Bone Remodeling After Immediate Implant Placement With and Without Bone Grafting

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Tooth Loss

Intervention / Treatment
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* Device: BioOss Collagen at the time of implant placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioOss Collagen<br>Intervention: BioOss Collagen at the time of implant placement | Device: BioOss Collagen at the time of implant placement<br>* Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen<br>* Other names: BioOss Collagen, Geistlich Pharma Inc.;|
| No Intervention: No Bone Graft<br>No placement of BioOss at the time of implant placement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Bucco-Lingual Change at 3mm | The horizontal dimensional change from a digital superimposition at 3mm apical to the baseline free gingival margin position was measured. | Baseline and 12 months | 
| Mean Bucco-Lingual Change at 4mm | The horizontal dimensional change from a digital superimposition at 4mm apical to the baseline free gingival margin position was measured. | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vertical Dimension of Buccal Soft Tissue (Distal Papilla) | The mean change was calculated from a tooth-supported stent to the free gingival margin. | Baseline and 12 months | 
| Change in Vertical Dimension of Buccal Soft Tissue (Mid-buccal) | The mean change was calculated from a tooth-supported stent to the free gingival margin. | Baseline and 12 months | 
| Change in Vertical Dimension of Buccal Soft Tissue (Mesial Papilla) | The mean change was calculated from a tooth-supported stent to the free gingival margin. | Baseline and 12 months | 
| Periodontal Probing Depth | The periodontal probing depth will be measured in mm. | 12 months | 
| Thickness of Keratinized Tissue at 3mm | Tissue thickness was measured at 3mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper. | 12 months | 
| Thickness of Keratinized Tissue at 4mm | Tissue thickness was measured at 4mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper. | 12 months | 
| Thickness of Keratinized Tissue at 8mm | Tissue thickness was measured at 8mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immediate implant, bone graft, immediate restoration