NCT02174198

Bone Remodeling After Immediate Implant Placement With and Without Bone Grafting

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	BioOss Collagen at the time of implant placement	Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2014-06-25
• Last updated: 2019-06-13
• Results posted: 2019-06-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study