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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02227719
Study type Interventional
Source University of Michigan
Contact
Status Withdrawn
Phase Phase 4
Start date September 2015
Completion date June 2016

See also
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Completed NCT03501537 - Association of Keratinised Mucosa Around Implants and Teeth With Peri-implant/Periodontal Disease and Soft Tissue Conditioning N/A