keywords: Immediate implant
bone graft
immediate restoration
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Geistlich Pharma AG
First posted: 2014-06-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Bucco-Lingual Change at 3mm
timeFrame: Baseline and 12 months
measure: Mean Bucco-Lingual Change at 4mm
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in Vertical Dimension of Buccal Soft Tissue (Distal Papilla)
timeFrame: Baseline and 12 months
measure: Change in Vertical Dimension of Buccal Soft Tissue (Mid-buccal)
timeFrame: Baseline and 12 months
measure: Change in Vertical Dimension of Buccal Soft Tissue (Mesial Papilla)
timeFrame: Baseline and 12 months
measure: Periodontal Probing Depth
timeFrame: 12 months
measure: Thickness of Keratinized Tissue at 3mm
timeFrame: 12 months
measure: Thickness of Keratinized Tissue at 4mm
timeFrame: 12 months
measure: Thickness of Keratinized Tissue at 8mm
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University, College of Dental Medicine
state: New York
Study officials:
affiliation: Columbia University
name: Nurit Bittner Fogel, DDS
role: PRINCIPAL_INVESTIGATOR
References: