NCT02227719

Customized Titanium Membrane for Growing Jaw Bone Horizontally

The Use of Customized Titanium Membrane for Horizontal Ridge Augmentation With Simultaneous Implant Placement

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A single center, randomized, controlled, parallel-arm study is planned to investigate clinical outcomes of horizontal ridge augmentation with simultaneous single implant placement, using the newly designed Ti-membrane. Twenty-four adult subjects who fulfill the inclusion criteria will be enrolled. They will be randomly placed into one of two treatment groups: the customized titanium membrane (Cti-mem) or the collagen membrane (CM) group as a control. The decision of which material to use will be made after an implant is placed. Primary closure of the surgical site will be attempted for 4 months (+/- 1 month), after which the implants will be surgically uncovered and restored. Outcome analyses will be performed until 1-year after the crown will be placed, or 18 months (- 1 or +4 months) from the implant surgery. Clinical and radiographic parameters will be compared between the two experimental groups. The primary outcome is linear increase of horizontal ridge width from direct measurements.

Conditions

• Bone Gain

Interventions

Type	Name	Description
DEVICE	CTI	CTI is the titanium mesh
DEVICE	Collagen membrane

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-01-01
• Completion: 2016-06-01
• First posted: 2014-08-28
• Last updated: 2023-12-11

Locations

1 site across 1 country: United States